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Study Objectives
This phase II trial is studying how well cilengitide works in treating patients with prostate cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor
Conditions: Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
Intervention / Treatment:
DRUG: cilengitide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* A histologic or cytologic diagnosis of prostate cancer
* No evidence of metastatic disease, or local progression
* PSA-only progression despite androgen deprivation therapy and antiandrogen withdrawal (28 days for flutamide and 42 days for bicalutamide or nilutamide); PSA progression is defined as 3 consecutive rising levels, with an interval of > 1 week between each determination; the last determination must have a minimum value of >= 2 ng/ml and be determined within two weeks prior to registration
* If the third confirmatory value is less than the previous value, the patient will still be eligible if a repeat value (No. 4) is found to be greater than the second value
* Patients must continue on LHRH agonists; they also may continue on any stable doses (considered stable, if on current medicine dosing for one month or longer) of megace or corticosteroids; they must be off all other therapies intended to treat the cancer for 4 weeks
* ECOG performance status of 0 <= age <= 2
* No prior EMD 121974 therapy is allowed
* No investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy
* Testosterone < 50 ng/dl; patients must continue primary androgen deprivation with an LHRH agonist, if they have not undergone orchiectomy
* Four weeks must have elapsed since major surgery
* Life expectancy of greater than 6 months
* Patients must have normal organ and marrow function as defined below obtained within 14 days prior to registration:
* ANC >= 1,500/µl
* Platelet count >= 100,000/ µl
* Creatinine =< 1.5 x upper limits of normal
* Bilirubin within normal limits
* SGOT (AST) =< 2.5 x upper limits of normal
* SGPT (ALT) =< 2.5 x upper limits of normal
* PSA >= 2 ng/ml
* The effects of EMD 121974 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because antiangiogenic agents are known to be teratogenic, men must agree to use adequate contraception prior to study entry and for the duration of study participation
* Ability to understand and the willingness to sign a written informed consent that is approved by the Institutional Human Investigation Committee
Exclusion Criteria:
* Patients may continue on a daily Multi-Vitamin, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration
* Patients on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy, that show subsequent PSA progression, may continue on this medication, however patients are not allowed to initiate bisphosphonate therapy immediately prior or during the study
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with a "currently active" second malignancy, other than non-melanoma skin cancers or superficial bladder cancer, are not eligible; patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered without evidence of disease for 2 years
|
NCT_ID
NCT00121238
|
Study_NameCilengitide in Treating Patients With Prostate Cancer
| 14,498 |
Study Objectives
The goal of this clinical trial is to learn if high-dose Melphalan HCl for Injection works to treat multiple myeloma. It will also learn about the safety of high dose Melphalan HCl for Injection. The main questions it aims to answer are:
Does high-dose Melphalan HCl for Injection deplete bone marrow activity which results in a better outcome of patients'own stem cell (blood-forming cell) transplantation? What medical problems do participants have when taking high-dose Melphalan HCl for Injection? How fast is the high-dose Melphalan HCl for Injection cleared out from blood?
Participants will:
* Take high-dose Melphalan HCl for Injection for 2 days
* Have stem cell transplantation one day after treatment
* Stay in the hospital for at least 10days and visit the clinic once every week for the first month after transplantation and every month after for checkups and tests.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Melphalan Hydrochloride for Injection
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Diagnosed as symptomatic multiple myeloma, according to the International Myeloma Working Group's IMWG Guidelines for the Diagnosis and Treatment of Multiple Myeloma, treatment is necessary and suitable for autologous hematopoietic stem cell transplantation;
* When signing the informed consent form, males and females aged >= 18 years and <= 65 years;
* Adequate autologous hematopoietic stem cells were collected, defined as peripheral blood stem cells containing at least 2 x 106 CD34+cells/kg that have not been manipulated or refrigerated;
* Important organ functions meet the following conditions:
i. Echocardiography indicates left ventricular ejection fraction (LVEF) >= 40%;
ii. Serum total bilirubin<2 times the upper limit of normal value, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<3 times the upper limit of normal value;
Iii. creatinine clearance rate>60 mL/min ;
Iv. Blood oxygen saturation>92% in non oxygenated state, without significant ventilation or ventilation dysfunction;
* The Eastern Oncology Collaborative Group (ECOG) physical fitness status of the subjects is 0, 1, or 2;
* The subject or their legal guardian voluntarily signs an informed consent form approved by the ethics committee before participating in the study, and agrees to complete the entire study treatment according to the clinical trial protocol.
Exclusion Criteria:
* Multiple myeloma subjects without treatment indications;
* Suffering from plasma cell leukemia;
* Suffering from systemic amyloidosis;
* Subjects with extramedullary plasma cell tumors did not reach PR after induction therapy;
* Suffering from POEMS syndrome (multiple peripheral neuropathy, organ enlargement, endocrine disorders, M-proteinemia, skin changes);
* Suffering from Fahrenheit macroglobulinemia;
* Subjects with non secretory multiple myeloma;
* Subjects with active bacterial, viral, or fungal infections who require oral or intravenous antibiotic treatment according to the researcher's judgment;
* The expected survival period of the subjects is less than 6 months;
* Previously suffering from other malignant tumors, except for cured basal cell carcinoma or cervical carcinoma in situ. Malignant tumors that have undergone curative treatment and achieved complete remission (CR) for more than 5 years can be enrolled. If malignant tumors receive curative treatment but have achieved complete remission (CR) for <= 5 years, they cannot be enrolled unless approved by the sponsor;
* Pregnant or lactating women;
* Subjects who have fertility and are unwilling to take appropriate contraceptive measures within 3 months after signing the informed consent form until the end of treatment in this study;
* Positive for human immunodeficiency virus (HIV) antibodies;
* Subjects with positive hepatitis B virus DNA;
* The subject receives other concurrent anti-tumor treatments (including chemotherapy, radiation therapy, hormone therapy, or immunotherapy) within 30 days prior to autologous hematopoietic stem cell transplantation, or plans to receive any such treatments before the last study visit on day 95 ± 5;
* The side effects of chemotherapy drugs received before administration have not yet recovered, defined as not regressing to level 0/1 of the National Cancer Institute's Common Terminology Standard for Adverse Events (NCI-CTCAE v5.0), or at the level specified in the inclusion/exclusion criteria, except for adverse events such as hair loss that the researcher assessed and deemed not to affect the safety of the subject's participation in this study;
* Allergy or intolerance to any component of the investigational drug formulation;
* Participants participate in other clinical trials within one month before signing the informed consent form;
* According to the researcher's judgment, subjects who are not suitable for enrollment, may affect treatment evaluation, or are at inappropriate risk.
|
NCT_ID
NCT06425276
|
Study_NameEvaluate Safety and Efficacy of High-dose Melphalan HCL for Injection in MM Patients With Auto-HSC Transplantation
| 3,508 |
Study Objectives
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.
Conditions: Chronic Myeloid Leukemia
Intervention / Treatment:
DRUG: Imatinib mesylate
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* CML Ph+ (assessed by cytogenetic or FISH)
* Age >= 18 year at inclusion
* PS grade 0 to 2 (ECOG)
* previous allogeneic stem cell transplantation
* molecular, cytogenetic or haematological relapse in chronic phase after transplantation
* Immune therapy for graft versus host disease stopped within 2 months from inclusion
* Adequate and organ function, defined as the following: total bilirubin <3x uln, sgpt <3x uln, creatinine <2x uln.
* informed consent sign up
Exclusion Criteria:
* Age less than 18 y
* accelerated or blastic phase
* previous therapy with imatinib
* active malignancy other than CML or non-melanoma cancer of the skin
* current treatment with another investigational agent
|
NCT_ID
NCT00219726
|
Study_NameSafety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
| 14,611 |
Study Objectives
This phase I trial is studying how well monoclonal antibody therapy with peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Peripheral stem cell transplant may allow the doctor to give higher doses of monoclonal antibodies and kill more cancer cells
Conditions: Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Small Cleaved Cell Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Small Lymphocytic Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia
Intervention / Treatment:
BIOLOGICAL: rituximab, DRUG: cyclophosphamide, BIOLOGICAL: filgrastim, RADIATION: yttrium Y 90 ibritumomab tiuxetan, PROCEDURE: peripheral blood stem cell transplantation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* All patients must have a biopsy-proven indolent or diffuse large B-cell non-Hodgkin's lymphoma as defined as REAL classification marginal zone/MALT, mantle cell, plasmacytoid, lymphoplasmacytoid, small lymphocytic lymphoma or follicle center grades I, II, III or diffuse large B-cell (CLL patients will not be eligible); transformation from a low grade to intermediate or high grade lymphoma is also permissible; patients with diffuse large cell lymphoma must not be eligible for any known potentially curative therapy; at least one diagnostic pathologic specimen will be reviewed by the JHH Pathology Department
* Patients must have received at least one but not more than five prior chemotherapy regimens for treatment of their lymphoma
* Patients may not have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
* Patients must have 0 <= age <= 35% morphologically identifiable tumor in the trabecular space on bone marrow biopsy; in patients with lymphomas in whom tumor is morphologically difficult to distinguish from normal cells, flow cytometry must show 0 <= age <= 35% identifiable tumor within 4 weeks of registration
* Patients must have =< 35% bone marrow involvement with tumor due to risk of engraftment failure
* Patients may not have hypocellular bone marrow (=< 15% cellularity) or marked decrease in any one (or more) hematopoietic precursor
* Patients may not have received prior murine compounds due to risk of HAMA formation
* WBC must be >= 3,000
* Total lymphocyte count must be < 5,000
* Hgb must be >= 10.0
* Platelets must be >= 75,000
* Serum creatinine must not be greater than 2.0 mg/dl
* Direct bilirubin must be =< 2mg/dl unless secondary to tumor
* AST or ALT must be < 2 x the upper limit of normal
* Normal (>= 45%) left ventricular cardiac ejection fraction, (determined by echocardiogram or MUGA scan)
* DLCO must be > 50% predicted
* Patients with active infections requiring oral or intravenous antibiotics are not eligible for entry onto the study until resolution of the infection
* ECOG performance status =< 2
* Not pregnant (confirmed by serum pregnancy test in females of reproductive potential) or breast feeding, because it is unknown what effect these drugs will have on children
* Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
* Patients with a second malignancy other than basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible unless the tumor was treated with curative intent at least two years previously
* Women and minorities are encouraged to participate
* Patients who have received prior anti-CD20 therapy must have achieved a partial or complete response
* Patients who are HIV positive will be excluded due to increased risk for bone marrow suppression and other toxicities
* Patients who have received prior radioimmunotherapy, for example Zevalin or Bexxar, are not eligible
|
NCT_ID
NCT00017381
|
Study_NameMonoclonal Antibody Therapy and Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma
| 14,068 |
Study Objectives
A randomized controlled trial to assess clinically the efficacy of the selective ileum spasmolytic mebeverine on daytime incontinence and nocturnal enuresis of orthotopic w-ileal neobladders and quality of life effect within 1 year post-surgery.
Conditions: Oncology, Incontinence, Incontinence, Daytime Urinary, Incontinence, Nighttime Urinary, Bladder Cancer, Orthotopic Neobladder
Intervention / Treatment:
DRUG: Coloverin, DRUG: Placebo
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE
|
Inclusion Criteria:
* Men >= 18 years
* ONB within 1 year post-surgery.
Exclusion Criteria:
* Upper urinary tract deterioration
* Uncontrolled diabetes mellitus
* Evident local or pelvic recurrence
* Adjuvant chemotherapy
* Chronic retention
* Pouch stones
* Urethral stricture or urethro-ileal maldirection
* Sensitivity to Mebeverine
* Untreated chronic constipation
* Active symptomatic urinary infection
|
NCT_ID
NCT03147599
|
Study_NameMebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders
| 12,400 |
Study Objectives
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal receptor 2-negative (HER2)- palbociclib-resistant breast cancer, and to determine the recommended Phase 2 dose (RP2D) for TTI-101 when added to palbociclib and AI or fulvestrant.
The primary objective of Phase 2 will be to evaluate anti-tumor activity in participants who receive TTI-101 added to palbociclib or ribociclib and AI or fulvestrant.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: TTI-101, DRUG: Palbociclib, DRUG: Aromatase inhibitor (AI), DRUG: fulvestrant, DRUG: ribociclib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
Participants must meet all the following criteria to be eligible:
* Age >=18 years at the time of informed consent.
* Metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
* For Phase 1b,currently receiving palbociclib and AI or fulvestrant; for Phase 2, currently receiving palbociclib or ribociclib and AI or fulvistrant therapy in the metastatic setting with evidence of progressive disease. In addition:
* Must have remained on palbociclib or ribociclib and AI or fulvestrant therapy for >=6 months for advanced breast cancer or metastatic disease prior to evidence of progression that in the opinion of the treating physician warrants continued therapy with palbociclib or ribociclib and AI or fulvestrant.
* Dosage of palbociclib, ribociclib, AI and fulvestrant must remain unchanged from regimen prior to study enrollment specifically palbociclib at a dose of 125, 100, or 75 mg administered orally for 21 days every 28-day cycle or ribociclib at a dose of 200, 400, or 600 mg administered orally for 21 days every 28-day cycle.
* All men and premenopausal women must be on medical gonadal suppression therapy with a gonadotropin analog (e.g, goserelin or leuprolide) and have estrogen levels in the postmenopausal range by institutional criteria at baseline.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Has documented confirmation of histological or cytological HR-positive, HER2-negative breast cancer per local laboratory testing.
* Up to 2 prior lines of systemic treatment (most recent line of therapy must be palbociclib and AI or fulvestrant for Phase 1b and palbociclib or ribociclib and AI or fulvestrant for Phase 2) in the locally advanced or metastatic setting is allowed; the participant must have shown evidence of progressive disease on palbociclib and AI or fulvestrant for Phase 1b and palbociclib or ribociclib and AI or fulvestrant for Phase 2 in the locally advanced or metastatic setting prior to enrollment.
* Willing to provide a representative fresh tumor tissue specimen prior to enrollment. The fresh tumor specimen must be obtained after evidence of progression on palbociclib and AI or fulvestrant for Phase 1b and palbociclib or ribociclib and AI or fulvestrant for Phase 2.
* Participants with bone only disease WITHOUT a soft tissue component, may opt out of the tumor biopsy.
* The presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 is preferred but not required. Lesions in a previously irradiated area that have not progressed are not considered measurable.
Exclusion Criteria:
Participants meeting any of the following exclusion criteria will not be eligible:
* Has received more than 2 lines of prior systemic therapy for locally advanced/metastatic breast cancer.
* Had prior exposure to any signal transducer and activator of transcription 3 (STAT3) inhibitor.
* Had radiotherapy within 3 weeks prior to Cycle 1 Day 1 (cycle is 28 days). Participants must have recovered from radiotherapy toxicities prior to starting study treatment and recovered to Grade 1 or better from related side effects of such therapy (with the exception of alopecia).
* Has HER2 overexpression by local laboratory testing (immunohistochemical [IHC] 3+ or in situ hybridization positive).
* Has known loss of retinoblastoma tumor suppressor gene (Rb) (testing not mandatory).
* Has had disease progression on more than two cyclin-dependent kinase (CDK)4/6 inhibitors. Adjuvant abemaciclib is allowed but must have progressed on palbociclib or ribociclib.
* Concurrently using other anticancer therapy. Participants must continue palbociclib and AI or fulvestrant for Phase 1b and palbociclib or ribociclib and AI or fulvestrant for Phase 2.
|
NCT_ID
NCT05384119
|
Study_NamePhase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
| 7,703 |
Study Objectives
This study was a randomized, single dose crossover comparison of the investigational product with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective was to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.
Conditions: Breast Cancer, Non-small Cell Lung Cancer, Non-Hodgkins Lymphoma
Intervention / Treatment:
DRUG: Vinorelbine Tartrate
Location: Argentina
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* Age > 18 years.
* Advanced cancer potentially sensitive to vinorelbine:
* Breast cancer.
* Stage 3 or 4 non-small cell lung cancer.
* Non-Hodgkins lymphoma.
* Cancer of other histologic type, sensitive to vinca alkaloids.
* Rare tumor type with no standard treatment, for which single agent vinorelbine is appropriate therapy.
* Failure of standard treatment(s) of the tumor.
* Life expectancy of at least three months.
* ECOG performance level 0 <= age <= 2 or Karnofsky score 100 <= age <= 70.
* Hematological and serum chemistry results with defined ranges.
* Willingness and ability to provide written informed consent.
Exclusion Criteria:
* Pregnancy or lactation. In a woman of childbearing potential, a positive pregnancy test result, no pregnancy test result, or no use of reliable contraception, at baseline. A postmenopausal woman will be considered to be of childbearing potential until there has been amenorrhea for at least 12 consecutive months.
* Previous treatment with vinorelbine or mitomycin.
* Any history suggesting or demonstrating resistance to, lack of response to, or intolerance of any prior vinca alkaloid treatment.
* Active infection.
* Prior anticancer therapy completed within four weeks prior to the first day of study treatment.
* Failure to have recovered from any toxicity of previous cancer treatment (patients with alopecia will not be excluded).
* Participation in another experimental drug study within four weeks prior to the first day of study treatment.
* Requirement for any concomitant chemotherapeutic agent other than the study medication.
* Any investigator judgment that the individual would not be an appropriate study subject.
|
NCT_ID
NCT00432562
|
Study_NameA Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
| 5,293 |
Study Objectives
Patients will be divided into 2 groups, 30 each. Group A will receive sphenopalatine ganglion block via a gauze soaked in local anesthetic introduced in the 2 nostrils then by local anesthetic injected by a cannula into both nostrils. Group B will undergo the same procedure, but normal saline will be used instead of the local anesthetic.
Conditions: Postoperative Pain
Intervention / Treatment:
PROCEDURE: Sphenopalatine ganglion block using bupivacaine: xylocaine, PROCEDURE: Sphenopalatine ganglion block using normal saline
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Patients between 18 and 60 years undergoing maxillofacial surgeries
Exclusion Criteria:
* Patient refusal
* Patients with fracture nose
* Operation time of more than 4 hours
|
NCT_ID
NCT05854537
|
Study_NameSphenopalatine Ganglion Block in Maxillofacial Surgeries
| 15,809 |
Study Objectives
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
Conditions: Lung Tumor
Intervention / Treatment:
DRUG: IV Acetaminophen, DRUG: Saline Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* Any elective VATS patients with low probability of conversion to thoracotomy as determined by surgery.
* Ages 18 <= age <= 99
* American Society of Anesthesiologists Physical Status I-III, hemodynamically stable
* Male or female
Exclusion Criteria:
* Age less than 18.
* Patient refusal
* High probability of conversion to thoracotomy as determined by surgeon
* Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure is converted to thoracotomy, as thoracotomy is more invasive and will likely require additional analgesia such as neuraxial and regional anesthesia).
* Scheduled procedure of VATS Pleurodesis/decortication
* History of Interstitial Lung Disease
* Emergency case
* Known allergy/adverse reaction to acetaminophen, morphine, or fentanyl
* History of drug or alcohol abuse
* Patients on preoperative analgesic therapy within one week of surgery
* Contraindication to self administered morphine (unable to understand PCA)
* Need for postoperative mechanical ventilation
* Necessary major deviation for intraoperative study protocol as per the discretion of the intraoperative attending anesthesiologist
* History of congestive heart failure, renal failure, liver failure
* Pregnant or breastfeeding women
* Weight less than 51 kg
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NCT_ID
NCT01783236
|
Study_NameAnalgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery
| 9,953 |
Study Objectives
This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.
Conditions: Melanoma
Intervention / Treatment:
BIOLOGICAL: GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV (54). Patients with resectable stage IIB, IIC and III disease must have undergone surgical resection before participating in this study.
* Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter > or = 16 mm; Height > or = 8 mm or involvement of ciliary body with tumor.
* For all patients, pathology slides must be reviewed by the Pathology Department of Memorial Sloan-Kettering Cancer Center for confirmation of melanoma diagnosis.
* Patients must be HLA-A2 positive.
* Patients must weigh at least 25 kg to be eligible. Patients must be able to read the consent form and give informed consent. Parent or legal guardians of patients who are minors will sign the informed consent form.
* Patients must have a Karnofsky performance status of at least 80.
* LDH <= 2x upper limit of normal value; albumin >= 3.5 mg/dl. Creatinine <= 2mg/dl and AST <= 2- fold upper limit of normal.
* A CBC prior to vaccination with WBC >= 3000, platelets >= 100,000.
* A negative serum bHCG within 2 weeks of vaccination in women of childbearing age.
* Patients must be free of detectable brain metastases. (Brain MRI or CT pre-protocol)
Exclusion Criteria:
* Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks or nitrosourea chemotherapy within the previous 6 weeks. Patients must be fully recovered from any previous therapy or surgery.
* Patients may not have been previously immunized with vaccines containing tyrosinase or gp100, or peptides derived from tyrosinase or gp100.
* Creatinine > 2mg/dl (or history of Creatinine > 2 mg/dl) and AST >= 2 fold upper limit of normal.
* Any medical condition or use of medication (e.g., active autoimmune disease, immunodeficiency or corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators. Patients may not have taken systemic corticosteroids (orally or intravenously) within the previous 6 weeks. Inhaled or nasal steroids are permitted.
* Patients who have preexisting retinal or choroidal eye disease (except as outlined in section 5.1.1) will be excluded.
* Patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible.
* Pregnant women, women who are less than 3 months post-partum or women who are nursing are not eligible. Women of childbearing age and sexually active men must be using appropriate contraception during the course of this study and for 3 months following completion.
|
NCT_ID
NCT00580060
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Study_NameInjection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
| 5,954 |
Study Objectives
The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced transitional cell carcinoma in terms of response rate and overall survival.
Conditions: Transitional Cell Carcinoma
Intervention / Treatment:
DRUG: Paclitaxel, Cisplatin, 5-Fluorouracil
Location: Taiwan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC
* Measurable disease
* Age>18
* KPS>60﹪
* Creatinine clearance>35ml/min,
* AST/ALT < or = 3.5times upper limits of normal reference values
* Bilirubin< or = 2.0 mg/dl
* WBC > or = 4,000/mm3, PLT > or = 100,000/mm3
* Written informed consent
Exclusion Criteria:
* Previous systemic chemo is not allowed
* TG <70mg/dl
* CNS metastasis
* Life expectancy less than 3 months
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NCT_ID
NCT00154687
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Study_NameWeekly TP-HDFL in the Treatment of Advanced TCC
| 18,727 |
Study Objectives
The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of K-BASKET trial.
Conditions: Solid Tumor, Adult
Intervention / Treatment:
DRUG: TAS-117
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration
* Progressive disease who failed to previous standard treatment.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
* Eastern Cooperative Oncology Group performance status 0 or 1
* Able to take medications orally
* Adequate organ function
* A life expectancy of at least 60 days
Exclusion Criteria:
* Previous treatment with anti-PI3K or AKT directed therapies
* Known hypersensitivity to any drugs similar to TAS-117 in structure or class.
* History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
* Current evidence of retinopathy that requires ophthalmological therapy.
* History or current evidence of cardiac arrhythmia and/or conduction abnormality.
* Treatment with any of the following within the specified time frame prior to study drug administration:
* Major surgery within prior 4 weeks
* Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration.
* Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks).
* A serious illness or medical condition(s)
* Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia).
* Patients with the risk of hypokalemia
* Receiving oral steroid medication.
* Pregnant or lactating female
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NCT_ID
NCT03017521
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Study_NameK-BASKET, TAS-117, PI3K/AKT Gene Aberration
| 16,269 |
Study Objectives
To assess if targeting activating EGFR and HER2 mutations in Non-Small Cell Lung Cancer (NSCLC) is more effective when these mutations are truncal dominant mutations (≥50%), as opposed to non-dominant (≥5 to \<50%) or low frequency mutations (\<5%).
This trial will be available to patients registered to the TRACERx study (NCT01888601), or non-TRACERx patients who have two archival tissue/DNA samples who are willing to have a biopsy of their relapsed disease.
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: Afatinib
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Subjects must be willing to have a biopsy of relapsed disease. Consent will be obtained through the TRACERx study or with the 'trial entry tissue collection' consent form(non-TRACERx patients). Procurement of the biopsy sample is not necessary at the time of trial registration. However, patients must undergo a biopsy prior to commencement of afatinib.
* Patients must have tumours harbouring a sensitising EGFR mutation or HER2 mutation in at least one biopsy at recurrence, or region of the primary sample.
* Non-TRACERx patients must have at least two archival tissue/DNA samples of their disease available.
* Written informed consent for DARWIN1.
* ECOG performance status 0 <= age <= 3
* No previous exposure to an EGFR TKI (other than afatinib) or HER2 targeted therapy
* Measurable disease by RECIST v1.1. Patients without measurable disease may be eligible following discussion with the CI and UCL CTC but will not count towards the primary PFS endpoint.
* At least 18 years.
* Anticipated life expectancy of at least three months.
* Adequate organ function as defined by the following baseline values:
* Absolute neutrophil count (ANC) >=1.5x109/L
* Platelets >=100x109/L
* Serum bilirubin <=1.5 x upper limit of normal (ULN). In patients with known Gilbert's syndrome, total bilirubin <=3xULN with direct bilirubin <=1.5xULN
* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) <=3xULN or <=5x ULN if liver metastases are present
* Creatinine clearance must be >=30mL/min
* Women with child-bearing potential, or men who are able to father a child, must be willing to practice highly effective methods of contraception during the trial and for 1 month after the end of treatment.
* Women of childbearing potential must have a negative pregnancy test within 14 days before the first dose of trial medication.
Exclusion Criteria:
* Currently suitable for radical radiotherapy.
* Requirement for intravenous feeding, active peptic ulcer, prior surgical procedures affecting absorption or any medical comorbidity affecting gastrointestinal absorption.
* Patients with current or pre-existing interstitial lung disease.
* Significant or recent acute gastrointestinal abnormalities with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption, or CTCAE v4.03 Grade >=3 diarrhoea of any etiology at baseline.
* Known hypersensitivity to afatinib or to any of the excipients.
* Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
* Women of childbearing potential, or men who are able to father a child, unwilling to use a highly effective method of contraception during the trial.
