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Study Objectives
This is a single site phase I dose escalation trial of the epidermal growth factor receptor inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer (NSCLC). The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle. If there are no Dose Limiting Toxicities (DLTs), dose escalation continues. The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability.
Conditions: Non-Small-Cell Lung Carcinoma
Intervention / Treatment:
DRUG: Erlotinib in combination with Dasatinib
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 or cytologically documented diagnosis of NSCLC that is advanced/metastatic (Stage IIIB/IV).
* Written informed consent.
* The presence of progressive and measurable disease as defined by the -Response Evaluation Criteria in Solid Tumors (RECIST)
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
* Have discontinued all previous systemic therapies for cancer, for at least 14 days prior to study entry and have had previous first line chemotherapy, have recovered from all acute effects of the therapies, and are considered for further chemotherapy, radiotherapy, or other investigational therapy after they have relapsed or progressed on previous treatment.
* Exhibit patient compliance and geographic proximity that allow for adequate follow-up.
* Adequate bone marrow reserve and organ function as follows:
* Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L.
* Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN)
* Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement
* Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
* Reproductive potential must be either terminated (by surgery, radiation, or menopause) or attenuated by the use of an approved contraceptive method during and for 3 to 6 months following the study.
* At least 18 years.
* Agrees to discontinue St. Johns Wort while receiving dasatinib therapy
* Agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
Exclusion Criteria:
* Prior treatment with EGFR tyrosine kinase inhibitors or EGFR targeting agent
* Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Have previously completed or withdrawn from this study or any other study investigating Dasatinib.
* Pregnant or breastfeeding.
* Documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
* Serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
* Uncorrected electrolyte disorder, including potassium <3.0 mEq/L).
* Gastrointestinal disorder that in the opinion of the study physician may affect absorption of either erlotinib or dasatinib. This also includes the inability to swallow tablets.
* Prior major surgery or radiation therapy within 14 days of initiation of treatment
* Electrocardiogram (ECG) abnormalities indicative of cardiac disease (at the discretion of the investigator).
* Uncontrolled angina, congestive heart failure or MI within six (6) months
* Diagnosed or suspected congenital long QT syndrome
* History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
* Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
* Uncontrolled hypertension.
* History of significant bleeding disorder unrelated to cancer, including:
* Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
* Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
* Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
* quinidine,
* procainamide,
* disopyramide,
* amiodarone,
* sotalol,
* ibutilide,
* dofetilide erythromycins,
* clarithromycin,
* chlorpromazine,
* haloperidol,
* mesoridazine,
* thioridazine,
* pimozide,
* cisapride,
* bepridil,
* droperidol,
* methadone,
* arsenic,
* chloroquine,
* domperidone,
* halofantrine,
* levomethadyl,
* pentamidine,
* sparfloxacin; and
* lidoflazine.
* Patients with chronic obstructive pulmonary disease or pleural effusions (malignant or benign) requiring chronic oxygen therapy.
|
NCT_ID
NCT00444015
|
Study_NamePhase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC)
| 15,446 |
Study Objectives
Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and could, in some cases, stop its progression. This drug combination has already been tested in adult patients with refractory tumors and seems to give encouraging results with stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when these drugs are administered separately and in a context different from that of refractory tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the maximum dose at which these two molecules may be administered and to assess the safety of this new combination of drugs.
Conditions: Refractory Solid Tumors in Children
Intervention / Treatment:
DRUG: Combined administration of irinotecan and rapamycin
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age >= 1 year old and =< 21 years;
* Refractory solid tumors, histologically proven at diagnosis (no additional biopsy needs to be performed for the purpose of the study);
* Relapsed or refractory solid tumors after standard treatment or phase II, III-IV clinical trials treatment have failed;
* Karnofsky or Lansky status >= 70%;
* Life expectancy >= 8 weeks;
* No chemotherapy / radiotherapy within 4 weeks before entry into the study;
* Adequate biological parameters :
* Absolute neutrophil count >= 1.0 x 109/L;
* Platelet count >= 100 x 109/L;
* Hemoglobin >= 8 mg/dL;
* Total bilirubine =< 1.5 ULN;
* Transaminases =< 2.5 ULN (=< 5 ULN in case of liver metastases);
* Creatinine clearance (Cockroft) >= 70 mL/min/1.73 m2;
* Normal coagulation profile with prothrombin >= 70%, TCA =< 35 and fibrinogen >= 2 g/L;
* Patients with 1 to 3 previous therapeutic lines are eligible;
* No current grade >= 2 organ toxicity based on NCI-CTCAE version 3.0;
* All patients with reproductive potential must have an effective method of birth control while on study;
* Negative pregnancy test in females when indicated;
* Informed written consent signed by patients or their parents or legal guardians;
* Patient who was informed of the results of prior medical consultation;
* Patient having a social insurance.