* Anti-cancer therapy including chemotherapy, immunotherapy, biologic therapy, or major surgery within 14 days prior to start of trial therapy.
* Known human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection. Subjects with evidence of hepatitis B virus clearance may be enrolled.
* History of other malignancy; Exception: (a) Subjects who have been successfully treated and are disease-free for 3 years, (b) a history of completely resected non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission, or (e) indolent prostate cancer requiring no or only anti-hormonal therapy with histologically confirmed tumor lesions that can be clearly differentiated from lung cancer target and non-target lesions are eligible.
* The following cardiac abnormalities:
* Corrected QT (QTc) interval >=480 msecs
* History of acute coronary syndromes (including unstable angina) within the past 24 weeks
* Coronary angioplasty, or stenting within the past 24 weeks
* Class III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
* History of known arrhythmias (except sinus arrhythmia) within the past 24 weeks
* Myocardial infarction within the last 6 months
* Uncontrolled medical conditions (i.e., diabetes mellitus, hypertension etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to comply with the requirements of the trial, trial protocol or to provide informed consent.
* Pregnant, lactating or actively breastfeeding females.
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NCT_ID
NCT02183883
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Study_NameDeciphering Afatinib Response and Resistance With INtratumour Heterogeneity
| 18,548 |
Study Objectives
The purpose of this study is to evaluate the effectiveness of a device that delivers freezing temperature compared to injecting lidocaine (an anesthetic medication) in providing pain relief to patients with disorganized nerve bundle between the toes, also known as Morton's neuroma. The same ultrasound technology that the obstetricians use to visualize a fetus inside a pregnant woman will be used to help the study physician to locate the Morton's neuroma while precisely delivering the freezing temperature and lidocaine near the nerve.
Conditions: Intermetatarsal Neuroma
Intervention / Treatment:
DEVICE: Cryoablation, DRUG: Lidocaine, DRUG: Saline
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: SINGLE
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Inclusion Criteria:
* Between the ages of 18 and 80 years
* Magnetic Resonance Imaging (MRI) confirmed diagnosis of Morton's neuroma - Refractory (greater than 3 month) symptoms to multiple conservative management, including physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDS) and foot orthotics.
* No history of systemic inflammatory conditions such as rheumatoid arthritis
* Able to give written informed consent - Subject has been on a stable dose of analgesic mediation (or not on analgesic medication) for at least 3 weeks and is agreeable to remaining on current regimen for the duration of the study.
Exclusion Criteria:
* Diagnosed complex regional pain syndrome (CRPS)
* Pregnancy - History of intolerance, hypersensitivity or known allergy to lidocaine - Recent history of recent surgical intermetatarsal neuronectomy (within previous 6 months) - Coagulation disorder - Current infection
* Intermetatarsal bursitis
* Metatarsophalangeal joint instability/capsulitis
* Metatarsal stress fracture
* Lumbar radiculopathy
* Tarsal tunnel syndrome
* Frieberg's infraction
* Painful callosities associated with toe deformities
* Peripheral neuropathy
* Diabetes mellitus and peripheral vascular diseases
* Insufficient command of English to complete self-¬report instruments.
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NCT_ID
NCT02838758
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Study_NameCompare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma
| 4,450 |
Study Objectives
This phase II trial studies how well sorafenib tosylate works in treating younger patients with relapsed or refractory rhabdomyosarcoma, Wilms tumor, liver cancer, or thyroid cancer. Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Conditions: Childhood Hepatocellular Carcinoma, Papillary Thyroid Cancer, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Rhabdomyosarcoma, Recurrent Thyroid Cancer, Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Intervention / Treatment:
DRUG: sorafenib tosylate, OTHER: pharmacological study, OTHER: laboratory biomarker analysis
Location: Canada, United States, Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse:
* Rhabdomyosarcoma (RMS)
* Wilms tumor
* Hepatocellular carcinoma (HCC)
* Papillary thyroid carcinoma (PTC)
* Patients must have relapsed or refractory disease (RMS, Wilms tumor, HCC, PTC)
* Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
* The following do not qualify as measurable disease:
* Malignant fluid collections (e.g., ascites, pleural effusions)
* Bone marrow infiltration
* Lesions only detected by nuclear medicine studies (e.g., bone, gallium, or positron emission tomography [PET] scans)
* Elevated tumor markers in plasma or cerebrospinal fluid(CSF)
* Previously radiated lesions that have not demonstrated clear progression post radiation
* Leptomeningeal lesions that do not meet the requirements noted above
* Patients with HCC must be relapsed or refractory to conventional chemotherapy
* Patients with PTC must be refractory to radioactive iodine (RAI)
* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
* Patients with known metastasis to the brain will be excluded from trial participation unless treated surgically or with radiotherapy and stable with no recurrent lesions for at least 3 months
* Rhabdomyosarcoma and Wilms strata: patients must be >= 24 months and <= 30 years at study enrollment
* Hepatocellular carcinoma (HCC): patients must be >= 24 months and < 18 years at study enrollment
* Papillary thyroid carcinoma (PTC): patients must be >= 24 months and <= 21 years at study enrollment
* Patients must have a Lansky or Karnofsky performance status score of >= 50%, corresponding to ECOG categories 0, 1, or 2
* Use Karnofsky for patients > 16 years and Lansky for patients <= 16 years
* Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* Peripheral absolute neutrophil count (ANC) >= 1,000/μL
* Platelet count >= 75,000/μL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
* Hemoglobin 8.0 g/dL (may receive red blood cell[RBC] transfusions)
* Creatinine clearance or radioisotope glomerular filtration rate(GFR) 70 mL/min OR a serum creatinine based on age/gender as follows:
* 0.8 mg/dL (2 to < 6 years)
* 1.0 mg/dL (6 to < 10 years)
* 1.2 mg/dL (10 to < 13 years)
* 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years)
* 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years)
* Total bilirubin <= 1.5 times upper limit of normal (ULN) for age
* SGPT (ALT) <= 135 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)
* PT, PTT, and INR < 1.5 times ULN
* Normal serum lipase and amylase (per institutional normal values)
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination
* A blood pressure (BP) <= the 95^th percentile for age, height, and gender; and not receiving medication for treatment of hypertension
* Patients who are pregnant or breast-feeding are not eligible
* Negative pregnancy tests must be obtained in girls who are post-menarchal
* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method beginning at the signing of the informed consent until at least 30 days after the last dose of the study drug
* Patients with clinical symptoms of hepatic encephalopathy or ascites are not eligible
* Patients who have an uncontrolled infection are not eligible
* Patients with evidence of bleeding diathesis are not eligible
* Patients with known Gilbert syndrome are not eligible
* Patients who, in the opinion of the investigator, may not be able to comply with the safety-monitoring requirements of the study are not eligible
* No concurrent chemotherapy, radiation therapy, immunomodulating agents, or other investigational agents
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
* At least 7 days must have elapsed since the completion of therapy with a growth factor (at least 14 days must have elapsed after receiving pegfilgrastim)
* At least 7 days must have elapsed since completion of therapy with a biologic agent;
* For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur
* At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody
* At least 2 weeks must have elapsed since local palliative radiotherapy (XRT) (small port); >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if TBI was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given
* No evidence of active graft-vs-host disease and >= 2 months must have elapsed since transplant (stem cell transplant or rescue without total-body irradiation)
* For patients with papillary thyroid carcinoma (PTC) only: >= 3 weeks from prior radioiodine (RAI) treatment
* Patients requiring corticosteroids that have not been on a stable or decreasing dose of corticosteroid for 7 days prior to enrollment are not eligible
* Patients who are currently receiving another investigational drug are not eligible
* Patients who are currently receiving other anti-cancer agents are not eligible
* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post transplant are not eligible for this trial
* Patients who take cytochrome P450 enzyme-inducing anti-epileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, grapefruit juice, or St. Johns wort will not be eligible for the trial
* Patients who have received prior treatment with sorafenib are not eligible
* Patients must not be on therapeutic anti-coagulation;
* Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial devices is allowed provided that the requirements for prothrombin time(PT), partial thromboplastin time(PTT), and international normalized ratio(INR) are met
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NCT_ID
NCT01502410
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Study_NameSorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer
| 13,701 |
Study Objectives
The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.
Conditions: HER2 Positive Metastatic Breast Cancers
Intervention / Treatment:
DRUG: Tucatinib, DRUG: Capecitabine, DRUG: Trastuzumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria
* Metastatic breast cancer, documented as HER2+ by fluorescence in situ hybridization (FISH) and/or 3+ staining by immunohistochemistry (IHC).
* Progressive disease, with a history of prior treatment with both trastuzumab and T-DM1 (unless deemed intolerant to or ineligible for T-DM1 by the investigator) for metastatic disease.
* If female and of child-bearing potential, has negative pregnancy test within 14 days prior to treatment.
* If a sexually active male or a sexually active female of child-bearing potential, agrees to use dual (two concurrent) forms of medically accepted contraception from the time of consent until 6 months after the last dose of ONT-380, capecitabine, or trastuzumab, whichever is longest.
* Must have target or non-target lesions as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
* All toxicity related to prior cancer therapies must have resolved to <= Grade 1, with the following exceptions: alopecia; neuropathy, which must have resolved to <= Grade 2; and congestive heart failure (CHF), which must have been <= Grade 1 in severity at the time of occurrence and must have resolved completely.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
* In the opinion of the Investigator, life expectancy > 6 months.
* Adequate hematologic function as defined by:
1. Hemoglobin >= 9 g/dL
2. Absolute neutrophil count (ANC) >= 1000 cells/μL
3. Platelets >= 100,000/μL
* Adequate hepatic function as defined by the following:
1. Total bilirubin <= 1.5 X upper limit of normal (ULN), unless a known history of Gilbert's disease
2. Transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] and alanine aminotransferase/serum glutamic pyruvic transaminase [ALT/SGPT]) <= 2.5 X ULN (< 5 X ULN if liver metastases are present)
* International normalized ratio (INR) and activated partial thromboplastin time (aPTT) <= 1.5 X ULN unless on medication known to alter INR and aPTT.
* Creatinine clearance >= 50 mL/min.
* Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 4 weeks prior to first dose of study drug.
Exclusion Criteria
* Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
* Patient is breastfeeding.
* Previous treatment with any experimental agent within 14 days or five half-lives of study treatment, whichever is greater.
* Previous treatment with trastuzumab or other antibody-based therapy within three weeks of starting study treatment or with chemotherapy or hormonal cancer therapy within two weeks of starting study treatment.
* Previous treatment with cumulative dose of doxorubicin > 360 mg/m2 or previous treatment with another anthracycline with cumulative dose equivalent to > 360 mg/m2 doxorubicin.
* Previous treatment with:
1. Capecitabine for metastatic disease at any time, for patients assigned to cohorts using capecitabine plus ONT-380 (Combination 1) or capecitabine plus trastuzumab plus ONT-380 (Combination 3). However, patients who have previous treatment with capecitabine for metastatic disease are eligible for enrollment into cohorts using trastuzumab plus ONT-380 (Combination 2). Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible to enroll into all cohorts (Combination 1, 2, or 3).
2. Any small molecule HER2 inhibitors including (but not limited to) lapatinib, neratinib, or afatinib within the last 4 weeks prior to initiation of study therapy.
* CNS disease:
1. Patients with leptomeningeal disease are excluded.
2. Dose escalation and expansion cohorts: Patients with symptomatic CNS metastases are excluded. Patients with treated CNS metastases or untreated asymptomatic CNS metastases not requiring immediate local therapy may be eligible. Enrollment of patients with metastases must be approved by the study medical monitor.
3. Optional CNS disease expansion cohorts: Patients with untreated asymptomatic CNS metastases not requiring immediate local therapy or patients with progressive CNS disease following local therapy may be eligible with medical monitor approval.
* History of allergic reactions to compounds of similar chemical or biological composition to capecitabine (for patients assigned to Combination 1 or 3 only), trastuzumab (for patients assigned to Combination 2 or 3 only), or ONT-380, except for a history of Grade 1 or Grade 2 Infusion Related Reaction to trastuzumab, which has been successfully managed.
* Patients with uncorrectable electrolyte abnormalities.
* Known to be HIV positive. HIV testing is not required for those patients who are not known to be positive.
* Known carrier of Hepatitis B and / or Hepatitis C (whether active disease or not).
* Known liver disease, autoimmune hepatitis, or sclerosing cholangitis.
* Inability to swallow pills or any significant gastrointestinal diseases, which would preclude adequate absorption of oral medications.
* Use of a strong CYP3A4 inhibitor or inducer within three elimination half-lives of the inhibitor or inducer prior to the start of study treatment.
* Use of a strong CYP2C8 inducer or inhibitor within three elimination half-lives of the inducer or inhibitor prior to the start of study treatment. (See Appendix F).
* Radiotherapy within 14 days of first dose of ONT-380; patient must have recovered from acute effects of radiotherapy to baseline.
* Known impaired cardiac function or clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, congestive heart failure, and uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
* Myocardial infarction or unstable angina within 6 months prior to the first dose of study drug.
* Patient with known dihydropyrimidine dehydrogenase deficiency (for patients assigned to Combination 1 or 3 only).
* Patient requiring warfarin therapy with known history of difficulty in management of maintaining INR within therapeutic range. Patients on warfarin may be included if on a stable dose with a therapeutic INR.
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NCT_ID
NCT02025192
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Study_NameA Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer
| 5,076 |
Study Objectives
This study will be performed on grade IIIb and grade IV Non Small Cell Lung Cancer (NSCLC) chemotherapy naive patients with good performance status. In course of this study, patients will be treated with Paclitaxel in combination with either Cisplatin or Carboplatin in a maximum of six therapy cycles. The goal of this study is to determine, if a pharmakokinetic driven dose adaptation of paclitaxel leads to a reduction of of grade 4 neutropenia, compared to conventional Paclitaxel dosing, without affecting progression free survival and overall survival.
This study includes a biomarker analysis and an optional genetic substudy.
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: Paclitaxel dosing according to SmPC, DRUG: Individualized pharmacokinetically driven paclitaxel dosing
Location: Germany, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Capable of understanding the protocol requirements and risks, and providing written informed consent.
* Patients with histologically confirmed NSCLC (stage IIIB-IV).
* Patients considered for first-line palliative chemotherapy with paclitaxel in combination with either cisplatin or carboplatin. Patients having received prior adjuvant non taxane-containing adjuvant chemotherapy are eligible.
* At least one bidimensionally measurable lesion according to RECIST 1.1.
* ECOG Performance Status (ECOG-PS) status <= 2.
* Female or male patients of 18 <= age <= 75 of age at randomization
* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods (condom).
* An absolute neutrophil count >1,500 cells/ mm3 (= 1.5 G/l).
* Platelet count > 100,000/mm3.
* Total bilirubin <= 2 x upper limit of normal.
* AST and ALT <= 2.5 x upper limit of normal, or <= 5 x upper limit of normal in case of liver metastases.
* Creatinine clearance (according to the Cockcroft-Gault formula) >=30ml/min. For patients planned to receive Cisplatin: Creatinine clearance >=60ml/min.
* Patients suffering from asymptomatic brain metastases can be enrolled in case corticosteroid therapy is not indicated. Prior irradiation must be completed at least 4 weeks prior to first cycle of treatment.
Exclusion Criteria:
* Serious concomitant systemic disorders (e.g., active infection, severe heart disease, uncontrolled hypertension or diabetes mellitus) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
* A history of hypersensitivity reactions to drugs formulated in polyoxyethylated castor oil.
* Having received prior treatment with paclitaxel or cisplatin or carboplatin (other drugs/drug combinations are allowed).
* Concomitant treatment with any targeted drug (licensed or experimental) like bevacizumab or cetuximab.
* Any condition / concomitant disease not allowing chemotherapy with paclitaxel, the platinum compound (carboplatin or cisplatin) or required premedication for the treatment regimen.
* Pregnant/nursing women.
* Individuals known to be seropositive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen or syphilis.
* Treatment with cytotoxic or biologic agents or any experimental drug within the 4 weeks prior to beginning treatment on this study.
* Secondary malignancy within the last five years, with the exception of adequately treated carcinoma-in-situ of the uterine cervix, basal-cell carcinoma of the skin and pTa or pTis urothelial cancer.
* Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
* Preexisting neuropathy > grade I NCI-CTC.
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NCT_ID
NCT01326767
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Study_NameCentral European Society for Anticancer Research (CESAR) Study of Paclitaxel Therapeutic Drug Monitoring
| 9,593 |
Study Objectives
Local thermal ablation therapy of tumor is a rapidly developing minimally invasive therapy for lung tumors in recent years. This study evaluated the efficacy of thoracic paravertebral block (TPVB) for anaesthesia during ablation surgery of lung tumor.
Conditions: Lung Cancer
Intervention / Treatment:
OTHER: Ropivacaine
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion criteria
* Patients diagnosed with lung cancer by imaging examination
* Informed consent of the patient and study approval by the Medical Ethics Committee
Exclusion criteria
* have a history of psychiatric illness, chronic pain, regular analgesic usage
* have contraindications to performing a TPVB, such as chest wall deformity, severe coagulopathy, local infection
* have allergy to local anaesthetic drugs
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NCT_ID
NCT05437718
|
Study_NameApplication of Ultrasound-Guided Thoracic Paravertebral Block in Pulmonary Ablation Surgery
| 7,889 |
Study Objectives
Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels. The genetically determined cause of the PCOS includes disturbed levels of insulin and androgens. Standardized fenugreek seed extract (Furocyst) contains compounds such as saponins \& flavonoids which act on the insulin and indirectly helps to regulate the androgen levels in the body.
Conditions: Poly Cystic Ovary Syndrome
Intervention / Treatment:
DIETARY_SUPPLEMENT: Fenugreek seeds extract 500 mg
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Premenopausal women between 18 <= age <= 45 years and BMI less than 42
* Diagnosed with PCOS
* Adequate hepatic, renal and hematological functions
* Patients willing to give informed consent in writing
Exclusion Criteria:
* Males
* Post menopausal women
* Women with hysterectomy
* Patients with congenital adrenal hyperplasia
* Patients suffering from Cushing's syndrome
* Patients diagnosed with androgen secreting tumors
* Patients with thyroid dysfunction (T3, T4 level is higher than that in normal women of reproductive age)
* Patients with Hypo-gonadotropic and Hypo-gonadism (central origin of ovarian dysfunction)
* Pregnancy or desire for pregnancy or lactating mothers
|
NCT_ID
NCT02789488
|
Study_NameClinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome
| 18,198 |
Study Objectives
The goal of this clinical research study is to compare pazopanib to temsirolimus in the treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be studied.
Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.
Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.
This is an investigational study. Pazopanib and temsirolimus are both FDA approved and commercially available for the treatment of kidney cancer. It is investigational to compare the 2 drugs.
Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Conditions: Kidney Cancer
Intervention / Treatment:
DRUG: Pazopanib, DRUG: Temsirolimus, BEHAVIORAL: Quality of Life Assessment, DRUG: Benadryl
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* Pathologic confirmation of metastatic or locally advanced RCC with a major clear cell component.
* Measurable disease by RECIST criteria.
* Age >= 18 years
* ECOG performance status 0 <= age <= 2 or Karnofsky Performance Status >= 60%
* Meets criteria for poor-risk defined as 3 or more of the following: ECOG performance status 2, anemia (hemoglobin lower than reference range), elevated serum LDH > 1.5x upper limit of normal (ULN), hypercalcemia (corrected serum calcium level > upper limit of normal), time from initial RCC diagnosis to registration on this trial < 1 year, and > 1 metastatic organ sites.
* Adequate organ and marrow function within 14 days of registration as defined below: a) Absolute neutrophil count >=1,500/µL b) Platelets >=100,000/µL c) Hgb >= 9.0 g/dL (transfusion allowed) d) Renal: serum creatinine <= 1.5 x ULN or calculated CrCl >= 40 cc/min and random urine protein:creatinine ratio (UPC) < 1 or 24-hr urine protein < 1g e) Liver: total bilirubin <= 1.5 mg/dl; AST (SGOT) and ALT (SGPT) <= 2.5 x ULN for subjects without evidence of liver metastases, <= 5 x ULN for subjects with documented liver metastases f) INR <= 1.2 x ULN; PTT <= 1.5 x ULN. Therapeutic anticoagulation with warfarin is allowed if target INR <= 3 on a stable dose of warfarin or on a stable dose of LMW heparin for > 2 weeks (14 days) at time of randomization.
* Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test within 14 days of study registration. Pregnancy test must be repeated if performed > 14 days before starting study drug.
Exclusion Criteria:
* Prior malignancy, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years
* Prior targeted therapy (anti-VEGF agents or mTOR inhibitors) including adjuvant therapy, and prior chemotherapy for mRCC. However, prior immunotherapy (cytokines or vaccines) is allowed.
* Any experimental drug while on this study; however, concomitant bone targeted therapy (bisphosphonates or the anti-RANK ligand denosumab) is allowed.
* Uncontrolled brain metastases and infections. Patients with brain metastases treated with Gamma Knife (GK) or whole brain radiation within 24 hours of registration.
* History of stroke within 6 months of registration
* Clinically significant cardiovascular disease, defined as myocardial infarction (or unstable angina) within 6 months of registration, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia refractory to medical management. However, treated and controlled or stable/not clinically significant cardiovascular disease is allowed per evaluation by cardiologist.
* Uncontrolled hypertension (home blood pressure readings are permitted) or prior history of hypertensive crisis or hypertensive encephalopathy; however, treatment of hypertension with medications is permitted.
* History of uncontrolled hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
* Significant vascular disease including aortic aneurysm, aortic dissection.
* Symptomatic peripheral vascular disease
* Pregnancy
* HIV-positive patients receiving combination anti-retroviral therapy
* Coagulopathy or bleeding diathesis
* Concomitant treatment with rifampin, St. John's wort, or the cytochrome p450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital)
* Major surgery within 28 days prior to registration
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device within 7 days prior to starting drug
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration
* Serious non-healing wound
* Baseline QTcB >= 470 msec.
|
NCT_ID
NCT01392183
|
Study_NamePazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)
| 19,845 |
Study Objectives
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
DRUG: dovitinib, DRUG: sorafenib
Location: Thailand, Singapore, Taiwan, Japan, China, Korea, Republic of, Hong Kong
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines
* Advance HCC Stage B and C according to BCLC staging classification
* Child Pugh A
* At least one measurable lesion as assessed by CT or MRI
* ECOG PS of 0 or 1
* Adequate bone marrow, liver, and renal function
Exclusion Criteria:
* Prior systemic therapy for HCC
* Brain metastases
* Active bleeding (including variceal bleeding as the result of esophageal varices) Patients who have received a liver transplant or are awaiting an immediate transplant
Other protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT01232296
|
Study_NameA Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
| 6,835 |
Study Objectives
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.
This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.
Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.
Conditions: Non-Hodgkin's Lymphoma, Diffuse Large Cell Lymphoma, Mantle Cell Lymphoma, Transformed Lymphoma, Other Subtypes of B-cell Lymphoma, Lymphoma
Intervention / Treatment:
DRUG: Rituximab 375 mg/m2
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* B-cell, CD20+ NHL
* Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Creatinine < 2 mg/dL
* Bilirubin < 2.0 mg/dL
* Liver function tests (LFTs) < 5 x upper limit of normal (ULN)
Exclusion Criteria:
* Graft source from bone marrow
* Non-responders [progressive disease (PD) or stable disease (SD)] to prior anti-CD20 therapy
* PD after ASCT
* Post-ASCT radiotherapy
* Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab
* Evidence of active pneumonitis
* Evidence of active infection
* Concurrent prednisone or other systemic steroid medication
* Nitrosourea therapy within 6 weeks of the first treatment with rituximab
* Presence of anti-murine antibody (HAMA) reactivity
|
NCT_ID
NCT00225212
|
Study_NameRituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
| 9,363 |
Study Objectives
The purpose of this study is to test the safety of certolizumab when it is given with the chemotherapy drugs cisplatin and pemetrexed. Cisplatin and pemetrexed are two chemotherapy drugs used in the treatment of lung cancer. The investigators want to find out what effects, good and/or bad, certolizumab has on the patient and lung cancer.
Conditions: Stage IV Lung Adenocarcinoma
Intervention / Treatment:
DRUG: Certolizumab, DRUG: cisplatin, DRUG: pemetrexed
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Previously untreated stage IV lung adenocarcinoma confirmed at MSKCC
* Age >= 18 years
* Karnofsky Performance Status >= 70
* Patients with locally treated, stable, and/or asymptomatic brain metastases are eligible.
* Adequate bone marrow, liver and renal function, as specified below:
* Absolute Neutrophil Count (ANC) >= 1.5 x 109/L
* Hemoglobin >= 8 g/dL
* Platelets >= 100 x 109/L
* Serum total bilirubin <= 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)
* AST and ALT <= 2.5 x ULN or <= 5 x ULN if liver metastases are present
* Serum creatinine <= 1.5 x upper limit of normal or creatinine clearance >= 60ml/min for patients with creatinine levels above institutional normal.
* Negative PPD test
* For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
* Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
* Presence of at least one site of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors
* Archival tissue (10 Unstained Slides - 5 micron sections) from a core biopsy performed and received within 30 days before signing consent or ability to have a fresh core biopsy performed
* Biopsy cannot be from any cytology or bone specimen
* Biopsy site must be amenable to re-biopsy at the end of the study
* Ability to provide written, informed consent
Exclusion Criteria:
* Hypersensitivity to platinum agents
* Ongoing use of investigational agents or use of investigational agents within the last four weeks
* Prior use of agents for TNF-alpha blockade
* History of rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritis
* Baseline hearing deficit (CTCAE version 4.0 grade 2 or higher)
* Ongoing bacterial, viral, or antifungal infection requiring antimicrobial treatment with the exception of thrush
* Active tuberculosis or untreated, latent tuberculosis
o If a patient has signs, symptoms, or a history suggestive of active tuberculosis, evaluation by an infectious disease physician will be required and active tuberculosis ruled-out prior to enrollment.
* Acute or chronic Hepatitis B or C infection
* Known HIV infection requiring antiretroviral medications and those with AIDS
* Active herpes zoster infection
* Non-healed infected skin ulcers
* History of myocardial infarction or unstable angina within the past 12 months
* Ongoing use of other immunosuppressive medications, including oral steroids and excluding topical steroids
* Women who are breastfeeding Prior history of other malignancy with the exclusion of localized prostate cancer, non-melanomatous skin cancer, ductal carcinoma or lobular carcinoma in situ of the breast
|
NCT_ID
NCT02120807
|
Study_NameCertolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas
| 17,666 |
Study Objectives
To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and percutaneous iodine-125 (125I) seeds implantation results in better survival compared with use of RFA alone in patients with hepatocellular carcinoma.
Conditions: Liver Carcinoma
Intervention / Treatment:
PROCEDURE: Radiofrequency Ablation, RADIATION: iodine
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE
|
Inclusion Criteria:
(a) age 18 <= age <= 75 years and refusal to undergo surgery; (b) a solitary HCC 7.0 cm in diameter or smaller or multiple (up to three) HCCs 3.0 cm in diameter or smaller; (c) lesions visible at ultrasonography (US), with an acceptable and safe path between the lesion and the skin seen on the US scan; (d) no extrahepatic metastasis; (e) no imaging evidence of tumor invasion into the major portal or hepatic vein branches; (f) no history of encephalopathy, ascites refractory to diuretics, or variceal bleeding; (g) a platelet count of more than 40 000 cells/mm3 and (h) no previous treatment for HCC except liver resection.
Exclusion Criteria:
Exclusion criteria included active thyroid disease, serious concurrent medical illnesses, extrahepatic diseases, previous anticancer treatment before surgery, histologically proved non-HCC tumors and women who were pregnant or breastfeeding.
|
NCT_ID
NCT01717729
|
Study_NameHepatocellular Carcinoma Treated With Iodine-125 Implantation
| 5,359 |
Study Objectives
This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.
Conditions: Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Pemetrexed, DRUG: Cisplatin, DRUG: Placebo, DRUG: Pemetrexed, OTHER: Best Supportive Care
Location: Poland, Germany, Portugal, Spain, United Kingdom, Australia, Italy, Netherlands, Belgium, Greece, Turkey, Romania, France, Finland, India
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria for the Induction Phase:
* You must sign an informed consent document for clinical research.
* You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.
* You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
* You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss).
* You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan.
* Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory.
* You must be 18 years or older.
* Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy).
Exclusion Criteria for the Induction Phase:
* You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer
* You cannot have received other investigational drugs within the last 30 days of entering the trial.
* You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed.
* You cannot have other serious on-going illnesses including active infections.
* You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.
* You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago.
* You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis.
* You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment).
* You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
* You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination.
* You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs).
* You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.
* You cannot be pregnant or breastfeeding.
Inclusion criteria at Randomization for the Maintenance Phase:
* You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
* You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized to the maintenance phase.
|
NCT_ID
NCT00789373
|
Study_NameA Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer
| 1,277 |
Study Objectives
The purpose of this research study is to determine the safest and most effective dose of 5-FU that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be studying the toxicity of this regimen of 4 drugs and the tumor response.
Conditions: Head and Neck Neoplasms
Intervention / Treatment:
DRUG: Cetuximab, DRUG: Docetaxel, DRUG: Cisplatin, DRUG: 5-Fluorouracil
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically proven squamous cell carcinoma of the head and neck.
* Primary tumor sites eligible: oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx. Unknown primary SCC will also be eligible.
* Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound or CAT scan.
* At lease one uni- or bi-dimensionally measurable lesion by RECIST criteria.
* 18 years or older
* ECOG performance status of 0 <= age <= 1
* Adequate bone marrow, hepatic and renal functions as outlined in the protocol.
Exclusion Criteria:
* Pregnant or breast feeding women
* Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
* Symptomatic peripheral neuropathy greater or equal to grade 2
* Symptomatic altered hearing > grade 2 by CIT-CTC criteria
* Unstable cardiac disease despite treatment, myocardial infarction within 6 months
* History of significant neurologic or psychiatric disorders including dementia or seizures
* Active clinically significant uncontrolled infection
* Active peptic ulcer disease defined as unhealed or clinically active
* Hypercalcemia
* Active drug addiction, including alcohol, cocaine or intravenous drugs use
* Chronic Obstructive Pulmonary Disease
* Autoimmune disease requiring therapy, prior organ transplant, or HIV infection
* Interstitial lung disease
* Involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
* Concurrent treatment with any other cancer drug
* Prior EGFR therapy
* Prior severe infusion reaction to antibody therapy
* Participation in an investigational trial within 30 days of study entry
|
NCT_ID
NCT00402545
|
Study_NameC-TPF in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck
| 20,623 |
Study Objectives
The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia.
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Dexamethasone, DRUG: Cytarabine, DRUG: Methotrexate, DRUG: Rituximab, DRUG: 6-Mercaptopurine, DRUG: Prednisone, DRUG: L-asparaginase
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Diagnosis of CD20-positive ALL
* Adequate liver function (bilirubin less than or equal to 1.5*ULN, unless considered due to tumor), and renal function (creatinine less than or equal to 1.5*ULN, unless considered due to tumor)
* Signed informed consent
Exclusion Criteria:
* Prior history of treatment with high-dose Ara-C, MTX or rituximab
* Pregnant or lactating women
* History of allergy to rituximab
* Unable to sign informed consent
* Active replication of HBV
* History of stem cell transplantation
|
NCT_ID
NCT01358253
|
Study_NameRituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
| 22,107 |
Study Objectives
A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.
Conditions: Febrile Neutropenia, Hematological Malignancy
Intervention / Treatment:
DRUG: Discontinuation of imipenem-cilastatin or meropenem
Location: Netherlands
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
* High-risk neutropenia (Absolute neutrophil count (ANC) <0.5x109/L which is expected to last longer than 7 days);
* Fever (One single measured tympanic membrane temperature of >38.5°C or a temperature of >38.0°C during 2 subsequent measurements separated by at least 2 hours);
* Age >= 18 years;
* Written informed consent.
Exclusion Criteria:
* Contraindications to use of imipenem-cilastatin or meropenem such as allergy, previous severe side-effects or previous microbiological cultures with carbapenem-resistant microorganism(s).
* Corticosteroid use >=10 mg per day prednisolone or equivalent for more than 3 consecutive day during the previous 7 days.
* Clinically or microbiologically documented infection.
* Symptoms of septic shock (systolic blood pressure <90 mm Hg unresponsive to fluid resuscitation and/or oliguria (urine production <500mL/day).
* Previous enrollment in this study during the same episode of neutropenia.
* Any critical illness for which Intensive Care Unit treatment is required.
* Legal incompetency
|
NCT_ID
NCT02149329
|
Study_NameShort Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO
| 4,955 |
Study Objectives
RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib.
PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: Sorafenib, DRUG: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC)
* Disease must have progressed after at least 2 prior chemotherapy regimens for NSCLC
* Patients must have measurable or nonmeasurable disease
* Absolute neutrophil count at least 1,500/mm^3
* Platelet count at least 100,000/mm^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 3 times ULN (5 times ULN in patients with liver disease)
* Creatinine less than 1.5 times ULN or calculated creatinine clearance greater than 50 mL/min
* More than 3 weeks since prior chemotherapy, radiotherapy, immunotherapy or other investigational drug use
* Recovered from all prior therapy
* Fertile patients must use effective contraception
* Age >= 18
* ECOG performance status of 0 <= age <= 1
Exclusion Criteria:
* Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable and off therapy for at least 2 months
* Active second malignancy
* Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms of coronary heart disease
* Prior radiotherapy to the only site of measurable or evaluable disease unless there is evidence of disease progression in that site
* Prior exposure to a ras pathway inhibitor (e.g., farnesyl transferase inhibitor)
* Concurrent medications known to be metabolized by the liver with a narrow therapeutic index, including the following:
* Ketoconazole
* Itraconazole
* Quinidine
* Digoxin
* Cyclosporine
* Ritonavir
* Grapefruit products
* Carbamazepine
* Phenytoin
* Phenobarbital
* Pregnant or nursing
* Clinically serious active infection
* Medical conditions, substance abuse or psychological/social situation that would preclude study participation
|
NCT_ID
NCT00064350
|
Study_NameSorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer
| 13,806 |
Study Objectives
Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.
Conditions: Thyroid Cancer
Intervention / Treatment:
DRUG: Irofulven + capecitabine
Location: Peru, Ukraine, United States, Russian Federation, France, Argentina
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* 18 years or older.
* Cancer of the thyroid confirmed by a biopsy sample. Specific types of thyroid cancer included in this study are anaplastic, differentiated (papillary, follicular, or Hürthle cell), and medullary thyroid cancers.
* For patients with differentiated (papillary, follicular, or Hürthle cell) thyroid cancer, no more than 1 prior chemotherapy treatment is allowed.
* Measurable disease is required (at least one lesion at least 2 cm in length by conventional computed tomography (CT) techniques or at least 1 cm by spiral CT scan).
* Any prior chemotherapy or radiation therapy must be stopped at least 4 weeks before the first dose of study treatment. Prior radioiodine (I131) therapy must be stopped at least 3 (or 6) months before first dose of study treatment (depending on responsiveness to this therapy).
* Recovery from any toxic effects of prior chemotherapy, radiation therapy and surgery.
* Patients with reproductive potential must use a medically acceptable contraceptive method. Women of childbearing potential must have a negative pregnancy test at screening.
Exclusion Criteria:
* History of retinopathy.
* Serious ongoing medical or psychiatric disorder (as determined by the clinical investigator).
* External beam radiation therapy to >30% of the bone marrow at any time prior to study entry.
* Prior treatment with irofulven or capecitabine, or protracted infusion of 5-fluorouracil (5-FU) (infusion duration greater than or equal to 5 days) or other fluoropyrimidines.
* Therapeutic doses of coumarin derivatives (warfarin) 14 days prior to receiving the first dose of study treatment or during the study period.
Please note: There are additional criteria that must be met in order to be eligible for this study.
|
NCT_ID
NCT00124527
|
Study_NameStudy of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer
| 1,670 |
Study Objectives
This phase I trial is studying the side effects and best dose of GTI-2040 in treating patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic syndromes, or refractory or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as GTI-2040, work in different ways to stop the growth of cancer or abnormal cells, either by killing the cells or by stopping them from dividing.
Conditions: Acute Undifferentiated Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: GTI-2040, PROCEDURE: pharmacological study, PROCEDURE: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Diagnosis of 1 of the following:
* Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) refractory to primary standard induction therapy
* Relapsed or refractory acute leukemia
* Chronic myelogenous leukemia (CML) in blast crisis at diagnosis OR that failed prior aggressive induction chemotherapy
* Diagnosis of 1 of the following:
* Acute leukemia secondary to preexisting hematologic condition or prior chemotherapy at diagnosis OR that failed prior aggressive induction chemotherapy
* Advanced myelodysplastic syndromes (intermediate-1 or greater)
* De novo acute leukemia (myeloid or nonmyeloid)
* Not a candidate for aggressive standard induction chemotherapy
* De novo AML or ALL (patients > 60 years)
* No suspected or proven active CNS leukemia
* ECOG performance status (PS) 0 <= age <= 2 OR Karnofsky PS 50 <= age <= 100%
* Life expectancy >= 8 weeks
* Bilirubin =< 1.5 mg/dL
* AST and ALT < 3 times upper limit of normal (ULN)
* Creatinine =< 1.5 times ULN
* No HIV positivity
* Fertile patients must use effective contraception
* No history of allergic reactions attributed to other phosphorothiolated oligonucleotides
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing, active, or poorly controlled infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Cardiac arrhythmia
* Poorly controlled pulmonary disease
* Psychiatric illness or social situation that would preclude study compliance
* Recovered from all prior therapies
* Prior autologous or allogeneic stem cell transplantation allowed (No active graft-vs-host disease > grade 2)
* At least 2 weeks since prior and no concurrent cytotoxic chemotherapy
* At least 2 weeks since prior and no concurrent biologic therapy
* At least 2 weeks since any other prior investigational agent
* No other concurrent anticancer therapy, including radiotherapy or hormonal therapy
* Concurrent imatinib mesylate for CML allowed
* Not pregnant or nursing
* Negative pregancy test
|
NCT_ID
NCT00459212
|
Study_NameGTI-2040 in Treating Patients With Relapsed, Refractory, or High-Risk Acute Leukemia, High-Grade Myelodysplastic Syndromes, or Refractory or Blastic Phase Chronic Myelogenous Leukemia
| 13,118 |
Study Objectives
The purpose of this study was to determine whether combined treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. The investigators anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with metformin.
Conditions: PCOS, Obesity
Intervention / Treatment:
DRUG: metformin, DRUG: metformin and roflumilast
Location: Slovenia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* 18 years to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher
Exclusion Criteria:
* depression
* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* significant cardiovascular, kidney or hepatic disease
* the use of medications other than metformin known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry
|
NCT_ID
NCT02037672
|
Study_NamePDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome
| 9,564 |
Study Objectives
Investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. Investigators hypothesize that spinal anesthesia as an adjunct to general anesthesia will reduce postoperative pain and opioid requirements.
Conditions: Rectal Cancer, Postoperative Pain
Intervention / Treatment:
DRUG: Bupivacaine Injection
Location: Norway
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria
*All patients undergoing laparoscopic abdominoperineal rectal amputation for rectal cancer * Age 18 <= age <= 100 years are eligible for enrollment in the study.
Exclusion Criteria
* ASA IV,
* BMI>35,
* contraindication to spinal analgesia
* allergy to any of the drugs used in this study protocol,
* chronic use of opioids or steroids,
* liver or renal impairment,
* patients scheduled for synchronous laparoscopic liver metastatic surgery
* inability to communicate in Norwegian.
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NCT_ID
NCT05406765
|
Study_NameEnhanced Recovery After Laparoscopic Colorectal Surgery
| 361 |
Study Objectives
The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival.
Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival.
Conditions: Diffuse Large B Cell Lymphoma
Intervention / Treatment:
DRUG: Revlimid
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:Understand and voluntarily sign an informed consent form.
* Age 18 years at the time of signing the informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements.
* Histologically confirmed diffuse large B cell lymphoma
* Relapsed or refractory after one prior therapeutic treatment for DLBCL. Refractory is defined as patients received adequate prior treatment and did not respond during treatment or progressed within 90 days of last treatment.
* Measurable disease with at least on bidimensional lymph node or tumor mass >1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
* Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease
* Eligible for autologous stem cell transplant
* All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study.
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 at study entry (see Appendix B).
* Laboratory test results within these ranges:
* Absolute neutrophil count >1000 /mm³
* Platelet count > 50,000/mm³ (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Calculated creatinine clearance of >= 60 mL/min by Cockroft-Gault formula (Appendix E) for patients enrolled into the phase I portion of the study (Stage I). Calculated creatinine clearance of >= 30 mL/min by Cockroft-Gault formula for patients enrolled into the phase II portion of the study (Stage II). See Section 5.4.2 for lenalidomide dose adjustment for calculated creatinine clearance > 30ml/min and < 60ml/min.
* Total bilirubin < 1.5 x Upper Limit of Normal (ULN).
* Aspartate Aminotransferase (SGOT) and Alanine Aminotransferase (SGPT) < 3 x ULN.
* Disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
* All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
* Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
* Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin).
-
Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Known hypersensitivity to thalidomide.
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Concurrent use of other nonprotocol anti-cancer agents or treatments.
* Known positive for HIV or active infectious hepatitis, type B or C.
* Refusal of autologous stem cell transplant.
* Patients with active central nervous system involvement based on clinical evaluation. Previously treated central nervous system (CNS) involvement that has remained asymptomatic for more than ninety days is allowed if no active CNS disease present as confirmed by MRI or/and lumbar puncture.
* Concurrent uncontrolled serious medical ort psychiatric conditions likely to interfere with participation in this clinical study, as judged by investigator.
* Prior Lenalidomide exposure for more than 28 days.
-
|
NCT_ID
NCT01241734
|
Study_NameStudy of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL
| 6,547 |
Study Objectives
The purpose is to determine if use of rectal spacers are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects. It is also to determine whether it provides sufficient dosimetric benefits to warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation) related clinical studies.
Conditions: Prostate Cancer
Intervention / Treatment:
DEVICE: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* All patients must be willing and capable to provide informed consent to participate in the protocol.
* Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 (a, b, or c) or T2a or T2b adenocarcinoma of the prostate gland. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation of cancer will be required by biopsy performed within 180 days of registration.
* The patient's Zubrod performance status must be 0 <= age <= 2.
* The Gleason score should be less than or equal to 6 or 3+4 if < 50% of a 12 core biopsy was involved.
* The serum PSA should be less than or equal to 10 ng/ml.
* Study entry PSA must not be obtained during the following time frames: 10 day period following prostate biopsy; following initiation of ADT; within 30 days after discontinuation of finasteride; or within 90 days after discontinuation of dutasteride.
* Age >= 18 years.
* Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment.
* The ultrasound, or CT based volume estimation of the patient's prostate gland should be <= 60 grams.
Exclusion Criteria:
* Subjects who have had previous pelvic radiotherapy or have had chemotherapy or surgery for prostate cancer.
* Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer.
* Subjects who have undergone previous transurethral resection of the prostate (TURP) or cryotherapy to the prostate. Subjects who have significant urinary obstructive symptoms; AUA score must be <=15 (alpha blockers allowed).
* Subjects who have a history of significant psychiatric illness.
* Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermacidal foam, intrauterine device (IUD), or prescription birth control pills.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
* Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
* Transmural myocardial infarction within the last 6 months.
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
* Patients with history of inflammatory colitis (including Crohn's Disease and Ulcerative colitis) are not eligible.
* Subjects with a known allergy to polyethylene glycol hydrogel (spacer material) or contraindication to spacer products (Duraseal or SpaceOAR).
* Subjects with evidence of extraprostatic extension (T3a) or seminal vesicle involvement (T3b) on clinical evaluation.
|
NCT_ID
NCT02353832
|
Study_NameStereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer
| 15,292 |
Study Objectives
The main objectives of this trial are:
1. To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in men with metastatic CRPC who have not received prior chemotherapy.
2. To evaluate archival prostate cancer tissue of men included in the clinical trial for evidence of autophagy using IHC for LC3B, ATG5, p62 as well as ERG.
3. To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Pantoprazole
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age >=18yrs
* ECOG performance status <=2
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Clinical or radiological evidence of metastatic disease
* Disease progression while receiving androgen deprivation therapy with an increase in PSA of 25% or greater over nadir value measured on 3 consecutive occasions at least 1 week apart
* Antiandrogen therapy must have been stopped at least 4 weeks prior to start of trial treatment (6 weeks in the case of bicalutamide or nilutamide)if there was a reduction in serum PSA after this therapy was initiated
* Baseline serum prostate-specific antigen (PSA)>=10ng/ml
* Total testosterone <50 ng/dL (<1.7 nmol/L)
* Adequate hematologic values: neutrophil count >=1,500/mm3, platelet >=100,000/mm3, hemoglobin >=10.0 g/dl
* Adequate hepatic and renal function: total bilirubin level <=1.5 x ULN (unless secondary to documented Gilbert's disease); ALT,AST, and creatinine <=1.5 x ULN
* Ability to understand and to sign consent for the study
Exclusion Criteria:
* Prior treatment for prostate cancer with chemotherapy or radioisotopes
* History of another cancer within the preceding five years (except basal or squamous-cell skin cancer or adequately treated superficial bladder cancer)
* Known or suspected brain or leptomeningeal metastases
* Symptomatic peripheral neuropathy of grade 2 or higher
* Major surgery within 4 weeks of start of trial treatment
* Radiotherapy to >=25% of the bone marrow and any radiotherapy within 4 weeks of start of trial treatment
* Known hypersensitivity to trial treatment or hypersensitivity to any of its components
* Any concomitant drugs contraindicated for use with the trial treatment
* Any serious underlying medical condition which could impair the ability of the patient to participate in the trial
* Any psychological, familial, sociological or other patient related factors that might preclude compliance with the study protocol
|
NCT_ID
NCT01748500
|
Study_NamePantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer
| 14,808 |
Study Objectives
Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
Conditions: Colorectal Cancer, Cytokine-induced Killer Cells, Postoperative Complications, Survival
Intervention / Treatment:
DRUG: Cytokine-induced killer cells+ FOLFOX4, DRUG: FOLFOX4
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Tumor, Nodes, Metastasis (TNM) stage of II or III;
* Patients received radical resection of colon cancer;
* Pathological diagnosis of adenocarcinoma;
* Patients not received radiotherapy and chemotherapy before surgery;
* The preoperative examination confirmed without systemic metastasis;
* Patient has the Karnofsky score more than 70 points;
* Subjects signed informed consent.
Exclusion Criteria:
* Patients who was serious allergy to any of the ingredients of drugs used in this study;
* Patients who unable to comply with the treatment plan or research program;
* Patients with severe systemic disease that the researchers judged will be unable to complete the study;
* Patients have severe heart disease, such as myocardial infarction within 6 months;
* Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
* Patients received radiotherapy;
* Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free;
* Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months).
* Patients who do not get effective treatment of inflammation, eye infections or predisposing factors;
* Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study;
* Patients with serious active infections;
* Woman who are pregnant or lactating.
|
NCT_ID
NCT03084809
|
Study_NameChemotherapy Combined With CIK Treating Colon Cancer
| 17,793 |
Study Objectives
This is a multicenter, open-label extension study. Subjects who have received rhuMAb VEGF therapy in Study AVF2107g, AVF2119g, or AVF2192g and who completed the parent study are eligible for inclusion in this trial. Subjects who have received placebo in Study AVF2107g or AVF2192g are also eligible.
Conditions: Breast Cancer, Colorectal Cancer, Metastases
Intervention / Treatment:
DRUG: Avastin (bevacizumab)
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Masking: NONE
|
Inclusion Criteria:
* Written informed consent
* Previous participation in and completion of one of the following Genentech-sponsored rhuMAb VEGF Phase II or Phase III cancer studies: AVF2107g, AVF2119g, or AVF2192g
* Use of an effective means of contraception in men and in women of childbearing potential
* For subjects who received placebo in the parent study, current antitumor therapy not exceeding third-line treatment for disease progression
Exclusion Criteria:
* Compromised renal or hepatic function, as defined in the parent protocol
* EGOG status of 3 or greater
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored rhuMAb VEGF cancer study
* ANC of <1500/uL
* Platelet count of <75,000/uL
* International normalized ration (INR) >=1.5 (except those subjects who have been given approval to receive full-dose warfarin plus rhuMAb VEGF)
* Total bilirubin of >1.6 mg/dL for patients receiving irinotecan, for all others total bilirubin of >2.0 mg/dL
* AST or ALT >5 times upper limit of normal for subjects with documented liver metastases; >2.5 times the upper limit of normal for subjects without evidence of liver metastases
* Serum creatinine of >2.0 mg/dL
* Hemoglobin of <9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level)
* Inability to comply with study and/or follow-up procedures
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
* Any unresolved or irreversible rhuMAb VEGF-related ongoing serious adverse event occurring during the parent study
* Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [blood pressure of >160/110 mmHg on medication], previous myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater)
* History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study
* Fine needle aspirations or core biopsies within 7 days prior to Day 0
* Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
* Pregnancy (positive pregnancy test) or lactation
* Proteinuria at baseline or clinically significant impairment of renal function
* Serious, nonhealing wound, ulcer, or bone fracture
* Evidence of bleeding diathesis or coagulopathy
|
NCT_ID
NCT00096967
|
Study_NameA Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer Study
| 9,403 |
Study Objectives
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.
Conditions: Chronic Myeloid Leukemia
Intervention / Treatment:
DRUG: Imatinib mesylate 400 mg
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* CML Ph+ (assessed by cytogenetic or FISH)
* Chronic phase with less than 5% bone marrow blasts
* Diagnosis within 12 months
* Age >= 70 year at inclusion
* PS grade 0 to 2 (ECOG)
* Mini mental status more than 25
* Hydroxyurea optional before Imatinib
* Adequate end organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.
Exclusion Criteria:
* patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
* Mini mental status <= 25
* patients who are not able to adequately take the study drug
* Age less than 70 y
* accelerated or blastic phase
* previous therapy with imatinib or interferon
* HIV positivity
|
NCT_ID
NCT00219752
|
Study_NameSafety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
| 15,633 |
Study Objectives
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
Conditions: Breast Neoplasms
Intervention / Treatment:
DRUG: bivatuzumab mertansine
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* female patients aged >= 18 years
* patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
* patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
* measurable tumour deposits by one or more radiological techniques (MRI, CT)
* life expectancy of at least 6 months
* Eastern Cooperative Oncology Group (ECOG) performance score <= 2
* patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)
Exclusion Criteria:
* hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
* known secondary malignancy requiring therapy
* active infectious disease
* brain metastases requiring therapy
* neuropathy common toxicity criteria (CTC) grade 2 or above
* absolute neutrophil count less than 1,500/mm3
* platelet count less than 100,000/mm3
* bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent)
* aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
* serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)
* concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
* chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
* radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
* women who are sexually active and unwilling to use a medically acceptable method of contraception
* pregnancy or lactation
* treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
* patients unable to comply with the protocol
|
NCT_ID
NCT02254005
|
Study_NameSingle Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer
| 20,488 |
Study Objectives
The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Zoledronic acid
Location: Greece
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria
* Prostate cancer
* Radical prostatectomy or external beam irradiation therapy within 6 months before study entry.
* No bone metastases according to bone scan
Exclusion Criteria
* Metastatic prostate cancer
* Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy
* Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year.
Other protocol-defined inclusion / exclusion criteria may apply.
|
NCT_ID
NCT00219271
|
Study_NameEffect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
| 18,363 |
Study Objectives
The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS in combination with Platinum-Gemcitabine based doublet first line therapy in stage IV non-small cell lung cancer (NSCLC) patients.