Exclusion Criteria:
* Patient with a constitutional anomaly of coagulation and/or of hemostasis (type hemophilia, von Willebrand disease, congenital clotting factor deficit, platelet disorder), exposing them to increased risk of bleeding;
* Pre-treatment with a mTOR inhibitor;
* Other simultaneous malignancy;
* Concurrent administration of any other anti-tumour therapy;
* Known hypersensitivity or contraindication to study drugs or ingredients;
* Severe concomitant disease (e.g. infection disease);
* Patient unable for medical follow-up;
* Pregnancy and/or lactation;
* Patient included in another clinical drug trial;
* Patient taking drugs interfering with pharmacology of rapamycin and/or irinotecan (e.g. drugs interfering with CYP3A4);
* Patient under judicial protection.
|
NCT_ID
NCT01282697
|
Study_NameClinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
| 20,493 |
Study Objectives
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.
Conditions: Liver Cancer
Intervention / Treatment:
DRUG: bevacizumab [Avastin], DRUG: capecitabine [Xeloda]
Location: Singapore, Taiwan, Australia, Hong Kong
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* adult patients >=18 years;
* advanced or metastatic liver cancer;
* >=1 measurable lesion.
Exclusion Criteria:
* current radiotherapy, chemotherapy, or other experimental therapies;
* prior cytotoxic chemotherapy;
* major surgery, open biopsy, or traumatic injury within 28 days of study entry;
* history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.
|
NCT_ID
NCT02013830
|
Study_NameA Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
| 485 |
Study Objectives
This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors.
Conditions: Hepatocellular Carcinoma, Metastatic Castration Resistant Prostate Cancer, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Squamous Cell Carcinoma of Head and Neck, Triple-Negative Breast Cancer, Urothelial Carcinoma, Cholangiocarcinoma, GastroEsophageal Cancer, Pancreatic Cancer, Sarcoma
Intervention / Treatment:
DRUG: Part 1 TPST-1120, DRUG: Part 2 TPST-1120 + nivolumab, DRUG: Part 3 TPST-1120, DRUG: Part 4 TPST-1120 + nivolumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria
* Eastern Cooperative Oncology Group performance status of 0 <= age <= 1 at enrollment
* Progressive disease or previously untreated tumors for which no standard therapy exists or treatment naïve at the time of study entry are eligible
* Have at least one measurable lesion according to RECIST v1.1
* Subjects with the following histologies are eligible and who are refractory to, have failed, are intolerant to, are ineligible for standard therapy, or for which no standard therapy exists are eligible: Part 1 (Dose Escalation- Monotherapy): RCC, NSCLC, CRC, metastatic castration resistant prostate cancer (mCRPC), cholangiocarcinoma, TNBC, pancreatic cancer, HCC, gastroesophageal cancer, squamous cell carcinoma of head and neck (SCCHN), urothelial bladder cancer (UBC), and sarcoma (liposarcomas and leiomyosarcomas); Part 2 (Dose Escalation-Combination with nivolumab): RCC, HCC, and cholangiocarcinoma; Part 3 (Dose Expansion-Monotherapy): RCC, HCC and cholangiocarcinoma; Part 4 (Dose Expansion-Combination with nivolumab): HCC.