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: OCZ103-OS, DRUG: Platinum, DRUG: Gemcitabine
Location: Poland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Written Informed Consent;
* Males or females;
* 18 <= age <= 75 years;
* Histologically or cytologically confirmed stage IV NSCLC patients that are eligible to platinum-gemcitabine based doublet therapy (M1a and M1b, seventh edition descriptor of the Revised International System for Staging Lung Cancer, adopted by the AJCC.) Patients with a prior diagnosis of stage IIIa or IIIb NSCLC who have progressed to stage IV are also eligible;
* ECOG performance 0 or 1;
* One or more tumor lesions measurable by RECIST criteria version 1.1, on CT scan or MRI;
* Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the selected measurable lesions are outside the original radiation therapy port unless there has been demonstrated progression in the lesion. Radiation therapy must have been completed > 4 weeks prior to study entry;
* Palliative radiotherapy must have been completed > 2 weeks prior to study entry. Concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed;
* Life expectancy of at least 3 months
Exclusion Criteria:
* Any prior systemic therapy for recurrent or metastatic NSCLC, except prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC if administered at least 6 months prior to enrolment;
* Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2; atrial fibrillation of any grade; QTc interval > 450 msec for males or > 470 msec for females or uncontrolled intercurrent illness, e.g. unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia < 50 bpm; a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome);
* Systolic Blood Pressure < 100 mmHg (if deemed clinically significant by the treating physician);
* Uncontrolled diabetes. Patients with well controlled diabetes, with a HbA1C of less than 7%, on stable hypoglycaemic therapy and diet, are eligible;
* Clinically significant renal impairment or chronic pancreatitis;
* History of clinically significant hypoglycemia, with fasting blood glucose < 3 mmol/L;
* Inadequate baseline organ function as shown by following laboratory values:
* Hemoglobin < 100 g/L
* Absolute neutrophil count <1.5 x 10e9/L
* Platelet count < 100 x 10e9/L
* Total bilirubin > 1.5 x ULN
* AST and ALT > 2.5 x ULN or > 5 ULN in the presence of liver metastases
* Serum creatinine > 1.5 x ULN or calculated creatinine clearance < 60 ml/min
* To be dependent of oxygen treatment;
* Active infections requiring antibiotics;
* A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study;
* Pregnancy or breastfeeding. All women of child-bearing potential must have a negative pregnancy test prior to first receiving protocol therapy;
* Active alcohol or drug abuse;
* Known or suspected allergy/hypersensitivity to any agent given in the course of this trial;
* Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect;
* Other malignancies diagnosed within the last 5 years with the exception of Basal Cell Carcinoma of the skin;
* Patients unable to comply with the study protocol and follow-up schedule for any psychological, familial, sociological or geographical reason.
|
NCT_ID
NCT01844791
|
Study_NameAn Exploratory Study of OCZ103-OS in Combination With Standard of Care in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients
| 3,024 |
Study Objectives
Warts are common, benign, epidermal proliferations caused by HPV infecting skin and mucous membranes. Treatment of warts poses a true challenge despite existing variable therapeutic modalities, whether destructive or immunotherapeutic. Human papilloma virus (HPV) vaccines are FDA approved for the prevention of genital warts and wart related precancerous and cancerous lesions but they are not indicated for treatment of preexisting warts yet
Conditions: Verruca Viral
Intervention / Treatment:
DRUG: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine, DRUG: Bivalent Human Papilloma Virus Vaccine, DRUG: Saline
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Adult Patients with recalcitrant multiple warts of any type. Warts were considered recalcitrant if they persisted for at least 6 months without any response to 2 different therapeutic modalities or more.
* Immunocompetent patients.
* Patients who do not receive any treatment of warts for at least 1 month before the start of study.
* Patients who are able to understand and follow the study protocol and approve to sign the informed consent
Exclusion Criteria:
* Patients with acute febrile illness.
* Past history of asthma.
* Allergic skin disorders, such as generalized eczema, or severe urticaria.
* Pregnancy or lactation
* History of hypersensitivity to the treatment vaccines.
* Children
* Immunocompromised patients
* Patients unable to follow the study protocol
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NCT_ID
NCT05383625
|
Study_NameGardasil Versus Cervarix in the Treatment of Warts
| 14,703 |
Study Objectives
The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
DRUG: Panitumumab, DRUG: Irinotecan
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Pathologically confirmed unresectable metastatic colorectal cancer (mCRC) which has progressed on at least one prior 5-fluorouracil (5FU)-containing chemotherapy regimen
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of >= 3 months as documented by the investigator
* Baseline actual body weight <= 160 kg
* Competent to comprehend, sign, and date a written Institutional Review Board (IRB) approved informed consent form before any study-specific procedures are performed
Exclusion Criteria:
* Treatment with radiotherapy <= 14 days before enrollment. Patients must have recovered from all radiotherapy-related toxicities
* Known presence of central nervous systems (CNS) metastases
* Any prior malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent with no evidence of disease <= 2 years before enrollment
* History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > Common Terminology Criteria for Adverse Events (CTCAE version 3) grade 2
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <= 1 year before enrollment
* UGT1A1*28 TA7/7, TA7/8, TA8/8 genetic polymorphisms; Gilbert's Disease
* Treatment with CYP3A4 enzyme inhibiting or inducing medications <= 2 weeks before enrollment
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
* Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days before enrollment
* Subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine), however corticosteroids are allowed
* Major surgery < 28 days prior to enrollment or minor surgery (excluding catheter placement) < 14 days before enrollment
|
NCT_ID
NCT00563316
|
Study_NameEffect of Panitumumab on the Pharmacokinetics of Irinotecan
| 6,978 |
Study Objectives
The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.
Conditions: Tumors, Neoplasm Metastasis
Intervention / Treatment:
DRUG: Rapamycin (sirolimus), OTHER: Grapefruit Juice
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Patients with hematologic malignancies (lymphoma, multiple myeloma and chronic lymphocytic leukemia (CLL) only) are eligible to participate in the phase IB portion of the trial only.
* At least 4 weeks since prior chemotherapy or radiation therapy
* Aged >= 18 years
* ECOG performance status 0 <= age <= 2
* Life expectancy of greater than 3 months.
* Normal organ and marrow function:
* No transfusions of packed red blood cells within 1 week of starting treatment
* Leukocytes greater or equal to 3,000/μL
** White blood cell (WBC) greater or equal to 1,500/μL for patients with hematologic malignancies
* Absolute neutrophil count (ANC) greater or equal to 1,500/μL
** ANC greater or equal to 1,000/μL for patients with hematologic malignancies
* Platelets (PLT) greater or equal to 100,000/μL
** PLT greater or equal to 50,000/μL for patients with hematologic malignancies
* Total bilirubin within normal institutional limits
* AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times institutional upper limit of normal
* Serum triglycerides less than or equal to 500 mg/dl
* Creatinine within normal institutional limits OR creatinine clearance greater or equal to 60 mL/min for patients with creatinine levels above institutional normal
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* May not be receiving any other investigational agents.
* Uncontrolled brain metastases or malignancy. Cannot be receiving enzyme-inducing anticonvulsants.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin
* Gastrointestinal malabsorption syndromes, partial small bowel obstruction, or any illness that would interfere with the ability to absorb oral medications.
* Uncontrolled intercurrent illness
* Severe immunodeficient states (as judged by the treating physician)
* Pregnant women are excluded from this study; breastfeeding should be discontinued.
* HIV-positive patients receiving combination antiretroviral therapy are excluded.
* Concurrent use of ketoconazole, cyclosporine, tacrolimus, diltiazem, and rifampin with rapamycin is not permissible. The concurrent use of calcium channel blockers, terfenadine, astemizole, cisapride, propafenone, cyclosporine, midazolam, triazolam, quinidine, or theophylline with grapefruit juice is not permissible.
|
NCT_ID
NCT00375245
|
Study_NameRapamycin With Grapefruit Juice for Advanced Malignancies
| 20,678 |
Study Objectives
The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature.
Economic analyses are currently one of the criteria used in medical decision, beside effectiveness, quality of life and toxicities.
However, Economical comparison shows significant variations in the acquisition costs of the two drugs. Consequently, it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment.
As there is no difference in the effectiveness between the two treatments, a cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an economical point of view (payer).
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: Alimta®, DRUG: Taxotere®
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
* Metastatic relapses allowed if asymptomatic.
* Progressive disease during or after a standard first line platinum-based chemotherapy (without taxotere or alimta)
* Only one chemotherapeutic line including adjuvant and neo adjuvant treatment.
* Irradiation allowed if < 25% bone medulla . It may be ended 2 weeks before the second line treatment.
* At least one measurable target lesion according to recist criteria in non previously irradiated area.
* Performance status <=2
* Age between 18 and 70 years
* Life expectancy > 12 weeks.
* Normal hepatic function
* Normal renal function
* Normal serum calcium
* Absolute neutrophil count>1.5 gigal/l,platelets>100 gigal/l,haemoglobin>9.0 g/dl
* Written informed consent
Exclusion Criteria:
* SCLC, bronchioli-alveolar and neuro-endocrine carcinoma.
* Symptomatic brain metastases.
* Superior vena cava syndrome.
* Uncontrolled fluid retention in the third space (pleural or ascitic collection)
* Prior chemotherapy without platin
* Other concomitant diseases: heart failure, angina pectoris, tachyarrythmia, recent myocardial infarction, active infections.
* Peripheral neuropathy grade >= 2.
* Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
* Hypersensitivity to docetaxel or polysorbate 80.
* Unability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids.
* Pregnancy or breast feeding.
* Follow-up of the patient impossible.
* Prisoners
|
NCT_ID
NCT00284778
|
Study_NamePharmaco-economic Study of a Second Line Treatment in Advanced Non Small Cell Lung Cancer
| 19,248 |
Study Objectives
The purpose of this research study is to learn whether panitumumab helps treat colorectal cancer in participants who have not responded to treatment with cetuximab. Panitumumab is a human monoclonal antibody. Antibodies are proteins that recognize a foreign substance in the body and then attach themselves to it making it exposed to destruction. Panitumumab attaches itself to a protein on cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells to grow, and blocking EGFR helps prevent cancer cells from growing.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: panitumumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and measurable disease by RECIST criteria on CT or MRI
* Treated with cetuximab as part of their last treatment regimen for at least 4 weeks and must have been taken off cetuximab therapy for disease progression. Patients may or may not have been treated with 5-FU (5-Fluorouracil), oxaliplatin, irinotecan and bevacizumab. There is no maximal number of pre-existing treatment regimens. At least 2 weeks must have elapsed between previous anticancer therapy and the start of treatment on protocol, AND resolution of any skin rash related to prior treatment with epidermal growth factor receptor inhibitor
* ECOG (Eastern Cooperative Oncology Group) Performance Status 0, 1 or 2
* Life expectancy of greater than 3 months
* Normal organ, metabolic, and marrow function as defined in the protocol
* A wild-type tumor K-RAS gene (Kirsten rat sarcoma viral oncogene homolog) as determined by sanger sequencing of exon 2 from tumor DNA
* 18 years or older
Exclusion Criteria:
* History of untreated and or progression central nervous system metastases
* History of another primary cancer except: curatively treated in situ cervical cancer or breast; curatively resected non-melanoma skin cancer; other primary solid tumor curatively treated with no known active disease present and no treatment administered for 3 years or more prior to enrollment
* Intolerance to cetuximab leading to drug discontinuation due to rash, GI toxicity, or other grade 3 or 4 toxicities
* Radiotherapy < 14 days prior to enrollment
* Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies < 14 days before enrollment
* Subjects requiring chronic use of immunosuppressive agents
* Any investigational agent or therapy 30 days prior to enrollment
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with any study requirements
* History of interstitial lung disease
* Women who test positive for serum or urine pregnancy test or who are breast feeding
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NCT_ID
NCT00842257
|
Study_NamePanitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer
| 1,157 |
Study Objectives
The primary objectives of this trial were to determine the MTD of BIBF 1120 in combination with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: BIBF 1120, DRUG: Paclitaxel, DRUG: Carboplatin
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Male or female patients with histologically or cytologically confirmed Stage IIIB (including pleural effusion), IV or recurrent NSCLC
* Bi-dimensionally measurable disease by one or more techniques (CT, MRI, X-ray)
* Age >= 18 years
* Life expectancy of at least three (3) months
* Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
* Written informed consent that is consistent with ICH-GCP guidelines
Exclusion Criteria:
* Prior treatment for NSCLC including chemotherapy, biologic response modifier therapy, or any investigational drug
* Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
* Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy)
* Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels
* Cavitary or necrotic tumors
* Sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease
* Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
* Radiotherapy within 4 weeks preceding Day 0
* Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer)
* Gastrointestinal abnormalities that would interfere with intake or absorption of the study drug, such as a requirement for intravenous alimentation, prior surgical procedures affecting absorption, treatment for peptic ulcer disease within the last 6 months, active gastrointestinal bleeding unrelated to cancer (as evidenced by either hematemesis, hematochezia, or melena in the past 3 months and without endoscopic documented resolution), or malabsorption syndromes
* Significant cardiovascular disease (i.e., uncontrolled hypertension, myocardial infarction within 6 months, unstable angina, serious cardiac arrhythmia, >=NYHA Grade 2 congestive heart failure)
* History of hemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months
* Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months
* Concurrent therapeutic anticoagulation (except heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except chronic low-dose daily aspirin <325 mg)
* Known hypersensitivity to paclitaxel, carboplatin, or any of their excipients including Cremophor® (polyoxyethylated castor oil)
* Absolute neutrophil count (ANC) <=1,500/μl, platelet count <=100,000/μl, or hemoglobin <9 gm/dL
* Total bilirubin >1.5 mg/dL (26 μmol/L, SI Unit equivalent), alanine amino transferase (ALT) and/or aspartate amino transferase (AST) >=1.5 X ULN,
* Serum creatinine >1.5 mg/dL (>132 μmol/L, SI Unit equivalent)
* Persistent hematuria or proteinuria (more than trace)
* Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
* Pregnancy or breastfeeding
* Known or suspected active alcohol or drug abuse
* Patients unable to comply with the protocol
|
NCT_ID
NCT02182232
|
Study_NameA Dose Escalation Study of BIBF 1120 Together With Paclitaxel and Carboplatin in Patients With Advanced Stage Non-small-cell Lung Cancer
| 15,575 |
Study Objectives
This is a randomized, open label trial of HPV (human papilloma virus) vaccine, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either vaccine at 6 months or vaccine at 12 months.
Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that the GMTs in the test group (T) are non-inferior to the usual timing control group (C):
H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin.
Conditions: Human Papillomavirus Infection
Intervention / Treatment:
BIOLOGICAL: Quadrivalent human papillomavirus vaccine on-time administration, BIOLOGICAL: Quadrivalent human papillomavirus vaccine delayed administration
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* 18 <= age <= 23 year old college females who are planning to return to the university for the next fall semester.
Exclusion Criteria:
* Pregnancy or planned pregnancy.
* Prior receipt of HPV vaccine.
* Greater than four lifetime sexual partners.
* Immunosuppression.
* Anti-coagulant therapy.
* Breastfeeding.
* History of abnormal pap smear.
* Allergy to vaccine components.
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NCT_ID
NCT00572832
|
Study_NameRandomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
| 15,324 |
Study Objectives
The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Idarubicin, DRUG: Cytarabine, DRUG: Indoximod Freebase, DRUG: Indoximod HCL F1, DRUG: Indoximod HCL F2
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* A histologically or pathologically confirmed diagnosis of AML based on WHO classification with or without extramedullary disease except for central nervous system disease.
* ECOG performance status <= 2
* Left ventricular ejection fraction (LVEF) >= 50%
* Female patients of childbearing potential must have a negative pregnancy test < 1 week prior to enrollment.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients receiving any other investigational agents or immunotherapy
* Patients who have received prior chemotherapy for AML with the exception of hydroxyurea or leukapheresis for leukocytosis; prior hypomethylating or immunomodulatory agents for MDS are allowed
* Previous allo-HSCT of any kind
* Active, uncontrolled infection including known hepatitis B or C
* Active autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids.
* History of any other active cancer diagnosis
* Pregnant women
* Known HIV-infected patients
|
NCT_ID
NCT02835729
|
Study_NameA Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
| 5,364 |
Study Objectives
The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Abiraterone acetate, DRUG: Androgen deprivation, RADIATION: Radiation Therapy, DRUG: Prednisone
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* One of the following high risk criteria:
* Gleason Score 7 with PSA <= 20 ng/ml and clinical T1 <= age <= 2, or
* Gleason Score 8 <= age <= 10, PSA <= 20 ng/ml and clinical T1 <= age <= 2a, or
* PSA 10.1 <= age <= 40 ng/ml with GS < 7 and clinical T1 <= age <= 2, or
* Clinical T3 with Gleason Score < 7 and PSA <= 10 ng/ml.
* ECOG Performance Status <= 1
* Digital rectal exam within 90 days of registration on study
* CBC with differential with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) >= 1,500 cells/mm3, Platelets > 100,000/µL and Hemoglobin >= 9g/dL
* Serum potassium >= 3.5 mEq/L
* Serum albumin > 3.0 g/dl
* Total bilirubin < 1.5 X of institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) < 1.5 X ULN
* Calculated creatinine clearance > 60 mL/min
* Age > 18 years
* Able to swallow a whole tablet and take abiraterone acetate on an empty stomach (defined as no food for two hours before and one hour after abiraterone acetate ingestion)
* Ability to understand and sign a written informed consent document
* Written authorization for use and release of health and research study information has been obtained
* Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
* Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protections as determined acceptable by the principal investigator during the study and for 1 week after the last dose of abiraterone acetate.
Exclusion Criteria:
* Bone, visceral or soft tissue metastasis, including lymph nodes (>2 cm in longest diameter)
* Prior therapy for prostate cancer [Exceptions: LHRH agonist or antagonist may have been initiated within 30 days prior to enrollment. Bicalutamide may have been given within 60 days of enrollment as long as it has been stopped at least 7 days before enrollment and total duration was no longer than 30 days. This is to allow enrollment of those who have been given bicalutamide as a bridge for LHRH agonist/antagonist. It is highly unlikely a short non-overlapping course of bicalutamide will interact with abiraterone acetate in a measurable way. Previous alpha-reductase inhibitor use allowed IF patient has not been taking for at least 30 days prior to abiraterone acetate initiation, OR if alpha reductase inhibitor was not used as a primary treatment of prostate cancer and the PSA on alpha-reductase inhibitor remains within eligibility when doubled. ]
* Known serum testosterone <= 150 ng/dl or symptoms of hypogonadism (fatigue, hot flashes, hair loss, loss of muscle mass, osteoporosis, low libido, depression) prior to ADT initiation not explained by other medical co-morbidity OR history of testosterone supplement. If questionable, serum testosterone level greater than 150 ng/dl can be used to exclude hypogonadism.
* Previous malignancy within 3 years other than non-melanomatous skin cancer and non-muscle invasive bladder cancer
* Previous pelvic radiotherapy that would prevent prostate/SV irradiation
* Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
* History of gastrointestinal disorders that may interfere with the absorption of study drug (including gastric bypass surgery)
* Concurrent spironolactone use
* Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated or would interfere with the patient's ability to participate in the trial
* Receiving any investigational agents currently or within 30 days prior to study screening
* Prior demonstrated hypersensitivity, intolerance or allergy to abiraterone acetate, prednisone or their excipients
* Active co-morbidity, defined as follows:
* Chronic liver disease with cirrhosis (Child-Pugh B or C) or active hepatitis B or C
* History of pituitary or adrenal dysfunction
* Poorly controlled diabetes mellitus (A1c >9% or history of complications including peripheral neuropathy, end organ damage, hospitalization, amputation)
* Poorly controlled glaucoma
* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III-IV heart disease or known cardiac ejection fraction measurement of < 50% at baseline.
* Clinical evidence of active infection of any type, including active or symptomatic viral hepatitis.
* Known immune deficiency and/or HIV-positive patients
* Any medical condition that warrants long-term corticosteroid use in excess of study dose
* Patients taking strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital)
* Any condition that in the opinion of the Principal Investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing the study requirements
|
NCT_ID
NCT01717053
|
Study_NameAbiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer
| 22,056 |
Study Objectives
This pilot clinical trial studies the safety of a dendritic cell vaccine when given with gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the breast and local lymph nodes to other organs in the body. The vaccine is made up of natural cells found in the blood, called dendritic cells, and peptides, or small fragments of protein which are loaded onto the dendritic cells. This combination may help activate the immune system against stromal cells, which are cells that help cancer cells survive in the body. Gemcitabine hydrochloride is a chemotherapy drug that is given before the vaccine to help shrink the tumor and control cells that may interfere with the activity of the vaccine. Interfering with the stromal cells that help support the growth of cancer cells may lead to the death of the cancer cells.
Conditions: Breast Cancer, Metastatic Breast Cancer
Intervention / Treatment:
BIOLOGICAL: tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine, DRUG: gemcitabine hydrochloride
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must be human leukocyte antigen (HLA)-A2+
* Histologically confirmed breast cancer
* Patients must have evidence of metastatic disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease; Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable 10 mm soft tissue component that meets the measurability criteria per RECIST
* There is no limit to the number of prior systemic treatment regimens
* Patients must have a life expectancy of > 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1
* Prior GEM therapy is acceptable as long as the last dose was >= 3 months from registration on this study
* Patients may have treated and stable brain metastases; they must be off steroids and must have had stable brain metastases for at least 6 months
* White blood cell (WBC) > 3.0 x 10^9/L
* Platelets > 100 x 10^9/L
* Hemoglobin (Hgb) >= 10.0 gm/dl
* Creatinine < 1.5 mg/dl
* Bilirubin (total) < 2.0 ml/dl
* Aspartate aminotransferase (AST) < 5.0 x normal institutional limits
* Alkaline phosphatase < 2.5 upper limit of normal (ULN) (< 10 x ULN in presence of bone metastases)
* Serum calcium <= 12 mg/dl
* International normalized ratio (INR) < 1.5, except for subjects receiving warfarin therapy; for subjects who are receiving warfarin for prophylaxis or treatment of thrombosis, INR values should be carefully monitored while patients are on study
* All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient
* Patients must have a negative pregnancy test by urinalysis
* Use of an effective means of contraception (men and women) is mandated in subjects of child-bearing potential; female subjects will be advised that they not become pregnant for at least one month after completing participation in the study; avoiding sexual activity is the only certain method to prevent pregnancy; however, if subjects choose to be sexually active, they should use an appropriate "double barrier" method of birth control (such as female use of a diaphragm, intrauterine device [IUD], or contraceptive sponge, in addition to male use of a condom) or the use of prescribed "birth control" pills, injections, or implants
Exclusion Criteria:
* HLA-A2 negative patients
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
* Presence of bleeding diathesis
* Current treatment on another clinical trial
* Patients with organ allografts
* Pregnancy or breast-feeding; female patients must be surgically sterile or be post-menopausal, or must agree to use effective contraception during the period of therapy; all female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment; male patients must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
* Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
|
NCT_ID
NCT02479230
|
Study_NameType I-Polarized Autologous Dendritic Cell Vaccine With Tumor Blood Vessel Antigen-Derived Peptides in Metastatic Breast Cancer Patients
| 460 |
Study Objectives
Many ovarian cancer patients have been offered different standard cytostatics and gradually develop chemo-resistance. However, a considerable fraction of these patients are still in good general health and have a strong wish for further treatment.
Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has shown effect in patients refractory to docetaxel. Therefore, it could be anticipated that cabazitaxel may also have an effect in chemo-resistant ovarian cancer.
The aim of the study is to investigate whether cabazitaxel could be a reasonable treatment option in patients with chemo-resistant and refractory ovarian cancer with regard to effect and toxicity.
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: Cabazitaxel
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
* Platinum resistant ovarian cancer with at least two previous cytostatic regimens or platinum-refractory disease defined as progression while receiving the last line of platinum based therapy or within 4 weeks of last platinum dose
* Progression on previous treatment.
* Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria
* Age >= 18 years.
* Performance status 0 <= age <= 2.
* Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
* Neutrophils (ANC) >= 1.5 * 10^9/l
* Platelet count >= 100 * 10^9/l
* Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/l
* Serum bilirubin <= 1.0 * ULN
* Serum transaminase <= 2.5 * ULN
* Serum creatinine <= 1.5 ULN (at creatinine above 1.5 x ULN measured GFR must be at least 50 ml / min)
* Remaining life expectancy of at least 3 months
* Written informed consent
Exclusion Criteria:
* History of severe hypersensitivity reaction (>=grade 3) to taxol.
* History of severe hypersensitivity reaction (>=grade 3) to polysorbate 80 containing drugs.
* Allergy to the active substance or any of the auxiliary agents.
* Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2-week wash-out period is necessary for patients who are already on these treatments)
* Neuropathy grade >= 2.
* Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
* Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
* Other malignant diseases within 5 years prior to inclusion in the study, except basal cell or squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
* Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
* History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal, thyroid or liver disease).
* Vaccination with yellow fever vaccine or any live attenuated vaccine during the treatment.
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NCT_ID
NCT02560337
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Study_NameCabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.
| 15,777 |
Study Objectives
This is a multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy, safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in the patients with selected advanced solid tumors.
Conditions: Solid Tumor, Lung Cancer, HCC
Intervention / Treatment:
DRUG: AK105
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Written and signed informed consent.
* Aged over 18 and less than 75 years at the time of signing the informed consent form, both female and male.
* ECOG PS is 0 <= age <= 1.
* The expected survival time is >= 3months
* Histologically or cytologically confirmed selected advanced solid tumor.
* Subject must have at least one measurable lesion according to RECIST Version1.1.
* Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy.
* Adequate organ function.
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
* Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
* Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other requirements for the study.
Exclusion Criteria:
* Had received experimental drug or used experimental device in the past within 4 weeks prior to the first dose of study drug.
* Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization] within 4 weeks prior to the first dose of study drug.
* Had received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, etc.), or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways (such as ICOS, CD40, CD137, GITR, OX40 antibody or drug), immunocytotherapy, therapeutic antibody, etc.).
* Toxicity from previous anti-cancer therapy has not been alleviated or resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria.
* Patients with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
* Active or previously recorded inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea).
* Patients with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
* Large surgical procedures (defined by researchers as open biopsy, severe trauma, etc.) were performed within 28 days prior to the first dose of study drug.
* Known history of interstitial lung disease.
* Patients with untreated chronic hepatitis B or HBV DNA exceeding 1000IU/mL or active hepatitis C. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative.
* Patients with active tuberculosis (TB).
* History of known primary immunodeficiency virus infection or positive HIV testing.
* Severe infections within 4 weeks prior to the first dose of study drug, including but not limited to complications, sepsis or severe pulmonary infections requiring hospitalization.
* Patients with meningeal metastasis, spinal cord compression, pia mater disease or active brain metastasis. Patients who meet one of the following requirements may be enrolled: a). No central nervous system metastasis symptoms and signs, such as neurological dysfunction, epilepsy or other central nervous system metastasis before admission. No edema around the lesion found by imaging examination, and no brain metastasis more than 1.5 cm in length. b). Patients with central nervous system metastasis had received treatment and achieved asymptomatic status (e.g. without neurological dysfunction, epilepsy or other typical central nervous system metastasis symptoms and signs)
* Patients with pleural effusion, pericardial effusion or ascites that could not be controlled stably by repeated drainage or other methods as judged by the investigator.
* Receipt of live, attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live, attenuated vaccine during the study.
* Known history of sever hypersensitivity reaction to other monoclonal antibodies.
* Known history of allergy or hypersensitivity to AK105 or any of its components
* Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of results.
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NCT_ID
NCT04172506
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Study_NameA Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors
| 15,094 |
Study Objectives
This phase I trial is studying the side effects and best dose of ABT-888 when given in combination with temozolomide in treating young patients with recurrent or refractory CNS tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with temozolomide may kill more tumor cells.
Conditions: Childhood Atypical Teratoid/Rhabdoid Tumor, Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Ependymoblastoma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood High-grade Cerebellar Astrocytoma, Childhood High-grade Cerebral Astrocytoma, Childhood Infratentorial Ependymoma, Childhood Low-grade Cerebellar Astrocytoma, Childhood Low-grade Cerebral Astrocytoma, Childhood Medulloepithelioma, Childhood Mixed Glioma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Brain Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Spinal Cord Neoplasm, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma
Intervention / Treatment:
DRUG: veliparib, DRUG: temozolomide, OTHER: pharmacological study, OTHER: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients with a diagnosis of a primary CNS malignancy (including low-grade glioma) that is recurrent or refractory to standard therapy and for which there is no known curative therapy; all patients must have had histological verification of malignancy at initial diagnosis or relapse, excluding patients with diffuse intrinsic brain stem tumors, optic pathway tumors or CNS germ cell tumors with elevations of reliable serum or CSF tumor markers (alpha-fetoprotein or beta-HCG); patients with intrinsic pontine gliomas or optic pathway tumors do not require histological confirmation of disease but should have clinical and/or radiographic evidence of progression
* Patients must have Karnofsky Performance Score (for patients > 16 years) or Lansky Performance Score (for patients =< 16 years) >= 50% assessed within two weeks of study enrollment
* Patients must be able to take oral medications (either capsules or liquid); patients with neurologic deficits must have been stable for a minimum of 1 week prior to study entry; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study; recovery is defined as all AE"s, attributable to prior therapy, having improved to grade 2 or better or as outlined below
* Myelosuppressive chemotherapy:
* Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration
* Patients must have received their last dose of nitrosourea (including Gliadel) at least six (6) weeks prior to study registration
* Biologic agent (anti-neoplastic): Patient must have received their last dose of other biologic agent >= 7 days prior to study registration
* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
* Monoclonal antibody treatment: Patient must have received their last dose of monoclonal antibody >= 4 weeks prior to registration
* Radiation - Patients who have had prior radiation must have had their last fraction of:
* Craniospinal irradiation or total body irradiation > 3 months prior to registration
* Local irradiation to the primary tumors or other sites (cumulative dose >= 40Gy) > 3 months prior to registration
* Palliative irradiation delivered to symptomatic metastatic sites > 4 weeks prior to registration
* Stem Cell Transplant: Patient must be:
* >= 6 months since allogeneic stem cell transplant prior to registration
* >= 3 months since autologous stem cell transplant prior to registration
* Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration
* Growth factors:
* Off all colony forming growth factor(s) that support platelet or white blood cell count, number or function for at least 1 week prior to registration (filgrastim, sargramostim, erythropoietin)
* Off Pegylated G-CSF and/or Erythropoiesis Stimulating Protein for at least 14 days prior to registration
* Temozolomide: Patients who have received temozolomide previously are eligible for this study if they meet all other inclusion and exclusion criteria
* Organ Function: Documented within 14 days of registration and within 7 days of starting treatment
* Hgb > 8 gm/dL (transfusion independent)
* Platelet count > 100,000/mm^3 (transfusion independent)
* Absolute neutrophil count (ANC) > 1, 500/mm^3
* Total Bilirubin (sum of conjugated + unconjugated) <= 1.5 times institutional upper limit of normal (ULN) for age
* SGPT (ALT) <= 2.5 times institutional ULN for age
* Serum albumin >= 2 g/dL
* Creatinine clearance or radioisotope GFR >= 70 ml/min/1.73m^2 or a serum creatinine based on age as follows:
* <= 5 years - 0.8 mg/dL maximum serum creatinine
* > 5 to <= 10 years - 1 mg/dL maximum serum creatinine
* > 10 to <= 15 years - 1.2 mg/dL maximum serum creatinine
* > 15 years - 1.5 maximum serum creatinine
* Patients must not be pregnant or breast-feeding; females of reproductive potential must have a negative serum or urine pregnancy test (within 72 hours prior to enrollment); males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method, which includes abstinence
* Signed informed consent which includes consent to participate in the REQUIRED pharmacokinetic and pharmacodynamic studies prior to registration
Exclusion Criteria:
* Patients receiving any of the following medications are not eligible for study entry:
* Anti-cancer therapy
* Investigational agents
* Patients with any clinically significant, unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that would compromise the patient's ability to tolerate protocol therapy or would likely interfere with the study procedures or results
* Patients with uncontrolled seizures are not eligible for study entry
* Patients with inadequately controlled systemic hypertension (SBP and/or DBP > 95th percentile for age and height
* Patients with a prior history of hypertensive crisis and/or hypertensive encephalopathy
* If a BP measurement prior to registration is > 95th percentile for age and height, it must be rechecked and documented to be < 95th percentile for age and height prior to registration; if a patient falls between the height or weight percentiles, site should average the value as appropriate; for patients >= 18 years the normal blood pressure should be < 140/90 mm of Hg; patients with hypertension are eligible if their blood pressures become < 95th percentile for age and height after anti-hypertensive medications
* Patients with documented CNS ischemia and/or infarction, whether symptomatic or discovered incidentally without clinical symptoms, will be excluded from study participation
* Patients with an inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
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NCT_ID
NCT00946335
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Study_NameABT-888 and Temozolomide in Treating Young Patients With Recurrent or Refractory CNS Tumors
| 4,387 |
Study Objectives
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax.
1. Planned registration period 4 years
2. Planned surveillance period 5 years and 6 months
Conditions: Lymphoma, T-Cell, Peripheral
Intervention / Treatment:
DRUG: Istodax
Location: Japan
Study Design and Phases
Study Type: OBSERVATIONAL
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Inclusion Criteria:
* Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time.
Exclusion Criteria:
N/A
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NCT_ID
NCT03742921
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Study_NameISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma
| 12,699 |
Study Objectives
Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor D2 isoforms has been found in endocrine tumors.
Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.
Conditions: Chromaffin-tissue Derived Tumors
Intervention / Treatment:
OTHER: Scintigraphy in 123I-IBZM
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Age + 18 years. The women in ages to procreate have to have an effective contraception or a negative pregnancy test (in the absence of effective contraception) Having a radiological and functional imaging (balance sheet(assessment) pré--IBZM) considered adapted and complete for the pathology.
* Having a phéochromocytome or a paragangliome proving a surgical operation in view of the data of the balance sheet(assessment) pré--IBZM.
* With or without allergy in the iodine.
Exclusion Criteria:
* NEM2A or 2B.
* Malignant Forms which do not recover from an even partial, surgical gesture(movement).
* Pregnant Women or in the course of feeding.
* Women in age to procreate without effective contraception, with positive pregnancy test.
* Renal insufficiency
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NCT_ID
NCT00875407
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Study_NameFeasibility of 123I-IBZM Scintigraphy (a D2 Agonist) in Patients With Pheochromocytoma (PHEO) and/or Paraganglioma (PGL) : Study Pilot
| 17,592 |
Study Objectives
The main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects.
Conditions: Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer
Intervention / Treatment:
DRUG: Docetaxel, DRUG: PTK787
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Recurrent gynecological cancers or metastatic breast cancer. Initial diagnosis must be confirmed histologically.
* Measurable disease or nonmeasurable disease
* Age > 18 years
* ECOG performance 0,1,2
* 4 weeks or greater since major surgery, 3 weeks or greater since chemotherapy
* Certain lab values
* Negative for proteinuria
Exclusion Criteria:
* Four or more treatment regimens
* History or presence of uncontrolled CNS disease
* Prior biologic or immunotherapies less than 3 weeks prior to registration
* Prior full field radiotherapy less than 4 weeks or limited field radiotherapy less than 2 weeks prior to registration
* Prior therapy with anti-VEGF agents
* Peripheral neuropathy with functional impairment > CTC grade 2
* Pregnant or breast feeding
* Concurrent severe and/or uncontrolled medical condition
* Chronic renal disease
* Acute or chronic liver disease
* Impairment of gastrointestinal function or GI disease
* Confirmed diagnosis of HIV infection are excluded at the investigators discretion
* Therapeutic warfarin sodium or similar oral anticoagulants that are metabolized by the cytochrome p450 system.
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NCT_ID
NCT00268918
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Study_NameDocetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
| 7,779 |
Study Objectives
The purpose of this study is to assess the therapeutic activity of capecitabine alone or in combination with mitomycin C as second-line therapy in patients with advanced/metastatic biliary adenocarcinoma in progression after gemcitabine and platinum compounds
Conditions: Biliary Tract Cancer
Intervention / Treatment:
DRUG: capecitabine and mitomycin, DRUG: Capecitabine
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Signed and dated IRB/IEC-approved Informed Consent.
* Cytological or histological diagnosis of locally advanced or metastatic adenocarcinoma of the biliary tract (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary ducts).
* Disease progressing after first-line chemotherapy with gemcitabine and platinum analogs (only one prior systemic therapy allowed).
* Age 18 <= age <= 75 years
* Karnofsky Performance Status > 50%
* Estimated life expectancy of at least 3 months.
* Negative pregnancy test (if female in reproductive years).
* Adequate bone marrow, liver and kidney function: leukocyte > 3500/mm3; absolute neutrophil count (ANC) > 1500/mm3; platelet count > 100000/mm3; hemoglobin > 10 g/dl; creatinine < 1.5 mg/dL; total bilirubin <= 1.5 x upper limit of normal range (ULN); SGOT e SGPT <= 2.5 ULN
* At the time of start of treatment, at least 2 weeks must have elapsed since completion of prior chemotherapy, minor surgery and radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated).
* Resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTC (Version 4.03) grade <= 1 for hematologic toxicities and <= 2 for non hematologic toxicities, with the exception of alopecia.
* Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol.
Exclusion Criteria:
* Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasm without evidence of disease at least from 5 years.
* Known brain metastases.
* Previous second-line or adjuvant treatment.
* Concurrent treatment with other experimental drugs.
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, cardiac arrhythmia) <=1 year prior to dosing.
* Clinically significant disease including: Cerebral Vascular Accident; other serious underlying medical condition(s) which could impair the ability of the patient to participate in the study.
* History of interstitial lung disease (eg, pneumonia or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan
* Known positive tests for human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C
* Subject who is pregnant or breast feeding
* Woman or man of child-bearing potential not consenting to use adequate contraceptive precautions ie. double barrier contraceptive methods (e.g., diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug administration for women, and 1 month for men
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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NCT_ID
NCT01530503
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Study_NameSecond Line Therapy in Advanced Biliary Tract Cancer
| 17,129 |
Study Objectives
At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.
Conditions: Actinic Keratoses
Intervention / Treatment:
DRUG: imiquimod, DRUG: Aldara™, DRUG: Vehicle Cream
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
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Inclusion Criteria:
* Subjects were male or non-pregnant females, 18 years or older, in generally good health. Females who were post-menopausal, surgically sterile or using a medically acceptable form of birth control with a negative urine pregnancy test at the Baseline visit.
* Subjects provided written and verbal informed consent.
* Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment Area on the face and/or anterior scalp.
* Subjects were willing and able to comply with study instructions and return to the clinic for required visits.
Exclusion Criteria:
* Subjects who were lactating, or planning to become pregnant during the study.
* Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2 Treatment Area.
* Subjects who had the need or were planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
* Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
* Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
* Subjects with known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study drugs.
* Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod, diclofenac sodium or other treatments for AK or photodamage.
* Subjects who used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:
Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.
Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.
Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.
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NCT_ID
NCT00948428
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Study_NameBioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
| 18,666 |
Study Objectives
This phase II trial studies how well combination chemotherapy with or without bortezomib works in treating patients with classical Hodgkin lymphoma that has come back or does not respond to prior treatment. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib is designed to block a protein that plays a role in cell function and growth. Bortezomib may cause cancer cells to die. It is not yet known if combination chemotherapy with or without bortezomib may work better in treating patients with classical Hodgkin lymphoma.
Conditions: Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
Intervention / Treatment:
DRUG: Bortezomib, DRUG: Carboplatin, DRUG: Etoposide, DRUG: Ifosfamide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Relapsed or refractory classical Hodgkin lymphoma.
* Patients must have received a front-line standard anthracycline-containing regimen, such as adriamycin-bleomycin-vinblastine-dacarbazine (ABVD), Stanford V, or bleomycin-etoposide-adriamycin-cyclophosphamide-oncovin-procarbazine-prednisone (BEACOPP).
* Bi-dimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension.
* Absolute neutrophil count (ANC) >= 1,500/microL.
* Platelet count >= 100,000/ microL.
* Hemoglobin >= 8 g/dL.
* Serum bilirubin < 2.0 mg/dL.
* Alkaline phosphatase < 2 x upper limits of normal (ULN).
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 x ULN.
* Serum creatinine =< 1.5 mg/dL.
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
* Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test and must agree to use 2 highly effective contraceptive methods (hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after completion of protocol treatment. Females of non-childbearing potential are those who are postmenopausal for greater than 1 year or whom have had a bilateral tubal ligation or hysterectomy.
* Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 3 months after completion of protocol treatment.
* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion Criteria:
* Lymphocyte predominant Hodgkin lymphoma histology.
* More than one prior chemotherapy regimen.
* Prior autologous or allogeneic stem cell transplant.
* Presence of central nervous system (CNS) involvement with Hodgkin lymphoma.
* Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
* Active hepatitis B or C infection or history of cirrhosis.
* Grade 2 or greater peripheral neuropathy within 14 days of enrollment.
* Hypersensitivity to boron or mannitol.
* Prior bortezomib therapy.
* Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or squamous intraepithelial lesion on PAP smear, or treated prostate cancer with a stable prostate specific antigen [PSA]) for which the patient has not been disease-free for at least 3 years.
* Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
* Patients with a myocardial infarction 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiogram (ECG) evidence of acute ischemia or active conduction system abnormalities.
* Patient with other medical or psychiatric illness that is likely to interfere with participation in this clinical study.
* Female subject that is pregnant or breast-feeding.
* Patient that has received other investigational drugs within 14 days of enrollment.
* Patients using concurrent therapy with corticosteroids at greater than or equal to 20 mg/day of prednisone equivalent.
* Patients with active systemic bacterial, viral, or fungal infections that have required IV antimicrobials within 4 weeks prior to protocol treatment.
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NCT_ID
NCT00967369
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Study_NameCombination Chemotherapy With or Without Bortezomib in Treating Patients With Classical Hodgkin Lymphoma That Has Returned or Does Not Respond to Prior Treatment.
| 11,075 |
Study Objectives
This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.
Conditions: Depressive Symptoms, Anxiety, Cancer
Intervention / Treatment:
DRUG: psilocybin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: QUADRUPLE
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Inclusion criteria
Volunteers must:
* Have given written informed consent
* Have a high school level of education
* Be 21 <= age <= 80 old
* Has or has had a cancer diagnosis that is potentially life-threatening. Patients with an active cancer (e.g. stage III or IV with a poor prognosis) or disease progression or recurrence are eligible. Patients who do not have an active cancer or disease progression or disease recurrence are only eligible if at least 1 year has elapsed since their diagnosis.
* Have an ECOG performance status of 0, 1, or 2.
* Have a DSM-IV psychiatric diagnosis, as determined by the SCID, of one or more of the following Axis I psychiatric disorders that is either precipitated by or exacerbated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Post traumatic Stress Disorder; Major Depressive Disorder (mild or moderate severity); Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnosis will be determined by BPRU staff.
* Patients receiving chemotherapy, hormonal therapy, radiation therapy, biologic therapies may participate while receiving those therapies. Continuing hormonal therapy, chemotherapy, or radiation treatment is acceptable if the patient is tolerating the therapy or treatment in a sufficient fashion to allow administration of oral psilocybin.
* Agree that for one week preceding each psilocybin session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
* Agree not to use nicotine for at least 2 hours before psilocybin administration, and not again until questionnaires have been completed approximately 7 hours after psilocybin administration.
* Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of psilocybin session days. If the patient does not routinely consume caffeinated beverages, he or she must agree not to do so on psilocybin session days.
* Agree not to take any PRN medications on the mornings of psilocybin sessions, with the exception of daily opioid pain medication. Non-routine PRN medications for treating breakthrough pain that were taken in the 24 hours before the psilocybin session may result in rescheduling the treatment session, with the decision at the discretion of the investigators.
* Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each psilocybin administration. As described elsewhere, exceptions include daily use of caffeine, nicotine, and opioid pain medication.
Exclusion criteria
General Medical Exclusion Criteria
* Cancer with known CNS involvement, or other major CNS disease. In addition to diagnostic results provided by the referring physician, patients will undergo a neurological exam performed by our BPRU internist. Any patient with evidence of a focal deficit will be excluded.
* Hepatic dysfunction as indicated by the following values:
* GGT > 3 x ULN (upper limit of norm)
* AST > 3 x ULN
* ALT > 3 x ULN
* Tot Bili > 3.0 mg/dl
* Known paraneoplastic syndrome or "ectopic" hormone production by the primary tumor such as the patient could have or be at risk for hypercalcemia, Cushing's syndrome, hypoglycemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome
* Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrillation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication)
* Blood pressure exceeding screening criteria described below
* Epilepsy with history of seizures
* Renal disease (creatinine clearance < 40 ml/min using the Cockcroft and Gault equation)
* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
* Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
* Currently taking on a regular (e.g., daily) basis: investigational agents, psychoactive prescription medications (e.g., benzodiazepines), medications having a primary pharmacological effect on serotonin neurons (e.g., ondansetron), or medications that are MAO inhibitors. Long-acting opioid pain medications (e.g. oxycodone sustained release, morphine sustained release -- which are usually taken at 12 hour intervals) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration.
* For individuals who have intermittent or PRN use of investigational agents, psychoactive prescription medications, medications having a primary pharmacological effect on serotonin neurons, or medications that are MAO inhibitors, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
* In addition to the foregoing, patients will be excluded if they are currently using any the following of potent metabolic inducers or inhibitors: Inducers - Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, Phenobarbital), Nevirapine, Efavirenz, Taxol, Dexamethasone), St Johns Wort; Inhibitors - all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.
* In addition to the foregoing, patients will be excluded if it is a medical requirement that they receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl.
Psychiatric Exclusion Criteria
* Individuals with severity of depression or anxiety symptoms warranting immediate treatment with antidepressant or daily anxiolytic medication (e.g., due to suicidal ideation). We will interview patients to determine if referral (e.g., to Community Psychiatry) is necessary. For all individuals who are consented and screened, we will notify the referring physician as to: 1) whether the individual enrolled in the study or not, and 2) if disqualified, why the individual was disqualified. If disqualification was based on severe depression or anxiety (e.g., suicidal ideation), this will be included in the information conveyed to the referring physician. Permission for this contact will be obtained from the participant.
* Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder
* Current or past history within the last 5 year of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine).
* Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder.
* Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
Cardiovascular screening:
There will be at least four blood pressure assessment occasions over at least two separate days. Within a day, assessment occasions will be separated by at least 15 minutes. Each assessment occasion will involve two or more blood pressure readings. To qualify for the study, the mean blood pressure (mm Hg) of the four or more assessment occasions will not exceed 140 systolic and 90 diastolic.
Blood pressure will be taken while subjects are at rest and have been seated or supine for at least 5 minutes. As recommended by the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, these assessments will involve the average of 2 or more readings separated by two minutes. If the first 2 readings differ by more than 5 mm Hg, additional readings will be obtained and averaged. On one or more of the blood pressure measurement occasions, the volunteer will be acclimated to the automated blood pressure monitoring equipment by repeatedly taking blood pressure (at least 3 readings) with the device. Because it has been our experience that time-to-time blood pressure readings with the automated equipment can be variable due to measurement artifact, any reading that initially exceeds our threshold value will be reassessed twice within 4 minutes to assure accuracy.
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NCT_ID
NCT00465595
|
Study_NamePsychopharmacology of Psilocybin in Cancer Patients
| 13,898 |
Study Objectives
Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other solid tumors with bone metastases.
Conditions: Treatment of Bone Metastases
Intervention / Treatment:
DRUG: Zoledronic acid
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria
* Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of bone lesions
* Significant bone pain
Exclusion Criteria
* Poor renal function
* Use of other investigational drugs within 30 days of visit 2
* Dental or other surgery to the jaw within 6 weeks of screening, or planned during the 4 week study
Other protocol-defined exclusion criteria may apply.
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NCT_ID
NCT00219258
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Study_NameEfficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
| 4,501 |
Study Objectives
To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected markers of tumour burden and immunological status, and disease outcome.
Conditions: Advanced Pancreatic Cancer
Intervention / Treatment:
BIOLOGICAL: IMM-101, DRUG: Gemcitabine
Location: Cyprus, Spain, United Kingdom, Italy, Ireland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Male or female; aged >=18 years.
* Histologically and/or cytologically confirmed inoperable ductal adenocarcinoma of the pancreas, including the mucinous variant. This will include locally advanced and metastatic disease (stage III/IV).
* Presence of measurable lesions in at least one site which have not been previously irradiated (bone lesions, ascites and pleural effusions are not considered as measurable), described as any of the following:
* Any primary tumour with at least bi-dimensionally measurable disease.
* a) Palpable lymph nodes; b) Deep seated lymph nodes.
* Liver metastases measurable by computerised tomography (CT) scan.
* Deep seated soft tissue lesions measurable by CT scan.
* World Health Organization (WHO) performance status of 0 <= age <= 2
* Serum creatinine <140 μmol/L
* White blood cell (WBC) count, including differential counts within the normal range or, if outside the normal range, considered by the Investigator not to be clinically significant.
* Life expectancy of >3 months from randomisation.
* Provided written informed consent to participate as shown by a signature and date on the patient's Informed Consent Form
Exclusion Criteria:
* Acinar cell carcinoma, neuroendocrine tumours, lymphomas or squamous cell carcinomas.
* Severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments.
* Any previous chemotherapy treatment for pancreatic cancer.
* Eligible for resection of the pancreatic primary tumour but has either refused the operation or is considered to be medically unfit for the operation.
* Clinical or CT evidence of central nervous system (CNS) metastases.
* Any previous or concurrent malignancy, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non-melanoma skin cancer, or if previous malignancy was more than 5 years earlier and there were no signs of recurrence.
* Any previous treatment with IMM-101 or related mycobacterial immunotherapy.
* Serum albumin < 26 g/L.
* C-reactive protein (CRP) > 70 mg/L.
* Radiotherapy in the 6 weeks prior to screening.
* Depot corticosteroids in the 6 weeks prior to screening.
* Chronic use of any systemic corticosteroids and/or immunosuppressant drugs within the 2-week period prior to the first administration of study drug.
* Female patient of child-bearing potential who is not, in the opinion of the Investigator, using an approved method of birth control.
* Female patient who were pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment serum pregnancy test measuring human chorionic gonadotrophin (hCG) had to be negative.
* Had been administered any investigational product e.g. drug, vaccine or device, in the 3 months prior to screening.
* Surgical or medical condition which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
* Any uncontrolled concomitant disease (e.g. unstable angina pectoris, congestive heart failure, myocardial infarction, arrhythmias, and uncontrolled severe hypertension) which, in the judgement of the Investigator, might interfere with the activity of IMM 101, or with the performance of this study.
* A history of serious adverse reaction or serious hypersensitivity to any drug.
* Known to have a history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C. Testing is not required in the absence of clinical signs and symptoms suggestive of infection with HIV.
* Unable or unwilling to comply with the protocol.
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NCT_ID
NCT01303172
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Study_NameA Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
| 9,048 |
Study Objectives
To determine the primary end point response rate of the combinations of Gemcitabine and Oxaliplatin (Gem-Ox) in the treatment of hepatocellular carcinoma (HCC) in patients with platelet counts greater 100,000 per microliter in a single arme Phase II trial.
To determine the toxicity profile of this regimen To determine the effect of this treatment on patient survival, time to treatment failure, time ot progression, time to response.
Conditions: Liver Cancer
Intervention / Treatment:
DRUG: Gemcitabine and Oxaliplatin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* All patients 18 years or older, with hepatocellular carcinoma are eligible.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must have a ECOG performance status of 0 <= age <= 2.
* Patients must sign an informed consent.
* Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
* Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
* There must be one measurable lesion according to the RECIST criteria that should not have had prior radiation treatment.
Exclusion Criteria:
* Patients with symptomatic brain metastases that had not been adequately and definitively treated with radiation and/or surgical resection are excluded from this study.
* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
* Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
* Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
* Life expectancy of less than 12 weeks.
* Serious, uncontrolled concurrent infection(s)
* Any prior treatment with, Gemcitabine or Oxaliplatin .
* Completion of previous chemotherapy regimen less than 4 weeks, prior to start of this study or persistence of prior treatment related toxicity.
* Treatment for other carcinomas within the last five years, except for cured non-melanoma of the skin and treated in-situ cervical cancer.
* Participation in any investigational study within 4 weeks preceding the start of the study treatment.
* Clinically significant heart disease defined as NYHA class 3 or 4 heart disease.
* Chronic debilitating diseases that the investigator feels might compromise the study Participation.
* Evidence of inadequately treated CNS metastases.
* Major surgery within 4 weeks of the s1art of the study treatment without complete recovery.