Exclusion Criteria
* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a specimen-collection study or the follow-up period of an interventional study
* Any chemotherapy, monoclonal antibody therapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment within 28 days of commencing TPST-1120 treatment. Targeted therapy such as tyrosine kinase inhibitors within 14 days of commencing first dose of study drug(s)
* For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy:
1. Subjects must not have experienced an irAE toxicity that led to permanent discontinuation of prior immunotherapy.
2. Any unresolved irAE > Grade 1 with prior immunotherapy treatment.
* Symptomatic, untreated or actively progressing central nervous system metastases
* Have received fibrates within 28 days before first dose of investigational agent
|
NCT_ID
NCT03829436
|
Study_NameTPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers
| 8,468 |
Study Objectives
This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments using positron emission tomography (PET) imaging in 21 patients with Stage IIIB/IV or recurrent non-small cell lung cancer (NSCLC) and an early post therapy assessment at baseline and at various early time points (2 weeks in 7 patients, 4 weeks in 7 patients, and 6 weeks in 7 patients) after institution of erlotinib (anti-EGFR) (Tarceva) and bevacizumab (anti-VEGF) (Avastin) for first-line treatment of Stage IIIB/IV or recurrent non-squamous NSCLC. The proposed PET imaging and blood derived biomarkers trial is a companion study to an approved therapeutic trial (IRB# 24377). The therapeutic trial of erlotinib (Tarceva) and bevacizumab (Avastin) for first-line treatment of Stage IIIB/IV or recurrent lung cancer with drug costs exceeding $150,000 per patient/year (study drug budget exceeds $5 million) was funded for study at the HCI and the HICCP, statewide trial network. The proposed imaging study has been funded by the University of Utah Synergy Grant Program. The clinical imaging biomarkers will include an assessment of tumor metabolism \[Banrasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber\] (dynamic FDG-PET); tumor proliferation \[Rasey 2002,Shields 2001,Shields 1998, Vesselle 2002, Schwartz 2003\] (dynamic FLT-PET); tumor blood flow and perfusion( H215O-PET)\[Lodge 2000\]; and tumor blood volume of distribution ( H215O -PET)\[Lodge 2000\] in the same patient at baseline and then in the same patient at one of the post therapy time points (2 weeks, 4 weeks, or 6 weeks). The investigators hypothesize that by using a set of imaging derived biomarkers and biomarkers from blood they can predict response, either prior to or at an earlier time point than would normally be determined with standard imaging techniques, in patients with lung cancer receiving combined bevacizumab and erlotinib.
Conditions: Cancer, Non Small Cell Lung Cancer
Intervention / Treatment:
RADIATION: PET Imaging, DRUG: Erlotinib, DRUG: Bevacizumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* All subjects must be enrolled in the the therapeutic trial (IRB # 24377) with non-squamous non-small cell lung cancer (NSCLC) treated with combined erlotinib (Tarceva) (150 mg/day)and bevacizumab (Avastin) (15mg/kg q 21 days) as first line therapy.
* Adults must have radiological evidence of Stage IIIB/IV or recurrent non-squamous non-small cell carcinoma. The Stage IIIB/IV or Recurrent lesion must be in a location that includes a large arterial vessel to allow for determination of the H215O arterial input function. A previous histological diagnosis of NSCLC would be required prior to institution of therapy. Only clinically indicated biopsy and/or surgery for determination of Stage IIIB/IV or recurrent disease will be done and surgery is incidental to inclusion in the protocol.
* Patients must be >= 18 years for inclusion in this study. Since there is no experience with [F-18]FLT in children and it would be inappropriate to study individuals under the age of 18 until more safety data is available.
* After entry into the study, patients are expected to be followed for at least 2 months as part of standard of care.
* All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
* The patient, if female, must be postmenopausal for a minimum of one year or surgically sterile, or on one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera or Norplant. These criteria can be waived at the discretion of the investigator if the patient's tumor is considered life threatening and the one month wait required is not in the best interest of the patient. Negative pregnancy test is accepted.
* Pre-treatment laboratory tests for patients receiving [F-18]FLT must be performed within 21 days prior to study entry. These must be less than 4 times below or above the upper or lower limit range for the respective laboratory test. The patients have Stage IIIB/IV or recurrent NSCLC and therefore many routine laboratory tests may not be within the typical normal range. Using a factor of 4 times above or below the upper or lower value for the normal range for laboratory test will assure ability to recruit patients and maintain safety. In those instances where a value of 4X above the normal range would be inappropriate for inclusion (prothrombin time and partial thromboplastin time) then a value of 2.5X will be used for these two laboratory tests. In those instances when the prothrombin time or partial thromboplastin time are greater than 2.5X the upper limit of normal then such a patient would not be enrolled. The 4X value will be used for all laboratory values except prothrombin time and partial thromboplastin time which cannot be above or below 2.5 times the upper or lower limit of normal (Appendix E, [F-18]FLT Laboratory Study Results). A negative serum pregnancy test is required within 2 days prior to the PET studies.
* Pre-treatment radiological clinical scans/studies (Gd- enhanced MRI or CT to document Stage IIIB/IV or recurrent NSCLC) must be performed within 30 days of study entry.
Exclusion Criteria:
* Patients will be receiving erlotinib (Tarceva) (150 mg/day)and bevacizumab (Avastin) (15mg/kg q 21 days) as part of the therapeutic trial. Enrollment may not occur if the patient does not meet the enrollment criteria for the therapeutic trial
* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
* Patients who are pregnant or lactating or who suspect they might be pregnant.
* Adult patients who require monitored anesthesia for PET scanning.
* HIV positive patients due to the previous toxicity noted with FLT.
* Claustrophobia or inability to remain stationary within the PET scanner for 90 minutes.
|
NCT_ID
NCT00708448
|
Study_NameEarly Prediction of Therapeutic Response to Targeted Therapy in Stage IIIB/IV or Recurrent Lung Cancer Patients
| 967 |
Study Objectives
Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating patients who have advanced colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Conditions: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer
Intervention / Treatment:
DRUG: irinotecan hydrochloride, DRUG: semaxanib, OTHER: laboratory biomarker analysis
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:
* Patients must have histologically confirmed adenocarcinoma of the colon or rectum
* Patients must have locally advanced or metastatic disease not amendable to potentially curative treatment
* Patients must have an ECOG performance status of 0 <= age <= 2
* Men and women of any racial and ethnic group
* Absolute neutrophil count (neutrophils + bands) of >= 1,500/ul
* Platelet count of >= 100,000/ul
* Patients must have a serum creatinine of =< 1.5 mg/dL or a calculated creatinine clearance >= 60 mL/min
* Serum bilirubin =< 1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor
* SGOT must be =< 3 times institutional upper limit of normal
* Patients must be fully recovered from any previous surgery (at least 4 weeks from major surgery)
* Patients must have recovered from prior radiation therapy (at least 4 weeks from radiation)
* Fertile patients (male and female) must agree to use a medically effective contraceptive method throughout the treatment period and for 3 months following cessation of treatment
* Patients must provide written informed consent
* Patients must have either measurable or evaluable disease; measurable disease is defined as at least one bidimensionally measurable lesion >= 1 x 1 cm that is outside the field of any prior radiation therapy
* In Phase I: Patients with a history of a prior malignancy are eligible for treatment
* In Phase II: Patients who have undergone potentially curative therapy for a prior malignancy and who have had no evidence of that disease for > 5 years are eligible for treatment; adequately treated basal cell or squamous cell skin cancer does not apply
* In the Phase I portion of the study the following eligibility criteria must be met:
* Patients must have received no more than two prior chemotherapy regimens (one of which must have contained a fluorinated pyrimidine) for locally advanced or metastatic disease; if a patient progressed while on or within 6 months of adjuvant therapy, the adjuvant regimen will be considered as treatment for metastatic disease
* In the Phase II portion of the study the following eligibility criteria must be met:
* Patients must have received one and only one prior chemotherapy regimen, which must have contained a fluorinated pyrimidine, for treatment of locally advanced or metastatic disease; if a patient progressed while on or within 6 months of adjuvant therapy, the adjuvant regimen will be considered as treatment for metastatic disease
Exclusion Criteria:
* Patients who have previously received SU5416, CPT-11, or any topoisomerase I inhibitor
* Patients with uncompensated coronary artery disease on electrocardiogram or physical examination, or with a history of myocardial infarction, or severe/unstable angina in the past 6 months are not eligible
* Patients with diabetes mellitus with severe peripheral vascular disease and patients who have had a deep venous or arterial thrombosis (including pulmonary embolism) within 3 months of entry are not eligible
* Patients with known allergy to Cremaphor, or Cremophor-based drug products
* Patients with any active or uncontrolled infection
* Patients with psychiatric disorders that would interfere with consent or follow-up
* CPT-11 is known to have teratogenic potential and may be excreted in milk; the current SU5416 Investigator's Brocure indicates that teratogenicity studies have not yet been performed; however, other antiangiogenesis drugs, such as thalidomide, are known to have teratogenic potential; based on the available data, there is potential for significant risk to a developing fetus or breast-feeding child; therefore, pregnant women, women who are breast-feeding, and fertile men and women, unless utilizing birth control are excluded from this study; a negative pregnancy test must be documented during the screening period for women of childbearing potential