* Known or existing uncontrolled coagulopathy.
* Any of the following laboratory parameters v) Abnormal hematological values with ANC less than 1500/mm3, thrombocytopenia less than 99,000. vi) Impaired renal function with a serum creatinine of greater than 1.5 ULN vii) Serum bilirubin greater than 1.5xULN viii) Albumin less than 2.5mg/dl.
* Unwillingness to give informed consent.
* Unwillingness to participate or inability to comply with the protocol for the duration of the study.
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NCT_ID
NCT00250822
|
Study_NameGemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,000 Per Microliter
| 6,812 |
Study Objectives
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.
Conditions: Ovarian Cancer, Epithelial Ovarian Cancer
Intervention / Treatment:
DRUG: Catumaxomab
Location: Germany, Austria
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* signed and dated informed consent form before any protocol-specific screening procedures
* patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) - IV)
* Karnofsky index > or equal 70
* female at an age of >= 18 years
* negative pregnancy test
Exclusion Criteria:
* exposure to prior cancer therapy specific for ovarian cancer
* previos treatment with non-humanized mouse or rat monoclonal antibodies
* known / suspected hypersensitivity to catumaxomab or similar antibodies
* second malignangcy within the last 5 years
* presence of constant immunosuppressive therapy
* presence of symptomatic heart failure or occlusive arterial diseases
* inadequate renal or hepatic function
* presence of any acute or chronic systemic infection
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NCT_ID
NCT00563836
|
Study_NamePhase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
| 8,398 |
Study Objectives
This study is designed as a Phase III, multicenter trial, comparing progression-free survival (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus BEAM transplant regimen versus a regimen adding Bexxar to BEAM.
Conditions: Lymphoma, B-Cell, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Non-Hodgkin
Intervention / Treatment:
DRUG: Autologous transplantation using rituxan/BEAM, DRUG: Autologous transplantation using Bexxar/BEAM
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Diagnosis of persistent or recurrent REAL classification diffuse large B-cell lymphoma, composite lymphoma with more than 50% diffuse large B-cell lymphoma, mediastinal B-cell lymphoma
* Demonstration of CD20+ on at least one histologic specimen
* 18 <= age <= 80 years at time of first registration
* Three or fewer prior regimens of chemotherapy over the entire course of their disease treatment (including one induction chemotherapy and no more than 2 salvage chemotherapies); monoclonal antibody therapy and involved field radiation therapy will not be counted as prior therapies
* Disease status of primary induction failure, first relapse, or second complete remission; all patients must have chemosensitive disease as demonstrated by response to induction or salvage chemotherapy with at least a partial response (as defined in the protocol)
* No more than a 20% bone marrow involvement
* Patients with adequate organ function as measured by:
* Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; additionally, patients greater than 60 years must have a left ventricular ejection fraction at rest of at least 40% demonstrated by Multi-Gated Acquisition Scan (MUGA)
* Hepatic: Bilirubin less than 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome) and alanine transaminase (ALT) and aspartate transaminase (AST) less than 3x the upper limit of normal
* Renal: Creatinine less than 2.0 mg/dL or creatinine clearance (calculated creatinine clearance is permitted) more than 40 mL/min; no hydronephrosis on CT scan prior to mobilization
* Pulmonary: Carbon Monoxide Diffusing Capacity (DLCO), Volume forcibly exhaled in one second (FEV1), forced vital capacity (FVC) at least 45% of predicted (corrected for hemoglobin)
* Autologous graft with a minimum of at least 1.5 X 10^6 CD34+ cells/kg (target greater than 2.0 X 10^6 CD34+ cells/kg. Peripheral blood stem cells (PBSC) are preferred; however, if PBSC mobilization fails, cells can be obtained by institutional practices (in cases where bone marrow will be used for transplantation, the required CD34+ dose does not apply and institutional practice for total nucleated cell dose should be used).
* Initiate conditioning therapy within 3 months of mobilization
* Signed informed consent
Exclusion Criteria:
* Karnofsky performance score less than 70%
* Transformed follicular lymphoma
* Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
* Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; cancer treated with curative intent less than 5 years previously will be allowed
* Pregnant (positive β-HCG) or breastfeeding; this patient population is excluded due to the lack of data on the use of Bexxar in patients who are pregnant or breastfeeding
* Seropositivity for HIV; this patient population is excluded due to the lack of data on the use of Bexxar in HIV positive patients and because the treatment regimens are too immunosuppressive for this patient population
* Fertile men or women unwilling to use contraceptive techniques from the time of initiation of mobilization until six-months post-transplant
* Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
* Patients with evidence of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) or abnormal cytogenetic analysis indicative of MDS on the pre-transplant bone marrow examination
* Patients with a prior severe reaction to Rituxan or Filgrastim (G-CSF). Patients with severe reactions to G-CSF that receive pre-medication for control of the reaction are not excluded from study.
* Patients who have received prior radioimmunotherapy
* Patients with known hypersensitivity to murine proteins
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NCT_ID
NCT00329030
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Study_NameRituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401)
| 487 |
Study Objectives
This study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. Approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.
Conditions: Non Small Cell Lung Cancer, Small Cell Lung Cancer
Intervention / Treatment:
DRUG: enzastaurin, DRUG: placebo
Location: Poland, Sweden, Denmark, Norway, Romania
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
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Inclusion Criteria:
* Having radiologically proven brain metastases of lung cancer
* Having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. Treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy
* No other previous radiotherapy to the brain except for radiosurgery at one occasion
* Adequate organ function as measured by appropriate laboratory tests.
* Age >= 18 years.
Exclusion Criteria:
* Inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction).
* Inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin.
* Concurrent administration of warfarin
* Hemophilia
* Having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.
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NCT_ID
NCT00415363
|
Study_NameStudy of Enzastaurin Versus Placebo in the Treatment of Patients With Brain Metastases of Lung Cancer, After Whole Brain Radiation Therapy
| 7,090 |
Study Objectives
This is a Phase Ib/II study to identify the recommended dose of paclitaxel and nivolumab for further study, and to assess the safety and clinical efficacy of this combined treatment in EBV-related, MSI-high, or PD-L1 positive advanced gastric cancer after first line treatment.
Conditions: Recurrent/Metastatic Gastric Cancer
Intervention / Treatment:
DRUG: Nivolumab, Paclitaxel
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Has provided digned written informed Consent
* Is male or female >=19 years
* Has a histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
* Has documented EBV-related, MSI-high, or PD-L1 positive tumor in primary or metastatic tumor tissue
* Has a life expectancy of at least 3 months
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has measurable or evaluable disease as determined by RECIST 1.1.
* Is able to swallow and retain orally administered medication
* Has an adequate baseline organ function defined as:
* White blood cells >=3000/mm3 and neutrophils >=1500/mm3
* Platelets >=100000/mm3
* Hemoglobin >=9.0 g/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3.0 × upper limit of normal (ULN) of the study site (or <=5.0 × ULN in patients with liver metastases)
* Total bilirubin <=2.0 × ULN
* Creatinine<=1.5 × ULN or creatinine clearance (either measured value or estimated value using the Cockcroft-Gault equation) >60ml/min.
Exclusion Criteria:
* Has HER2-positive or indeterminate gastric cancer
* Have multiple cancers
* Have a current or past history of severe hypersensitivity to any other antibody products
* Have concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
* Have a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging (preferably CT) or clinical findings
* Have brain or meninx metastases. Patients may be randomized for the study if they are asymptomatic and require no treatment.
* Have pericardial fluid, pleural effusion, or ascites requiring treatment
* Have a history of uncontrollable or significant cardiovascular disease
* Have systemic infection requiring treatment
* Are contraindicated for paclitaxel
* Has had prior treatment with:
- Require or, within 28 days before treatment, have received systemic corticosteroids or immunosuppressants
* Have undergone surgery (any surgery involving general anesthesia) within 28 days before study treatment
* Have received radiotherapy for gastric cancer within 28 days before treatment or radiotherapy for bone metastases within 14 days before treatment
* Have a positive test result for human immunodeficiency virus-1 (HIV-1) antibody,
* Hepatitis B surface protein (HBs) antigen and HBV titer >2000 IU/ml (10,000 copy/ml), or hepatitis C virus (HCV) antibody positive result
* Are pregnant or breastfeeding, or possibly pregnant
* Has any unresolved >=Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or anemia
* Have previously received nivolumab, anti-programmed cell death-1 (PD-1) antibody, anti-PD-L1 antibody, anti-programmed cell death-ligand 2 (PD-L2) antibody, anti-CD137 antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells
* Are incapable of providing consent for specific reasons, such as concurrent dementia
* Are otherwise inappropriate for this study in the investigator's or subinvestigator's opinion.
|
NCT_ID
NCT05535569
|
Study_NamePhase Ib/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With Paclitaxel in Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric Cancer
| 11,086 |
Study Objectives
This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
Conditions: Solid Tumors
Intervention / Treatment:
DRUG: gimatecan
Location: Germany, Spain, Netherlands, Canada, Denmark, Norway, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion criteria:
* Advanced or metastatic cancer
* 18 years and above
Exclusion criteria:
* Previous treatment with 4 or more cycles of carboplatin;
* Previous treatment with 2 or more courses of nitrosourea or mitomycin;
* Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
* Severe and/or uncontrolled medical conditions
Other protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT00420485
|
Study_NameDose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
| 15,260 |
Study Objectives
This trial will examine the combination of sunitinib plus paclitaxel and carboplatin as neoadjuvant treatment for locally advanced breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Paclitaxel, DRUG: Carboplatin, DRUG: Sunitinib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Female patients, age >=18 years
* Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast
* Triple-negative tumors are defined as:
* For HER2-negative:
* Fluorescence in situ hybridization (FISH)-negative (defined by ratio <2.2) OR
* Immunohistochemical (IHC) 0, IHC 1+, OR
* IHC 2+ or IHC 3+ and FISH-negative (defined by ratio <2.2)
* For ER- and PR-negative: <10% tumor staining by immunohistochemistry (IHC)
* Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter by physical exam or imaging studies (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1 <= age <= 3, N1 <= age <= 2, M0). T1N0M0 lesions are excluded. Patients with metastatic disease are excluded.
* Patients without clearly defined palpable breast mass or axillary lymph nodes but radiographically measurable tumor masses are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. Patients with lesions measurable only by imaging will require repeat imaging after 3 cycles and prior to surgery
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 <= age <= 2
* Neuropathy grade <1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0)
* Resolution of all acute effects of surgical procedures to grade <=1.
For patients who had, or will have sentinel lymph node and/or axillary dissection prior to initiation of study treatment, completion at least 4 weeks prior to starting study treatment and well-healed wound is required
* Adequate hematologic function with:
* Absolute neutrophil count (ANC) >1500/μL
* Platelets >=100,000/μL
* Hemoglobin >=10 g/dL
* Adequate hepatic and renal function with:
* Serum bilirubin <= the institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 x institutional ULN
* Alkaline phosphatase <=2.5 x institutional ULN
* Serum creatinine <=1.5 x ULN or calculated creatinine clearance >=40 mL/min
* Left ventricular ejection fraction (LVEF) >=50% by multigated acquisition (MUGA) or echocardiogram (ECHO)
* Bilateral, synchronous breast cancer is allowed if one primary tumor meets the inclusion criteria
* Knowledge of the investigational nature of the study and ability to provide consent for study participation
* Ability and willingness to comply with study visits, treatment, testing, and other study procedures
Exclusion Criteria:
* Previous treatment for this breast cancer
* Previous treatment with paclitaxel or carboplatin
* Previous treatment with sunitinib or other angiogenic inhibitors (including, but not limited to bevacizumab, sorafenib, thalidomide)
* Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus
* Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical therapy)
* Ongoing cardiac dysrhythmias grade >=2, atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec
* Major surgery, significant traumatic injury, or radiation therapy within 4 weeks of starting study treatment. An interval of at least 1week is required following minor surgical procedures, with the exception of placement of a vascular access device
* Grade 3 hemorrhage within 4 weeks of starting study treatment
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
* Known human immunodeficiency virus (HIV) infection or other serious infection
* Concomitant treatment with drugs having proarrhythmic potential including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide
* Concurrent use of the potent CYP3A4 inhibitors ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole and CYP3A4 inducers rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's Wort, and dexamethasone. Use of dexamethasone for study premedication is allowed. Grapefruit and grapefruit juice is prohibited. Alternative therapies should be used when available. If use of a potent CYP3A4 inhibitor or inducer is necessary, this must be approved by the Study Chair
* Known or suspected hypersensitivity to drugs containing Cremophor®EL (polyoxyethylated castor oil) such as cyclosporine or teniposide
* Pregnancy or breast-feeding. Negative serum pregnancy test is required within 7 days prior to first study treatment (Day 1, Cycle ) for all women of childbearing potential. Patients of childbearing potential must agree to use a birth control method that is approved by their study physician while receiving study treatment and for three months after the last dose of study treatment. Patients must agree to not breast-feed while receiving study treatment
* Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment
* History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease
* Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study
* Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible, but will have maintenance sunitinib interrupted while receiving radiation
* Any other disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that would cause reasonable suspicion of a disease or condition, that contraindicates the use of study drugs, that may increase the risk associated with study participation, that may affect the interpretation of the results, or that would make the patient inappropriate for this study
|
NCT_ID
NCT00887575
|
Study_NameNeoadjuvant Sunitinib With Paclitaxel/Carboplatin in Patients With Triple-Negative Breast Cancer
| 15,608 |
Study Objectives
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.
Conditions: Ovarian Neoplasms, Endocrine Gland Neoplasms, Neoplasms by Site, Neoplasms, Ovarian Diseases, Adnexal Diseases, Genital Diseases, Female
Intervention / Treatment:
DRUG: Trabectedin, DRUG: Dexamethasone
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Diagnosis of advanced epithelial ovarian cancer
* Progression or recurrence during or after platinum-containing regimen
* At least one measureable tumor lesion
* Adequate bone marrow, hepatic and renal function
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
* Known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone
* Pregnant or lactating women
* Known metastases (spread) of cancer to the central nervous system
* History of another neoplastic disease unless in remission for five years or more.
|
NCT_ID
NCT00050414
|
Study_NameA Study of Trabectedin in Patients With Advanced Ovarian Cancer
| 13,888 |
Study Objectives
The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
Conditions: Relapsed Hodgkin Lymphoma, Refractory Hodgkin Lymphoma
Intervention / Treatment:
DRUG: Camidanlumab Tesirine
Location: Poland, Germany, United States, Czechia, Spain, United Kingdom, Italy, Belgium, Canada, France, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Written informed consent must be obtained prior to any procedures.
* Male or female participant aged >= 18 years. (>= 16 years at US based sites)
* Pathologic diagnosis of classical Hodgkin lymphoma (cHL).
* Patients with relapsed or refractory cHL, who have received at least 3 prior lines of systemic therapy (or at least 2 prior lines in HSCT ineligible patients) including brentuximab vedotin and a checkpoint inhibitor approved for cHL (e.g., nivolumab or pembrolizumab). Note 1: Receipt of HSCT to be included in the number of prior therapies needed to meet eligibility.
* Measurable disease as defined by the 2014 Lugano Classification.
* Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available).
Note 1: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
Note 2: If a sufficient amount of tissue is not available, a fresh biopsy may be taken, provided the procedure is not deemed high-risk and is clinically feasible, and provided it is approved locally.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2.
* Adequate organ function as defined by Screening laboratory values within the following parameters:
1. Absolute neutrophil count (ANC) >= 1.0 × 103/μL (off growth factors at least 72 h).
2. Platelet count >= 75 × 103/μL without transfusion in the past 2 weeks.
3. ALT, AST, or GGT <= 2.5 × the upper limit of normal (ULN) if there is no liver involvement; ALT or AST <= 5 × ULN if there is liver involvement.
4. Total bilirubin <= 1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to <= 3 × ULN with direct bilirubin <= 1.5 × ULN).
5. Blood creatinine <= 3.0 × ULN or calculated creatinine clearance >= 30 mL/min by the Cockcroft-Gault equation.
Note: A laboratory assessment may be repeated a maximum of two times during the Screening Period to confirm eligibility.
* Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
* Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9.5 months after the last dose of Camidanlumab Tesirine. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6.5 months after the participants receives his last dose of Camidanlumab Tesirine.
Exclusion Criteria:
* Previous treatment with Camidanlumab Tesirine.
* Participation in another investigational interventional study. Being in follow-up of another investigational study is allowed.
* Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD25 antibody.
* Allogenic or autologous transplant within 60 days prior to start of study drug.
* Active graft-versus-host disease (GVHD), except for non-neurologic symptoms as a manifestation of mild (<= Grade 1) chronic GVHD.
* Post-transplantation lymphoproliferative disorders.
* Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary.
* History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]) (subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
* History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
* History of recent infection (within 4 weeks of Cycle 1, Day 1 [C1D1]) considered to be caused by one of the following pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Note: An influenza test and a pathogendirected SARS CoV-2 test (such as polymerase chain reaction) are mandatory and must be negative before initiating study treatment (tests to be performed 3 days or less prior to dosing on C1D1; an additional 2 days are allowed in the event of logistical issues for receiving the results on time).
* Participants known to be or having been infected with human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV), and require anti-viral therapy or prophylaxis. Note: Serology testing is mandatory for patients with unknown status.
* History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
* Failure to recover <= Grade 1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (except <= Grade 2 neuropathy or alopecia), due to previous therapy, prior to screening.
* Hodgkin lymphoma (HL) with central nervous system involvement, including leptomeningeal disease.
* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
* Breastfeeding or pregnant.
* Significant medical comorbidities, including uncontrolled hypertension (blood pressure [BP] >= 160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 3 months prior to screening, severe uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease.
* Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug, except shorter if approved by the Sponsor.
* Use of any other experimental medication within 30 days prior to start of study drug.
* Any live vaccine within 4 weeks prior to start of study drug and planned live vaccine administration after starting study drug.
* Congenital long QT (measure between Q wave and T wave in the electrocardiogram) syndrome, or a corrected QTc interval of >= 480 ms, at screening (unless secondary to pacemaker or bundle branch block).
* Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participants inappropriate for study participation or put the participant at risk.
|
NCT_ID
NCT04052997
|
Study_NameStudy to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
| 21,622 |
Study Objectives
This pilot clinical trial studies how well durvalumab before surgery works in treating patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.
Conditions: Human Papillomavirus Infection, Stage I Oral Cavity Squamous Cell Carcinoma, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage II Oral Cavity Squamous Cell Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage III Oral Cavity Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma, Stage IVA Oral Cavity Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Oral Cavity Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma
Intervention / Treatment:
BIOLOGICAL: Durvalumab, OTHER: Laboratory Biomarker Analysis, PROCEDURE: Therapeutic Conventional Surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologically or cytologically confirmed HNSCC of the oral cavity (OC; more than 90% patients have HPV negative cancer) or oropharynx (about 60 <= age <= 80% of patient have HPV positive cancer)
* Presence of radiologically of clinically documented disease. All radiology studies must be performed within 28 days prior to registration
* Any stage, considered candidates for surgery and planned for surgery either by robotic or by standard surgical technique
* Documentation of HPV tested by polymerase chain reaction (PCR) (resulted or pending)
* Willing to provide consent for an additional tissue biopsy for research purposes, to allow a part of their surgical tumor tissue to be utilized for research (in case tumor tissue has not already been saved in the tumor tissue bank), and to donate samples of blood and saliva collected weekly through the treatment
* All patients must have provided informed consent for correlative studies
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines
* At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as > or = 10 mm in the longest diameter (except lymph nodes, which must have a short axis > or = 15 mm) with CT or magnetic resonance imaging (MRI) or clinical measurement and that is suitable for accurate repeated measurements as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines
* Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred
* Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
* Platelet count >= 100 x 10^9/L
* Hemoglobin >= 9.0 g/dL
* Serum bilirubin =< 1.5 x upper limit of normal (ULN) (institutional upper limit of normal)
* Total bilirubin is less than or equal to ULN, except the case in which the elevated total bilirubin is not a sign of liver disease, such as the Gilbert Syndrome, in which case a Total Bilirubin less than or equal to 2X ULN is acceptable.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
* Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
* Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: >= 60 years and no menses for >= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry
* In accordance with National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) policy, protocol treatment is to begin within 2 working days of patient registration
* Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of American [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
* Age >= 18 years at time of study entry.
* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Exclusion Criteria:
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study
* Participation in another clinical study with an investigational product during the last 6 months (mo)
* Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
* Receipt of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within the last 6 mo (before the first dose of Durvalumab).
* Mean QT interval corrected for heart rate (corrected QT [QTc]) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
* Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
* Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
* Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1
* Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
* Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
* History of primary immunodeficiency
* History of allogeneic organ transplant
* History of hypersensitivity to durvalumab or any excipient
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
* Known history of previous clinical diagnosis of tuberculosis
* Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
* Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
* Patients with body weight <= 30 kg
* Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
|
NCT_ID
NCT02827838
|
Study_NameDurvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer
| 17,316 |
Study Objectives
RACING (RAmucirumab Combined wIth standard Nab-paclitaxel and Gemcitabine as first-line chemotherapy in patients with advanced pancreatic adenocarcinoma) trial is a Greek, investigator-initiated, single-arm, open-label phase Ib-II study. Patients with advanced cytologically or histologically proven pancreatic adenocarcinoma will be treated with a combination of Ramucirumab with Nab-paclitaxel and Gemcitabine (for a maximum of 8 cycles followed by Ramucirumab maintenance) until disease progression or excessive Adverse Events (AEs) or Investigator's decision or patient's refusal of further treatment or death, whichever comes first.
Conditions: Pancreatic Adenocarcinoma
Intervention / Treatment:
DRUG: Ramucirumab
Location: Greece
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Signed and dated written informed consent
* Histologically or cytologically proven pancreatic adenocarcinoma.
* Metastatic or locally advanced unresectable disease confirmed clinically/radiologically by CT-scan or MRI (Magnetic Resonance Imaging)
* No prior therapy for metastatic disease.
* At least one measurable or evaluable lesion as assessed by CT-scan or MRI according to RECIST v1.1
* Age 18 years,
* ECOG Performance status (PS) 0 <= age <= 1
* The patient has adequate hepatic function as defined by a total bilirubin 1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases)
* Female patients must commit to using reliable and appropriate methods of contraception during the trial until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another reliable contraceptive method during the trial until at least 6 months after the end of study treatment.
* Patients must have a low or intermediate risk of arterial or venous thrombotic events (Khorana risk score 0 <= age <= 2). Patients at a high VTE risk (Khorana RS3) are eligible if they receive LMWH prophylaxis (Appendix D).
Exclusion Criteria:
* The patient has pancreatic cancer with histology other than adenocarcinoma
* Prior therapy for metastatic disease. Adjuvant Gemcitabine is permitted if 6 or more months have elapsed from last cycle to date of relapse.
* Exclusive presence of bone metastasis only
* Concomitant unplanned antitumor therapy
* Treatment with any other investigational medicinal product within 28 days prior to study entry
* Other serious and uncontrolled non-malignant chronic disease
* The patient has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
* The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal antiinflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325mg/day) is permitted.
* The patient has experienced grade 3 <= age <= 4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis within 3 months prior to first dose of protocol therapy.
* Other concomitant or previous malignancy
* The patient has symptomatic congestive heart failure (CHF; New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia
* Bowel obstruction
* The patient has a prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation.
* Palliative radiation therapy within 4 weeks prior to registration
* The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy.