* Patients with either a prior history of or clinically apparent central nervous system metastases or leptomeningeal carcinomatosis disease
* Patients with a history of seizures or who are receiving phenytoin, phenobarbital, or other antipileptic prophylaxis
* Patients with uncontrolled diabetes mellitus
* Patients with known Gilbert's Disease (may have excessive CPT-11-induced toxicity)
* Patients with any other severe concurrent disease which in the judgement of the investigator would make the patient inappropriate for the study
* Patients who have received any investigational drug =< 30 days prior to enrollment
|
NCT_ID
NCT00005818
|
Study_NameSU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
| 7,760 |
Study Objectives
This phase I trial studies the side effects and best dose of autologous T-antigen-presenting cells (T-APC) vaccine following therapeutic autologous lymphocytes (CTL) and cyclophosphamide in treating patients with metastatic melanoma. Aldesleukin may stimulate lymphocytes, such as CTL, to kill melanoma cells. Treating lymphocytes with aldesleukin in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Vaccines made from melanoma antigen may help the body build an effective immune response to kill tumor cells and may boost the effect of the CTL. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving T-APC vaccine after CTL and cyclophosphamide may be an effective treatment for melanoma
Conditions: Recurrent Melanoma, Stage IV Melanoma
Intervention / Treatment:
DRUG: cyclophosphamide, BIOLOGICAL: aldesleukin, BIOLOGICAL: autologous tumor cell vaccine, OTHER: laboratory biomarker analysis, OTHER: immunologic technique, OTHER: immunohistochemistry staining method, GENETIC: polymerase chain reaction, BIOLOGICAL: therapeutic autologous lymphocytes
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:
* Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease
* Tumor expression of melanocyte differentiation antigen (MDA: MART-1 = 2+ staining or > 25%) by immunohistochemistry (IHC)
* Expression of human leukocyte antigen (HLA)-A201
* Zubrod performance status of '0 <= age <= 1' at the time of treatment
* Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography [CT] scan)
* Normal cardiac stress test will be required for all patients with any history of cardiac disease
Exclusion Criteria:
* Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry
* Serum creatinine > 1.6 mg/dL or Creatinine clearance < 75 ml/min
* Serum glutamic oxaloacetic transaminase (SGOT) > 150 IU or > 3x upper limit of normal
* Bilirubin > 1.6 mg/dL
* Prothrombin time > 1.5 x control
* Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) < 2.0 L or carbon monoxide diffusing capacity (DLco) (corr for hemoglobin [Hgb]) < 75% will be excluded
* Congestive heart failure
* Clinically significant hypotension
* Symptoms of coronary artery disease
* Presence of cardiac arrhythmias on electrocardiograph (EKG) requiring drug therapy
* Ejection fraction < 50 % (echocardiogram or multi gated acquisition scan [MUGA])
* Symptomatic central nervous system metastases greater than 1 cm at time of therapy; patients with 1 <= age <= 2 asymptomatic, less than 1 cm brain/central nervous system (CNS) metastases without significant edema may be considered for treatment
* Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy
* Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 3 weeks prior to T cell therapy; (patients with bulky disease may undergo cytoreductive chemotherapy but treatment will be discontinued at least 3 weeks prior to T cell therapy)
* Clinically significant autoimmune disorders or conditions of immunosuppression; patients with acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)-1 associated complex or known to HIV antibody seropositive or known to be recently polymerase chain reaction (PCR)+ for hepatitis are not eligible for this study; virology testing will be done within 6 months of T cell infusion; the severely depressed immune system found in these infected patients and the possibility of premature death would compromise study objectives
* Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 3 weeks prior to T cell therapy
* Current treatment with steroids
* Patients must not be receiving any other experimental drugs within 3 weeks of the initiation of the protocol and must have recovered from all side effects of such therapy
* Patients for whom we are unable to generate MART-1 specific T cells
|
NCT_ID
NCT01339663
|
Study_NameVaccine Therapy Following Therapeutic Autologous Lymphocytes and Cyclophosphamide in Treating Patients With Metastatic Melanoma
| 7,093 |
Study Objectives
This pilot clinical trial studies brentuximab vedotin in treating patients with advanced systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab vedotin, 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