* High risk for arterial or venous thrombotic complications as depicted by a Khorana Risk Score higher than 2 and inability to receive prophylaxis with low molecular weight heparin.
|
NCT_ID
NCT03745430
|
Study_NameRAmucirumab Combined wIth Standard Nab-paclitaxel and Gemcitabine as First-line Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma
| 900 |
Study Objectives
Phase: Exploratory Study
Objectives: To collect drug bio-distribution data, begin collection of baseline and tumor/background imaging data, acquire experience to improve study design and the conduct of future studies
Design: Exploratory, open label, nonrandomized, multi-center study
Duration: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose
Procedures: Informed consent, collection of demographic information and medical history, physical examinations, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, blood sample for CA-IX assay, pre-dose and post-dose blood samples for metabolite analysis, dosing with \[F-18\]VM4-037, PET imaging scan, dosimetry estimation (normals), urine collections (normals), tumor immunohistochemistry with CA-IX biomarker, follow up to imaging to collect adverse events
Subjects: Approximately sixteen (16) adult subjects including four (4) healthy volunteers and twelve (12) cancer subjects who have confirmed or highly suspected diagnosis of head \& neck, lung, large solitary hepatic and renal cell cancer, as defined by protocol criteria
Conditions: Lung Cancer, Squamous Cell Carcinoma, Head and Neck Cancer, Hepatic Carcinoma, Renal Cell Carcinoma
Intervention / Treatment:
DRUG: [F-18] VM4-037
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
Normal Volunteers
* Subject is >= 18 years at the time of investigational product administration, and subject is male or female of any race / ethnicity
* Subject or subject's legally acceptable representative provides written informed consent
* Subject is capable of complying with study procedures
* Subject is capable of communicating with study personnel
* Subject must have renal and hepatic functions and haematological values as defined by laboratory results within defined ranges
Cancer Subjects
* Subject is >= 18 years at the time of the investigational product administration, and subject is a male or female of any race/ethnicity
* Subject or subject's legally acceptable representative provides written informed consent
* Subject is capable of complying with study procedures
* Subject is capable of communicating with study personnel
* Subject must have renal and hepatic functions and haematological values as defined by laboratory results within defined ranges
* Subject must have confirmed or highly suspected non-small cell lung cancer (local or with metastases), squamous cell carcinoma (advanced stages) of the head and neck whose primary origin was from oral cavity, oropharynx, hypopharynx or larynx (local or with metastases), large solitary hepatic carcinoma (primary or metastatic), or renal cell carcinoma (local or with metastases )
* Subject has an adequate size of tumors (>=2 cm) that should be amenable to imaging and biopsy for immunohistochemistry assay using CA-IX and/or hypoxia biomarkers
* Subject did not have any anticancer treatment intervention between [F-18]VM4 <= age <= 037 scan and sampling of biopsied tissue
* Subject is scheduled for a clinical [F-18]FDG PET scan within 14 days either prior to or after the investigational, [F-18]VM4 <= age <= 037 scan (with no anticancer treatment interventions between the two PET scans)
* Subject has a value of >= 60% at the time screening according to the Karnofsky Performance Status Scale
Exclusion Criteria:
Normal Volunteers
* Subject is < 18 years at the time of investigational product administration
* Subject is nursing
* Female subject is pregnant
* Subject is unable to remain still for duration of imaging procedure
* Subject has a significant hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by above lab tests in inclusion criteria
* Subject has previously received [F-18]VM4 <= age <= 037 at any time
* Subject has been involved in an investigative, radioactive research procedure within the past 14 days
* Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
* Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives
Cancer Subjects
* Subject is < 18 years at the time of investigational product administration
* Subject is nursing
* Female subject is pregnant
* Subject is unable to remain still for duration of imaging procedure
* Subject has significant hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by above lab tests in inclusion criteria
* Subject has previously received [F-18]VM4 <= age <= 037 at any time
* Subject has been involved in an investigative, radioactive research procedure within the past 14 days
* Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
* Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives
* Subject has had an anticancer treatment intervention between [F-18]VM4 <= age <= 037 scan and biopsied tissue sampling
* Subject has had an anticancer treatment intervention between [F-18]VM4 <= age <= 037 scan and [F-18]FDG scan
* Subject has an inadequate tumor sites or volume (< 2 cm) to allow for PET images and biopsy for immunohistochemistry
|
NCT_ID
NCT00884520
|
Study_NameAn Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037
| 2,279 |
Study Objectives
This randomized phase II trial is studying three different schedules of gemcitabine hydrochloride and tanespimycin to see how well they work in treating patients with stage IV pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells
Conditions: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer
Intervention / Treatment:
DRUG: gemcitabine hydrochloride, DRUG: tanespimycin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* Clinical stage IV disease
* No known brain metastases
* ECOG performance status 0 <= age <= 2
* Life expectancy >= 12 weeks
* Absolute Neutrophil Count (ANC) >= 1,500/mm³
* Platelet count >= 100,000/mm³
* Total bilirubin normal
* Aspartate aminotransferase (AST) <= 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase <= 2 times ULN (5 times ULN if liver metastases are present)
* Creatinine normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Ejection fraction > 40% by echocardiogram
* Patients who received prior anthracyclines must have a normal ejection fraction by echocardiogram
* Corrected QT interval (QTc) < 500 msec
* Pulse oximetry > 88% on room air at rest and after gentle exercise (according to Group Medicare Guidelines)
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tanespimycin (17-AAG) or gemcitabine hydrochloride
* No known allergy to eggs
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements
* No active ischemic heart disease within the past 12 months
* No history of uncontrolled dysrhythmias
* No congenital long QT syndrome
* No left bundle branch block
* No other significant cardiac disease, including any of the following:
* New York Heart Association class III or IV heart failure
* Myocardial infarction within the past year
* Poorly controlled angina
* Uncontrolled dysrhythmias
* History of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation >= 3 beats in a row)
* No clinically significant interstitial lung disease
* No symptomatic pulmonary disease requiring medication, including any of the following:
* Dyspnea
* Dyspnea on exertion
* Paroxysmal nocturnal dyspnea
* Significant pulmonary disease requiring oxygen*, including chronic obstructive/restrictive pulmonary disease
* No pulmonary or cardiac symptoms >= grade 2
* No history of cardiac or pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or vincristine)
* No prior chemotherapy for metastatic disease
* No prior radiotherapy to the chest
* No prior radiotherapy that potentially included the heart in the field (e.g.,mantle radiotherapy)
* More than 3 months since prior adjuvant chemotherapy or chemotherapy for locally advanced disease
* More than 3 weeks since prior radiotherapy
* No concurrent medications that prolong or may prolong QTc
* No concurrent antiarrhythmic drugs
* No concurrent prophylactic colony-stimulating factors
* No other concurrent investigational agents
* No other concurrent anticancer therapy
|
NCT_ID
NCT00577889
|
Study_NameGemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer
| 4,949 |
Study Objectives
Evolving paradigms in the treatment of adult ALL include the application of intense pediatric regimens to the treatment of adolescents and young adults (AYA) and the optimization of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the cure of patients. The Cancer and Leukemia Group B (CALGB) and the Children's Cancer Group (CCG) first asked whether AYA between the ages of 16 and 20 fared differently whether they were treated on pediatric protocols. The results of this study demonstrated that although the complete remission rates were identical for the AYAs treated on the CALGB and CCG trials, the AYAs had a 63% event-free survival (EFS) and 67% OS at 7 years on the CCG trials compared with 34% and 46%, respectively, on the CALGB trials.
High relapse and transplantation-related-mortality still remains great challenge for HSCT of adult ALL, which both range between 25% and 30%. Recently, risk-adapted indication and optimization of conditioning regimen are highlighted, which aiming to reduce TRM and relapse rate, respectively.City of Hope National Medical Center studied the substitution of etoposide (VP-16) for CY in the treatment of ALL patients receiving HCT. The result suggested that etoposide and TBI are associated with a decreased relapse rate following transplantation for ALL, compared with those receiving CY and TBI. Japanese and Germany reports pronounced the advantage of VP-16 in intensified regimen for adult ALL. On the same time, the investigators previous researches have confirmed the effect and safety of FA-intensified conditioning regimen on relapse and refractary leukemia.
Based on mentioned above, the investigators speculate that VP-16-intensified conditioning regimen could improve the outcome for adult ALL. The potential mechanism will be attributed to reduce MRD and promote GVL effect via providing enough time-window for immuno-reconstitution by high-dose preparative regimen.
Conditions: Acute Lymphoblastic Leukemia, Stem Cell Transplantation, Hematopoietic
Intervention / Treatment:
DRUG: TBI+CY+VP-16, DRUG: FA+TBI+CY+VP-16
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Age: 14 years to 65 years
* Diagnosis of High-risk acute lymphoblastic leukemia or standard-risk ALL in >=CR2
* Patient will receive allogeneic hematopoietic stem cell transplantation
* The informed consent form has been signed.
Exclusion Criteria:
* Patient with severe cardiac dysfunction with less than 50% EF
* Patient with severe lung dysfunction
* Patient with severe hepatic or renal dysfunction with more than 3 times the upper limit of normal range (ULN) of serum ALT or AST levels, or with more than 2 times the upper limit of normal range (ULN) of serum TBIL level or less than 40% of normal prothrombin time activity (PTA); or with more than 2 times the ULN of serum Cr
* Patient with severe active infection
* Patient with allergy history about suspected drug in conditioning regimen
* Patient with other conditions considered unsuitable for the study
|
NCT_ID
NCT01457040
|
Study_NameIntensified Conditioning Regimen With High-Dose-Etoposide for Allo-HSCT for Adult Acute Lymphoblastic Leukemia
| 8,673 |
Study Objectives
The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.
Conditions: Symptomatic Refractory Resistant Carcinoid Disease
Intervention / Treatment:
DRUG: Pasireotide, DRUG: Octreotide
Location: Israel, Germany, Poland, United States, Brazil, Spain, Sweden, Italy, Singapore, United Kingdom, Austria, Belgium, Canada, Norway, France, Argentina
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion criteria:
* Male or female patients aged 18 or greater
* Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues.
* Female patients of child bearing potential must have a negative pregnancy test at baseline.
* Patients for whom written informed consent to participate in the study has been obtained.
Exclusion criteria:
* Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization
* Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by HBA1C > 8%
* Patients with symptomatic cholelithiasis
* Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means.
Other protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT00690430
|
Study_NameEfficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease
| 3,903 |
Study Objectives
The primary aim of this study is to evaluate the effects of prospective patient education on patient satisfaction with administration of topical 5% 5-fluorouracil cream for the treatment of actinic keratosis involving the face, scalp, upper chest, dorsal hands and forearms. Specifically, this study aims to determine if prospective patient viewing of an educational video delineating treatment effects and expectations improves patient satisfaction and treatment completion rates.
Conditions: Actinic Keratoses
Intervention / Treatment:
OTHER: Video Group, OTHER: Verbal Group
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Subjects with a clinical diagnosis of actinic keratoses with at least 6 clinically-diagnosed actinic keratoses on the face, bald scalp, arms, upper chest, OR dorsal hands classified as grade I, mild (slightly palpable actinic keratoses, more easily felt than seen), and II, moderate (moderately thick hyperkeratotic actinic keratoses, easily felt).
Exclusion Criteria:
* Patients using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressor drugs, corticosteroids, retinoids, or investigational drugs within 4 weeks prior to enrollment.
* Patients who have been treated with any topical drug for actinic keratoses lesions less than 8 weeks prior to enrollment.
* Patients with invasive tumors within the treated area (e.g. invasive squamous cell carcinoma)
* Patients who have exhibited any dermatological disease within the treated or adjacent (3 cm distance) area at the time of screening.
* Patients who have known allergies to fluorouracil (5-FU).
|
NCT_ID
NCT02062853
|
Study_NameContinuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video
| 22,076 |
Study Objectives
The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The investigators hypothesize that depressed hospice and palliative care patients will be more likely to have a 50% reduction in scores on a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared to those patients who are taking a placebo plus an SSRI.
Conditions: Depression, Palliative Care, Cancer, Mental Disorder
Intervention / Treatment:
DRUG: Methylphenidate, DRUG: Placebo, DRUG: Selective Serotonin Uptake Inhibitor (SSRI)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: QUADRUPLE
|
Inclusion Criteria:
Inclusion:
* Either enrolled in the OHSU radiology/oncology clinic or VA palliative care, and living within 120 miles of the Portland VAMC.
* Life-limiting disease is any type of solid or blood cancer.
* Eighteen years of age or older.
* Life expectancy of 1 year or less as reflected by hospice admission or palliative care status. Although exact life expectancy can not be predicted, actively dying patients with estimated life expectancy of < 10 days are unlikely to be enrolled.
* Diagnosis of major depression disorder as determined by the Structured Clinical Interview for Diagnosis (SCID).
* Significant depressive cognitive symptomatology as determined by a MADRS greater than 19.
* Currently taking an SSRI but still depressed enough to meet eligibility criteria or not taking SSRI but depressed enough to start on SSRI.
* Willing and able to give informed consent to participate in this study as demonstrated by the MacArthur Competence Assessment Tool for clinical research.
* Speaks/understands English.
* For patients at home who cannot self-administer medications, has a caregiver who can assist with administering medication.
Exclusion Criteria:
Exclusion:
* Dementia or Delirium as determined by the Short Portable Mental Status Questionnaire (SPMSQ) score of less than 7.
* Diagnosis of delirium as determined by the Confusional Assessment Method (CAM).
* Any of the following Brief Psychiatric Rating Scale (BPRS) items rated 4 -, elated mood, suspiciousness, hallucinations, excitement, distractibility or motor hyperactivity.
* Severe insomnia.
* Severe anxiety.
* Significant suicidal ideation.
* History of current mental disorder in which depressive symptoms occur, but for which psychostimulants are contraindicated (schizophrenia and bipolar disorder will be based on history; active psychotic symptoms on selected BPRS items).
* History of stimulant abuse or other active, severe substance abuse.
* Contraindications to methylphenidate or an SSRI including significant cardiac arrhythmias; uncontrolled, severe hypertension; moderate-severe angina; seizure disorder; severe COPD; use of medications such as Levodopa, monoamine oxidase inhibitors, and lithium; diagnosis of narrow-angle glaucoma; or history of SSRI-induced hyponatremia,.
* Physical symptoms including increased blood pressure (DBP greater than 115, SBP greater than 180), pulse greater than 120, irregular pulse, or chest pain consistent with angina.
* Treatment for depression with a non-SSRI antidepressant including Bupropion and Venlafaxine during protocol.
* Known serum creatinine > 3.0, or severe liver disease as reflected by jaundice or hepatic encephalopathy.
* Unable to swallow pills, however if patient has gastrostomy tube or feeding tube in place the study medicines may be administered by this route. Pills may be poured into food.
* Receiving hospice care in a skilled nursing facility.
|
NCT_ID
NCT00129467
|
Study_NameMethylphenidate for Depressed Cancer Patients Receiving Palliative Care
| 8,610 |
Study Objectives
Breast cancer is rarely curable after metastasis, and the therapeutic options are limited. Interestingly, the host immune response is strongly predictive for the effect of chemotherapy in subgroups of patients with breast cancer. The aim is to release the brake on the immune response by use of ipilimumab, which blocks CTLA-4 and may deplete regulatory T cells, combined with nivolumab (anti PD1). Importantly, it is possible that non-responders to nivolumab/ipilimumab (nivo/ipi) can be turned responders by use of immunogenic chemotherapy.
Conditions: Breast Cancer, Hormone Receptor Positive Tumor, Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Ipilimumab, DRUG: Nivolumab, DRUG: Pegylated liposomal doxorubicin, DRUG: Cyclophosphamide
Location: Belgium, Norway
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Metastatic hormone receptor positive breast cancer (primary or recurrent), defined as ER+ >1% in metastatic biopsy (archival material or study biopsy) or cytology and HER2 negative in the last biopsy or cytology evaluable for HER2. HER2-analysis is to be perfomed according to national criteria.
* Adequate core or excisional study biopsy of a tumor lesion. Lesions in previously irradiated areas may only be used for the biopsy if the lesion has appared or progressed after radiation. No anti-tumor treatment is allowed between the time point for biopsy and study entry.
* Measurable metastatic disease according to RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Signed Informed Consent Form
* Women or men aged >= 18 years
* A minimum of 12 months from adjuvant/neoadjuvant chemotherapy with antracyclins to relapse disease
* A maximum of one previous line with chemotherapy in the metastatic setting
* Chemotherapy is considered as preferred treatment
* Previous endocrine and targeted therapy is allowed
* No use of systemic corticosteroids at study entry
* Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Female subjects of childbearing potential should agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year, during the treatment period and for at least 5 months after the last dose of study therapy.
* Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy
* Able to swallow and retain orally administered medication
* Adequate organ function as defined in Table 1
Exclusion Criteria:
* Malignancies other than breast cancer within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
* Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 8 weeks prior to randomization
* Known CNS disease, except for asymptomatic CNS metastases, provided all of the following criteria are met:
1. Measurable disease outside the CNS
2. Asymptomatic for CNS disease > 4 weeks
3. No ongoing requirement for corticosteroids as therapy for CNS disease
4. No radiation of brain lesions within 2 weeks prior to randomization
5. No leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites. Patients with indwelling catheters (e.g., PleurX®) are allowed
* Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to randomization
* Ionized calcium > 1.2 x UNL. The use of bisphosphonates is allowed
* Pregnant or breastfeeding
* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
* Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina Patients with a known left ventricular ejection fraction (LVEF) < 40% will be excluded. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
* Severe infection within 21 days prior to randomization, requiring hospitalization
* Received oral or IV antibiotics within 1 week prior to Cycle 1, Day 1. Patients receiving routine antibiotic prophylaxis (e.g., to prevent chronic obstructive pulmonary disease exacerbation or for dental extraction) are eligible
* Major surgical procedure within 21 days prior to randomization or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis. Placement of central venous access catheter(s) is not considered a major surgical procedure and is therefore permitted
* A history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity to any of the components of the investigational products
* A history of autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxin, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) are permitted provided that they meet all of the following conditions:
1. Rash must cover less than 10% of body surface area.
2. Disease is well controlled at baseline and only requiring low potency topical steroids
3. No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids)
* Undergone allogeneic stem cell or solid organ transplantation
* A history of idiopathic pulmonary fibrosis pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* A positive test for HIV
* Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
* Active tuberculosis
* Currently receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
* Received treatment with immune checkpoint modulators, including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibodies
* Received treatment with systemic immunostimulatory agents (including but not limited to interferons or IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
* Received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial
1. Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study
2. Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments performed using MRI
3. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed
* Received anti-cancer therapy (medical agents or radiation) within 2 weeks prior to study Cycle 1, Day 1. Palliative radiotherapy for bone lesions is allowed up to 7 days before start of therapy.
* A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator
* Known psychiatric or substance abuse disorders that would interfere with cooperation and the requirements of the trial
* Received a live vaccine within 30 days of planned start of study therapy, or is expected to receive such a vaccine while on therapy
a. Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
* Any reason why, in the opinion of the investigator, the patient should not participate
|
NCT_ID
NCT03409198
|
Study_NamePhase IIb Study Evaluating Immunogenic Chemotherapy Combined With Ipilimumab and Nivolumab in Breast Cancer
| 20,617 |
Study Objectives
This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
Conditions: Advanced Malignancies, Tumors
Intervention / Treatment:
DRUG: Patupilone/EPO906
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* 18 years or older
* World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
* Life expectancy of 3 months or more
* Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist
Exclusion Criteria:
* Severe and/or uncontrolled medical disease
* Known diagnosis of human immunodeficiency virus (HIV) infection
* Presence of any other active or suspected acute or chronic uncontrolled infection
* Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
* History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ
Other protocol-defined inclusion/exclusion criteria may apply.
|
NCT_ID
NCT00420524
|
Study_NameA Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
| 7,302 |
Study Objectives
This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of treatment are to control the lymphoma with the least amount of side effects. In many cases, MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced substance created to attach to proteins on the cancer cells, eventually destroying them. Chemotherapy is medicine that specifically destroys cancer cells.
The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab and Bendamustine have on this type of cancer. Patients in this study will either receive Ofatumumab alone, or Ofatumumab combined with Bendamustine.
Conditions: Mantle Cell Lymphoma
Intervention / Treatment:
BIOLOGICAL: Ofatumumab (This arm is closed), OTHER: Ofatumumab + Bendamustine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Untreated, non-transplant eligible, newly diagnosed mantle cell lymphoma with measurable disease as determined by CT, and bone marrow biopsy.
* Age > or = to 65 years or > 18 year and ineligible for HDT/ASCT.
* Subjects must not be candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant (ASCT), due to one or more of the following factors:
* Age >= 65 years
* Patients <65 years must be ineligible for HDT/ASCT on the basis of comorbidity, organ dysfunction or patient refusal for HDT/ASCT Comorbid disease, such as CAD, CHF, pulmonary dysfunction, liver or kidney dysfunction, precluding high dose therapy secondary to expected increased morbidity and mortality.
* poor performance status (KPS 70% or less)
* Ejection fraction <45%
* Impaired pulmonary function test with DLCO <50% expected
* Patient refusal
* Medical conditions which in the opinion of the treating physician and DMT preclude HDT/ASCT.
* Patients must have a serum creatinine clearance >= 40 mL/min (as per the Jelliffe method) or by 12-hour or 24-hour urine creatinine clearance.
* Patients must have ANC>1,000/mcl and Platelets>100,000/mcl (unless secondary to MCL).
* Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
* Negative serologies for Hepatitis B (HB) defined as a negative test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if negative, patient may be included but must undergo HBV DNA PCR testing at the beginning of treatment and throughout treatment duration, at least every 2 months. In addition patients will require treatment with Entacavir .5mg po qday per MSKCC institutional guidelines.
* No active co-morbid cardiac condition such as active CHF or CAD.
* KPS performance >= 70%.
* Histologically confirmed mantle cell lymphoma classified according to WHO criteria confirmed at MSKCC.
* No prior treatment for mantle cell lymphoma with the exception of corticosteroids for 7 days or less or 1 course of involved-field radiation.
* No prior malignancies within 5 yrs, unless treated early stage breast cancer, treated carcinoma in situ of the cervix, resected skin malignancies, or treated prostate cancer.
* Women who are pre-menopausal must have a negative serum pregnancy test. Subjects must agree to use appropriate contraception until 4 weeks after the completion of chemotherapy.
* Patients must be HIV negative, and have negative serologies for Hepatitis C.
Exclusion Criteria:
* Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, hepatic involvement by MCL, or stable chronic liver disease per investigator assessment).
* Known pregnancy or breast-feeding.
* Medical illness unrelated to MCL within the prior one month that will preclude administration of chemotherapy safely. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, active congestive heart failure, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis.
|
NCT_ID
NCT01437709
|
Study_NameOfatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant
| 17,574 |
Study Objectives
Phase I trial to study the effectiveness of BMS-214662 in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: BMS-214662, OTHER: laboratory biomarker analysis, OTHER: pharmacological study
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Metastatic or inoperable malignancy, other than leukemia or a primary CNS tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies
* Life expectancy >= 2 months
* ECOG performance status 0 <= age <= 1
* ANC >= 1,500/mm^3
* Platelets >= 100,000/mm^3
* SGOT and SGPT =< 2.5 times the upper limit of normal (ULN)
* Total bilirubin =< ULN
* Serum creatinine =< ULN
* Calculated or measured creatinine clearances (Cockcroft-Gault formula) >= 50 ml/minute
* >= 3 weeks since major surgery
* >= 4 weeks since chemotherapy or radiation therapy
* No uncontrolled serious medical or psychiatric illness
* Women of childbearing potential must not be pregnant or lactating; all women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L of beta-HCG) within 72 hr prior to receiving the study medication; BMS 214662 has antiproliferative effects which may be harmful to the developing fetus or nursing infant
* Fertile males and females must use adequate contraception
* Signed informed consent
Exclusion Criteria:
* Any history of clinically significant atrial or ventricular arrhythmias, any history of second or third degree heart block, or prolonged QTc interval (greater than 450 ms) on electrocardiogram
* Active brain metastases including evidence of cerebral edema by CT scan or MRI, or progression from prior imaging study, any requirement for steroids, or clinical symptoms of/from brain metastases
* Received any drugs within 7 days prior to receiving study drug therapy, which are known to be substrates of cytochrome P450 <= age <= 3A4 (CYP3A4)
* Patients should not receive concurrent therapy with known CYP3A4 substrates while on study and for at least 1 week following the last dose of BMS-214662; this is due to the CYP3A4 inhibitory potential of BMS-214662; a representative list of commonly prescribed known CYP3A4 substrates includes: terfenadine, astemizole, triazolam, midazolam, cisapride, bepridil, rifabutin, simvastatin, lovastatin, and propafenone
* Patients receiving therapy with BMS-214662 should not receive concomitant therapy with NSAIDs or other potentially nephrotoxic medications for at least 2 days before and after administration of BMS-214662
* Patients with known pre-existing renal disease are not eligible
|
NCT_ID
NCT00006242
|
Study_NameBMS-214662 in Treating Patients With Advanced Solid Tumors
| 12,065 |
Study Objectives
The purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. We will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: thalidomide, DRUG: placebo
Location: Norway
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Patients with multiple myeloma in need of treatment
Exclusion Criteria:
* Previous treatment against multiple myeloma
* Need of high dose chemotherapy with autologous stem cell support
* Women in fertile age
* Psychiatric disease or mental reduction leading to lack of cooperation
* Lack of consent
* Life expectancy below 3 months
* Active cancer of other etiology
|
NCT_ID
NCT00218855
|
Study_NameThalidomide to Patients With Previously Untreated Multiple Myeloma
| 13,770 |
Study Objectives
To assess emetic responses to multi-day doses of Palonosetron and Aprepitant and low dose dexamethasone +/- Prochlorperazine among patients with multiple myeloma and lymphoma undergoing autologous HSCT utilizing the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Conditions: Myeloma, Plasma-Cell, Lymphoma, Malignant
Intervention / Treatment:
DRUG: Palonosetron, DRUG: Aprepitant, DRUG: Dexamethasone
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with multiple myeloma and lymphoma deemed by the treating institution to be candidates for high dose chemotherapy and autologous hematopoietic stem cell transplant.
* Both males and females are eligible.
* Patients should be 18 years; multiple myeloma patients up to age 75 and lymphoma patients up to age 65 are eligible.
* Patients with Karnofsky performance status of 60% or better.
* Patients should have at least 2.5 x 106 cyropreserved CD34+ cells per kilogram available for transplantation.
* Patients with adequate bone marrow function as defined as ANC >=1000 cells/mm3 , platelet >= 75,000 cells/mm3.
* Lymphoma patient must have adequate renal function as defined by a calculated creatinine clearance of 50% measured in ml/min.
* The criteria for renal function does not apply for multiple myeloma patients. Multiple myeloma patients undergoing hemodialysis are eligible.
* All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater or equal to 48% within 42 days prior to registration.
* Patients must have adequate pulmonary function as defined by room air pulse oximetry equal to or greater than 93%, and pulmonary function tests (FEV1 and DLCO) equal to or greater than 50% of predicted values.
* Patients with adequate hepatic function as defined by serum bilirubin lower than 2.5 mg/dL and liver function tests to not exceed greater than 1.5x of the institutions ULN.
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with the institutional and federal guidelines.
* Patients must be able to complete the anti-emesis assessment questionnaire. A Spanish questionnaire will be available for Hispanic-speaking patients.
Exclusion Criteria:
* Patients with nausea and have emetic episodes, and are receiving any anti-emetic medication taken within 24 hours of receiving antibiotics.
* Active infection involving intravenous antibiotics.
* Patients with known active hepatitis B and/or hepatitis C infections are excluded.
* Patients with known HIV infection.
* Primary or secondary brain neoplasms with increased intracranial pressure.
* Received intrathecal chemotherapy within 24 hours of first dose of conditioning chemotherapy.
* Patients who are nursing mothers or pregnant. Females of childbearing age are required to have a negative serum B-HCG pregnancy test 24 hours prior to enrollment on the study.
* Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years.
* Patients with uncontrolled medical problems such as diabetes mellitus, cardiac (i.e. congestive heart failure, coronary heart disease, arrhythmias), pulmonary hepatic and renal disease unless renal insufficiency is felt to be secondary to multiple myeloma,
* Myocardial infarction within 6 months of enrollment in the study.
* Major surgery within 4 weeks of enrollment.
* Morbid obesity (BMI>40)
* Patients with psychiatric or central nervous systems disorders interfering with ability to comply with study protocol.
* Patients receiving therapeutic anticoagulant therapy for venous thromboembolic episode or other hypercoaguable states. Coumadin at 1 mg as prophylaxis for central venous catheter is allowed.
* Known hypersensitivity to 5-HT3 antagonists and Aprepitant and their components.
* Use of non-prescription and herbal-type medications within 72 hours of enrollment on the study. Their use are not allowed during the study. Multivitamins, nutritional supplements such as Boost, and other electrolyte replacements are allowed.
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NCT_ID
NCT00600353
|
Study_NameMulti-day Doses in Prevention of Nausea and Emesis
| 21,940 |
Study Objectives
Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.
Conditions: Curative Breast Cancer Surgery, Inflammatory Positive/Negative Status, Pre Surgical Incision Administration
Intervention / Treatment:
DRUG: Ketorolac 30 mg IV, DRUG: Placebos
Location: Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
Written informed Consent age : 18 <= age <= 85 years weight: 50 <= age <= 100 kg Neutrophils / Lymphocytes ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes
Exclusion Criteria:
Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )
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NCT_ID
NCT01806259
|
Study_NameKetorolac in Breast Cancer Surgery
| 11,912 |
Study Objectives
The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.
Conditions: Advanced Breast Cancer
Intervention / Treatment:
DRUG: Fulvestrant, DRUG: Anastrozole, DRUG: Fulvestrant
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* postmenopausal women with confirmation of breast cancer
* objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer
Exclusion Criteria:
* presence of life-threatening metastatic visceral disease
* previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
* more than 1 prior endocrine medical treatment for advanced breast cancer .
|
NCT_ID
NCT00635713
|
Study_NameSecond Line Breast Cancer Trial
| 7,786 |
Study Objectives
Primary objective To investigate the safety and tolerability profile of 68Ga- NODAGA-SNA006 in patients with solid tumors; To investigate the radiation absorbed dose characteristics of 68Ga-NODAGA-SNA006 in patients with solid tumors; To investigate the distribution profile of 68Ga-NODAGA-SNA006 in patients with solid tumors. Secondary objectives To investigate the optimal administration dose and radiation safety profile of 68Ga-NODAGA-SNA006; To investigate the PET imaging characteristics and high-quality imaging time window of 68Ga-NODAGA-SNA006 in patients with solid tumors; To explore the correlation between PET imaging characteristics of 68Ga-NODAGA-SNA006 binding to CD8 and histological CD8 expression characteristics; To explore peripheral blood T lymphocyte differentiation (CD8, CD4, CD3, etc.) in patients with solid tumors.
Conditions: Solid Tumor
Intervention / Treatment:
BIOLOGICAL: 68Ga-NODAGA-SNA006
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age 18 <= age <= 70 years (including boundary values);
* Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
* Performance status (ECOG) score 0 <= age <= 1 points (see Appendix 1 for details);
* Basal heart rate 60 <= age <= 100 beats/min (including boundary values);
* Blood pressure measurement < hypertension grade 1 level (including a history of hypertension, systolic blood pressure < 140 and diastolic blood pressure < 90 mmHg by exercise or drug treatment);
* Patients with confirmed solid tumors;
* Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
* Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FDG PET/CT results are acceptable);
* Patients with immunohistochemical CD8 results within the past month;
Exclusion Criteria:
* Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment.
* Those who have extremely poor nutritional status and cannot tolerate the trial
* Those with comorbid major diseases or other malignancies (except those that have healed by one year or do not require additional treatment)
* Those with known severe allergy to SNA006, similar drugs or excipients. Specialized conditions
* Patients who have undergone previous splenectomy or splenic disease such as hypersplenism or splenomegaly
* Patients with brain metastases.
* Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies
* Patients who have not recovered from a serious infection
* Patients with drug/alcohol abuse, severe mental disorders
* Those with claustrophobia, emotional instability, acute persistent spasticity or inability to keep both arms up and lying flat for 15 <= age <= 30 minutes
* Those who have participated in any other clinical trial within 3 months prior to screening
* Women who are pregnant or breastfeeding.
* Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.
|
NCT_ID
NCT05126927
|
Study_NameA PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors
| 1,647 |
Study Objectives
The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.
Conditions: MDS, Myelodysplastic Syndromes, Thrombocytopenia
Intervention / Treatment:
DRUG: Placebo, BIOLOGICAL: AMG 531 (Romiplostim), DRUG: Azacitidine, DRUG: Decitabine
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria: - Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification - Low, Intermediate-1 or Intermediate-2 risk category MDS using the IPSS (International Prognostic Scoring System) - Planned to receive either azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20 mg/m2 by intravenous administration each day for 5 days for at least 4 cycles Exclusion Criteria:
* Prior exposure to >3 cycles hypomethylating agents
* Prior history of leukemia or aplastic anemia
* Prior history of bone marrow transplantation
* Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ³ 3 years before randomization
* Active or uncontrolled infections
* Unstable angina, congestive heart failure [NYHA (New York Heart Association) > class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
* History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year
* History of venous thrombosis that currently requires anti-coagulation therapy
* Received IL-11 within 4 weeks of screening
* Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication
* Have previously received any other thrombopoietic growth factor
|
NCT_ID
NCT00321711
|
Study_NameDetermination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents
| 20,036 |
Study Objectives
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.
The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Anastrozole, DRUG: Tamoxifen
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologically proven HR+ invasive breast cancer
* Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
* Postmenopausal woman
Exclusion Criteria:
* clinical evidence of metastatic disease
* previous adjuvant hormonal therapy for breast cancer
* liver diseases
|
NCT_ID
NCT00537771
|
Study_NameLiver Safety Under Upfront Arimidex vs Tamoxifen
| 20,782 |
Study Objectives
The purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.
In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.
Conditions: Neoplasm
Intervention / Treatment:
DRUG: PTK787/ZK222584
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age > 18
* Zubrod performance status of 0 - 2
* Histological or cytological diagnosis of pancreatic adenocarcinoma
* Measurable or evaluable disease determined as per RECIST criteria
* Life expectancy > 12 weeks
* Written informed consent
* Patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease.
Exclusion Criteria:
* Islet cell or neuroendocrine carcinomas of the pancreas.
* History or presence of central nervous system disease.
* Patients with a history of another primary malignancy < 5 years
* Prior chemo therapy < 21 days prior to registration.
* Prior biologic or immunotherapy < 14 days prior to registration
* Prior full field radiotherapy < 28 days or limited field radiotherapy < 14 days prior to registration.
* Major surgery < 28 days prior to registration.
* Patients who have received investigational drugs < 28 days prior to registration.
* Prior therapy with anti-VEGF agents.
* Pleural effusion or ascites that causes respiratory compromise.
* Female patients who are pregnant or breast feeding.
|
NCT_ID
NCT00226005
|
Study_NamePTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
| 20,478 |
Study Objectives
Estimation of the Maximum tolerated dose (MTD) and/or Recommended dose (RD) of LDK378 as a single agent when administered orally to Japanese patients with tumors characterized by genetic alterations in anaplastic lymphoma kinase (ALK)
Conditions: Tumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)
Intervention / Treatment:
DRUG: LDK378
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
* Only patients with tumors characterized by genetic alterations in ALK. For non-small cell lung cancer (NSCLC), an ALK translocation must be detected by Fluorescent in situ hybridization (FISH) in >=15% of tumor cells. Local site documented results on ALK alteration are acceptable for enrollment of the patients. Central confirmation of local results is not required.
--Eastern Cooperative Oncology Group (ECOG) performance status grade <= 2
* Adequate organ function
* Dose-expansion part: Patients must have NSCLC that has progressed since prior therapy with alectinib. Alectinib must have been the only prior ALK inhibitor received by the patient prior to trial entry.
Exclusion Criteria:
* Patients with symptomatic Central Nerve System (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control their CNS disease
* Patients with unresolved nausea, vomiting or diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
* Other concurrent severe and/or uncontrolled medical conditions
* Patients who have been treated with chemotherapy or biologic therapy or other investigational agent < 2 weeks prior to starting the daily dosing of the study drug for compounds with a half-life <= 3 days, and < 4 weeks prior to starting the daily dosing of the study drug for compounds with a prolonged half-life (< 6 weeks for patients that received nitrosoureas or mitomycin-C)
* Unresolved toxicity greater than CTCAE grade 1 or unstable toxicity from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia), or incomplete recovery from previous surgery, unless agreed by Novartis and the Principal Investigator and documented
* Patients who have received radiotherapy to lung within 4 weeks prior to starting the daily dosing of the study drug or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites radiotherapy to a large volume (including whole brain radiotherapy) < 2 weeks prior to starting the daily dosing of the study drug, and patients who have received radiotherapy to a small volume (including stereotactic radiotherapy to the CNS) < 3 days prior to starting the study drug.
Other protocol-defined inclusion/exclusion criteria may apply.
|
NCT_ID
NCT01634763
|
Study_NameStudy of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)
| 4,351 |
Study Objectives
Patients who need major head \& neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists in the optimal antibiotic regimen
Conditions: Laryngeal Cancer
Intervention / Treatment:
DRUG: cefazolin
Location: Iran, Islamic Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:e.
* Patients eligible to be included in this trial were those who histologically confirmed squamous cell carcinoma of larynx and hypopharynx and they were candidate of total or partial laryngectomy with or without neck dissection and with negative history of neck or laryngeal radiation were included in this study.
Exclusion Criteria:
* Patients having recurrences or another primary tumor, and those who underwent reconstruction with a flap were excluded from the study, because they had been submitted to prolonged antibiotic administration. Also cases with Diabet mellitus and Immune suppression or tumor types other than squamous cell carcinoma were excluded from the study.
* In addition, the following exclusion criteria were taken into account: pregnancy, hypersensitivity to penicillins or cephalosporins, patients who received a systemic antibiotic drug within one week prior to the planned procedure, those who had clinical or laboratory evidence of a preexisting infection or had serious systemic renal disease.
|
NCT_ID
NCT00467948
|
Study_NameComparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
| 128 |
Study Objectives
The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: Vincristine Sulfate Liposomes Injection, DRUG: Dexamethasone
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt's subtypes) with measurable disease.
* Performance status <=3 (ECOG).
* All ages are eligible. Those aged >= 12 years may be counted towards the MTD in the Phase I portion of the trial. Pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course).
* Adequate liver function (bilirubin <=2 x upper limit normal), and renal function (creatinine <=2 x upper limit normal).
* Negative pregnancy test in females of childbearing potential.
* Patients with prior history of stem cell transplant are eligible if they meet all other eligibility requirements.
Exclusion Criteria:
* Active serious infection not controlled by oral or intravenous antibiotics.
* Treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the Investigator.
* Concurrent treatment with other anti-cancer agents other than dexamethasone.
* Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with CNS neuropathy limiting evaluation of study drug. Patients with controlled CNS disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the Principal Investigator. Lumbar puncture not required in asymptomatic patients.
* Prior history of Grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent Grade 2 or greater active neuropathy.
* History of active neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
* Prior history of hypersensitivity reactions to vincristine or any of the other components of VSLI.
* Pregnant and/or lactating women; or fertile men or women not willing to use contraception.
|
NCT_ID
NCT00144963
|
Study_NameLiposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
| 2,932 |
Study Objectives
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief.
Conditions: Oral Pain, Oral Ulcers, Oral Tumors
Location: Colombia, Costa Rica, United States
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Patients who use plants to relieve oral pain, inflammations, ulcers, and tumors
|
NCT_ID
NCT00200837
|
Study_NameEthnopharmacological Studies in Oral Medicine
| 18,294 |
Study Objectives
This is a pilot study of pembrolizumab-based therapy in previously treated extrapulmonary poorly differentiated neuroendocrine carcinoma
Conditions: High Grade Malignant Neuroendocrine Carcinoma (Diagnosis)
Intervention / Treatment:
DRUG: Pembrolizumab, DRUG: Irinotecan, DRUG: Paclitaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Be willing and able to provide written informed consent for the trial.
* Be at least 18 years on day of signing informed consent.
* Have a histologically proven locally advanced or metastatic high grade (G3) poorly differentiated neuroendocrine carcinoma (NEC).
1. Includes small cell and large cell neuroendocrine carcinoma of unknown primary or any extrapulmonary site (and poorly differentiated NEC, not otherwise specified)
2. Includes neuroendocrine prostate cancer (de novo or treatment-emergent) of prostate if small cell or large cell histology (histologic evidence of both adenocarcinoma and neuroendocrine carcinoma may be present in same patient).
3. Other mixed tumors, e.g. mixed neuroendocrine neoplasms (MINENs) with NEC plus adenocarcinoma, squamous or acinar cell component are allowed if the high grade (small or large cell) NEC component comprises >50% of the original sample or subsequent biopsy.
* Have progressed during or after completion of first line systemic chemotherapy.
1. No limit to the number of prior chemotherapy regimens.
2. Early progression on/after adjuvant chemotherapy counts as firstline therapy.
* Have at least one measurable disease based on RECIST 1.1.
* Patients must agree to have a biopsy of primary tumor or metastatic tissue at baseline, and there must be a lesion that can be biopsied with acceptable clinical risk (as judged by the investigator).
1. Patients with unsuccessful baseline biopsies may undergo an additional biopsy attempt (at the same or a different site, determined by the investigator).
2. For patients with an intact primary and no metastatic site that can be safely biopsied, biopsy of the primary is acceptable, but must be approved by the principal investigator.
3. Baseline tumor biopsy may be omitted if the tumor is inaccessible and/or a biopsy is not thought to post exceptionally high procedural risk due to location or other factors
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Have a life expectancy of greater than 3 months.
* Demonstrate adequate organ function, all screening labs should be performed within 14 days of treatment initiation.
* Absolute neutrophil count (ANC) >=1,500 /microliter (mcL)
* Platelets >=100,000 / mcL
* Hemoglobin >= 9 g/dL or >=5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
* Serum creatinine OR Measured or calculated creatinine clearance (CrCl) (Creatinine clearance should be calculated per institutional standard. Glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl <=1.5 X upper limit of normal (ULN) OR >=60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
* Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN
* aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) <=2.5 X ULN OR <= 5 X ULN for subjects with liver metastases
* Albumin >2.5 g/dL
* International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
* Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion Criteria:
* Has Merkel cell carcinoma, small cell lung carcinoma, or large cell NEC of lung
* Intermediate grade neuroendocrine tumors are excluded
* Well differentiated Grade 3 neuroendocrine tumors are excluded
* Metastatic high-grade prostate carcinoma with evidence of focal neuroendocrine differentiation on prostate biopsy (e.g., positive chromogranin staining by immunohistochemistry) without small cell or large cell NEC morphology are excluded, as are neuroendocrine prostate cancers with phenotype intermediate between adenocarcinoma and small cell
* Atypical and typical bronchial carcinoids and well differentiated G1 and G2 gastroenteropancreatic (GEP) neuroendocrine tumors (NET) (GEP NETs) are excluded.
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has a diagnosis of immunodeficiency
* Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Physiologic doses of steroids (e.g. =< 10 mg prednisone/day or equivalent) are allowed
* Has a known history of active Bacillus Tuberculosis (TB).
* History of or high suspicion of Gilbert's disease (safety run-in, Part B only)
* Hypersensitivity to pembrolizumab or any of its excipients.
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* Documented progression on and/or intolerance/hypersensitivity to both paclitaxel and irinotecan (Part B only)
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent.
* Note: Subjects with <= Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
* Concurrent somatostatin analog therapy is allowed (for control of hormone excess) provided patient has been on stable dose for at least two months and tumor progression has been documented
* Continuation of androgen deprivation therapy (ADT) allowed for patients with neuroendocrine prostate cancer (in the setting of castration-resistant prostate cancer, CRPC)
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with asymptomatic suspected brain metastases (or small lesions of uncertain significance) <1 cm that do not require focal therapy are eligible. (Follow up imaging will be allowed on study, and focal radiation with continuation of protocol therapy allowed if there is progressive disease in the brain and systemic imaging shows stable disease/response).
- Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks and any neurologic symptoms have returned to baseline), they have no evidence of new or enlarging brain metastases (confirmed by imaging within 28 d of the first dose of trial treatment), and they are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has a history of (non-infectious) pneumonitis/ interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-Programmed Death 1 (PD-1), anti-Programmed Death Ligand 1 (PD-L1), or anti-PD-L2 agent.
* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Has known active Hepatitis B virus (e.g., HBsAg reactive) or Hepatitis C virus (HCV)(e.g., HCV RNA [qualitative] is detected).
* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
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NCT_ID
NCT03136055
|
Study_NamePembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
| 13,740 |
Study Objectives
Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a small growth called an adenoma in the parathyroid glands) is an increasingly significant medical and public health condition.
Surgery is the only effective management for primary hyperparathyroidism. However; it is sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of tumors.
SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing the tumor. This, however, is a challenge because the parathyroid glands usually are located close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the parathyroid but not in the thyroid.
A more sensitive and specific radiotracer/tracking agent would markedly improve the investigators ability to identify parathyroid tumors preoperatively, and thus offer more patients a minimally invasive parathyroidectomy.
anti-3-\[18F\]FACBC is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments, anti-3-\[18F\]FACBC has shown uptake in parathyroid cells greater than thyroid cells. Therefore, the investigators think that this radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi.
The primary aim of this study is to determine if anti-3-\[18F\]FACBC PET-CT demonstrates uptake within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will undergo PET-CT using anti-3-\[18F\]FACBC in addition to the standard 99mTc sestamibi scanning and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced CT scanning. Since all these patients undergo surgery routinely, the investigators will then compare findings at surgery to those of the anti-3-\[18F\]FACBC PET-CT to determine if this radiotracer is worthy of further study in a more comprehensive experiment.
Conditions: Parathyroid Disease
Intervention / Treatment:
DRUG: FACBC
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients must be 18 years or older.
* Patients will have biochemical and/or clinical evidence of primary hyperparathyroidism and be a surgical candidate for definitive parathyroid surgery .
* Ability to lie still for PET scanning
* Patients must be able to provide written informed consent
Exclusion Criteria:
* Age less than 18.
* Inability to lie still for PET scanning.
* Cannot provide written informed consent.
* History of secondary hyperparathyroidism.
* Positive serum or urine pregnancy test within 24 hours of imaging
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NCT_ID
NCT01574287
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Study_NameAnti-3-[18F]FACBC Imaging of Parathyroid Adenomas
| 20,382 |
Study Objectives
This phase Ib/II trial studies the side effects and best way to give pembrolizumab with combination chemotherapy and radiation therapy before surgery and to see how well it works in treating adult patients with gastroesophageal junction or gastric cardia cancer that has spread from where it started to nearby tissue and can be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, combination chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Conditions: Gastric Cardia Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Stage IB Gastric Cancer AJCC v7, Stage II Gastric Cancer AJCC v7, Stage IIA Gastric Cancer AJCC v7, Stage IIB Gastric Cancer AJCC v7, Stage IIIA Gastric Cancer AJCC v7, Stage IIIB Gastric Cancer AJCC v7
Intervention / Treatment:
DRUG: Carboplatin, PROCEDURE: Computed Tomography, DRUG: Fluorouracil, OTHER: Laboratory Biomarker Analysis, DRUG: Leucovorin Calcium, DRUG: Oxaliplatin, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, PROCEDURE: Positron Emission Tomography, RADIATION: Radiation Therapy, PROCEDURE: Therapeutic Conventional Surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma involving the gastroesophageal junction or gastric cardia
* Central pathology review to determine evaluability of archived esophagogastroduodenoscopy (EGD)/biopsy sample
* NOTE: If archived sample was collected > 8 weeks prior to pre-registration (reg), is not available in a timely manner, or was collected outside of Mayo Clinic and considered unevaluable, then baseline EGD with primary tumor biopsy at Mayo Clinic must be performed unless clinically contraindicated; patient is allowed to enroll regardless of whether this Mayo Clinic tissue sample is evaluable; (Only 1 EGD with primary tumor biopsy performed at Mayo Clinic =< 8 weeks prior to pre-reg is required)
* NOTE: For both archival or newly obtained tissue, only biopsies are adequate (fine needle aspiration [FNA] is not adequate)
* Willing to provide mandatory tissue samples for research purposes
* Baseline imaging with an fludeoxyglucose (FDG)-positron emission tomography (PET) scan negative for distant metastatic disease must be obtained =< 28 days prior to registration
* Surgically resectable (T2N0, T3N0, Tany with node positivity, M0), as determined by endoscopic ultrasound (EUS) and the following minimum diagnostic work-up:
* Whole-body PET/computed tomography (CT) (PET/CT of skull base to mid-thigh is acceptable)
* EUS =< 21 days prior to registration
* NOTE: Patients may have regional adenopathy including para-esophageal, gastric, gastrohepatic and celiac nodes; if celiac adenopathy is present, it must be < 2 cm
* NOTE: If patient unable to have PET/CT then CT chest/abdomen/pelvis with contrast (preferred) or MRI chest/abdomen/pelvis with contrast
* Surgical consultation at enrolling site to confirm that patient will be able to undergo curative resection after completion of chemoradiation =< 56 days prior to registration
* Tumor is amenable to standard resection and reconstruction
* Radiation oncology consultation at enrolling site to confirm that disease can be encompassed in a radiotherapy field =< 56 days prior to registration
* NOTE: Radiotherapy quality assurance rapid review must be performed before the first fraction of radiation therapy (RT) is administered; if RT constraints cannot be met, the patient will be removed from the protocol prior to treatment
* Consultation with a medical oncologist at enrolling site =< 56 days prior to registration, with determination that treatment with neoadjuvant chemoradiotherapy with weekly carboplatin and paclitaxel is considered acceptable
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate oral intake and nutritional status without current or likely need for enteral or parenteral feeding during chemoradiation or the preoperative period
* Pre-treatment pulmonary function tests (PFTs), collected =< 90 days prior to enrollment, must show forced expiratory volume in one second (FEV1) > 60% of predicted
* Adequate organ function =< 21 days prior to registration:
* Aspartate transaminase (AST) level =< 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) =< 3 x upper limit of normal (ULN)
* Total bilirubin level of =< 1.5 x ULN
* Creatinine level =< 1.2 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above or below the institutional normal
* Hemoglobin (Hgb) >= 9 g/dl without transfusion or epoetin dependency (=< 7 days prior to assessment)
* Absolute neutrophil count >= 1.5 x 10^9/L
* Platelets >= 100 x 10^9/L
* Albumin >= 2.5 g/dl
* Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
* NOTE: Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
* Female patients of childbearing potential must have a negative urine or serum pregnancy test =< 7 days prior to registration
* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
* NOTE: Abstinence is acceptable if this is the established and preferred method of contraception for the subject
* Provide signed written informed consent
* Willing to return to enrolling institution for follow-up
* Willing to provide mandatory tissue and blood samples for research purposes
* NOTE: Patients must be willing to provide at the time surgical resection; for patients who do not undergo surgery, any on-study tumor biopsy obtained for clinical purposes subsequent to the baseline biopsy must also be available for analysis
Exclusion Criteria:
* Tumor characteristics - any of the following are excluded:
* Evidence of distant metastases
* Tumors whose location is restricted to the tubular esophagus (i.e., without involvement of the GEJ or cardia)
* Tumors whose proximal end are at the level of the carina or higher
* Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
* Palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular nodes, or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension)
* T1N0M0, T4Nany, or in situ carcinoma
* Tumor must not extend 5 or more cm into the stomach
* Received prior treatment or receiving current treatment for this malignancy
* Prior radiation to chest or abdomen, or to > 30% of the marrow cavity
* Inadequate caloric or fluid intake whereby there is a current or likely future need for enteral or parenteral feeding during chemoradiation or the preoperative period
* Major surgery =< 4 weeks prior to registration
* Active autoimmune disorders, including patients known to be human immunodeficiency virus (HIV) positive, or those requiring chronic steroid administration (excluding inhaled steroids)
* Uncontrolled diabetes (i.e., will interfere with the performance of the FDG PET/CT scans)
* Prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine, or study drugs involved in this protocol, or to a monoclonal antibody or prior hypersensitivity to platinum-containing agents
* Heart conditions - any of the following:
* Any atrial fibrillation =< 3 months prior to registration
* Unstable angina =< 12 months prior to registration
* Prior symptomatic congestive heart failure
* Documented myocardial infarction =< 6 months prior to registration (pretreatment electrocardiogram [ECG] evidence of infarct only will not exclude patients)
* Prior significant ventricular arrhythmia requiring medication
* Prior 2nd or 3rd degree heart block or other types of clinically significant conduction delay =< 6 months prior to registration
* Clinically significant pericardial disease (including pericardial effusion, pericarditis) or cardiac valvular disease =< 12 months prior to registration
* NOTE: As part of history and physical, all patients must be assessed for signs or symptoms of cardiac disease, or for prior history of cardiac disease; these conditions include but are not limited to diseases related to cardiac valves, pericardium, myocardium, atrioventricular delays or arrhythmias; it is strongly recommended that signs or symptoms of potentially clinically significant disease be evaluated with comprehensive cardiac echo
* Prior pancreatitis that was symptomatic or required medical intervention =< 6 months prior to registration (known toxicity of pembrolizumab)
* Prior enteritis that was symptomatic or required medical intervention =< 6 months prior to registration (known toxicity of pembrolizumab)
* Uncontrolled hyper/hypothyroidism or hyper/hypocorticism =< 6 months prior to registration (known toxicity of pembrolizumab)
* Pulmonary conditions - any of the following:
* Respiratory condition that required any oxygen supplementation =< 6 months prior to registration
* Prior or current pneumonitis
* Clinically significant pulmonary hypertension =< 12 months prior to registration
* Lung infection requiring treatment =< 3 months prior to registration
* Pulmonary embolism requiring treatment =< 6 months prior to registration
* Pleural effusion requiring drainage =< 12 months prior to registration
* Prior fistula within thorax, including bronchoalveolar or esophageal
* Body mass index (BMI) >= 35 mg/m^2 =< 56 days prior to registration
* Pre-existing motor or sensory neurotoxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1
* Acute bacterial, viral, or fungal infection requiring treatment at the time of registration
* Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
* Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations, or other co-morbid systemic illnesses or severe concurrent diseases which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Prior malignancy =< 5 years prior to registration (except non-melanotic skin cancer or carcinoma-in-situ of the cervix) (must be disease free for a minimum of 5 years); if there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for cancer
* Dementia or altered mental status that would prohibit the understanding and giving of informed consent
* Any of the following because this study involves an agent where the genotoxic, mutagenic and teratogenic effects are unknown:
* Pregnant or breastfeeding
* Patient of childbearing potential who is unwilling to employ adequate contraception
* Received live vaccine =< 30 days prior to registration
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NCT_ID
NCT02730546
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Study_NamePembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery
| 11,057 |
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