Conditions: Aggressive Systemic Mastocytosis, Mast Cell Leukemia, Systemic Mastocytosis
Intervention / Treatment:
DRUG: Brentuximab vedotin
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:
* Written informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 3
* Life expectancy > 12 weeks
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN), if caused by ASM/MCL =< 5 x ULN
* Serum direct bilirubin =< 1.5 x ULN; if considered related to ASM/MCL =< 3 x ULN
* Serum creatinine =< 2.0 mg/dL
* A diagnosis of systemic mastocytosis (SM) per 2008 World Health Organization (WHO) Criteria
* Neoplastic mast cells must express CD30 by immunohistochemistry or flow cytometry
* At least one of the eligible organ damage findings as defined by the international consensus response criteria
* Females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
* Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test result within 7 days prior to the first dose of SGN-35
* Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Exclusion Criteria:
* Unwilling or unable to comply with the protocol
* Any other concurrent severe known disease (except carcinoma in-situ) or concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, or active uncontrolled infection) which could compromise participation in the study
* History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear)
* Cardiovascular disease including congestive heart failure grade III or IV according to the New York Heart Association (NYHA) classification, left ventricular ejection fraction of < 50%, myocardial infarction within previous 6 months or poorly controlled hypertension
* Pregnant or lactating
* Neuropathy greater than or equal to grade 2
* Known hypersensitivity to any excipient contained in the drug formulation
* Confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis
* Presenting with an AHNMD requiring immediate cytoreductive therapy or targeted drugs (eg, AML)
* Received any investigational agent, chemotherapy, interferon-alfa, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to Day 1
* Received hematopoietic growth factor support within 14 days of Day 1 of SGN-35
* Use of prednisone (or equivalent corticosteroid dose) for SM up to 10 mg/day or its equivalent is allowed, but it cannot have been started during screening; patients who are on prednisone up to 10 mg/day for medical problems unrelated to SM are also permitted on study
* Presence of FIP1L1-PDGFR-alpha fusion even with resistance to imatinib
* Received any treatment with SGN-35 prior to study entry
* Any surgical procedure within 14 days of Day 1, excluding central venous catheter placement or other minor procedures (eg, skin biopsy)
|
NCT_ID
NCT01807598
|
Study_NameBrentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia
| 21,808 |
Study Objectives
This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC).
The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
DRUG: AG-013736
Location: Taiwan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically diagnosed HCC, OR clinically diagnosed HCC
* Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional therapy
* Documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced HCC
* At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure
* ECOG performance status 0 or 1
* Life expectancy is at least 2 months
* Child-Pugh class A liver function.
Exclusion Criteria:
* Systemic therapy other than sorafenib as first-line therapy for advanced HCC
* History of HCC tumor rupture
* Presence of brain or leptomeningeal metastases
* Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding
* History of upper gastrointestinal bleeding within 1 year
* Major systemic diseases that the investigator considers inappropriate for participation
* Uncontrollable hypertension
* Proteinuria
* Current use or anticipated need for treatment with potent CYP3A4 inhibitor, CYP3A4 or CYP1A2 inducers
* Requirement of anticoagulant therapy with oral vitamin K antagonists
* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study
|
NCT_ID
NCT01273662
|
Study_NameAxitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
| 1,365 |
Study Objectives
This study will assess the impact of CYP450 2D6 genotype pharmacogenetic testing and the corresponding prescribing impact for postmenopausal women using tamoxifen in a patient care setting for prevention of recurrent breast cancer.
Conditions: Breast Neoplasms, Tamoxifen
Intervention / Treatment:
OTHER: Poor Metabolism Status Follow Up Therapy Considerations, OTHER: CYP2D6 Inhibiting Drugs
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Patient currently has a pharmacy benefit with Medco for an enrolled client
* Patient has a adjudicated tamoxifen pharmacy claims within the last six months
* Patient is still taking tamoxifen to prevent recurrent breast cancer
* Patient is a natural postmenopausal women 50 years or older
* Patient signs consent
* Patient is willing to provide sample for genetic testing
* Physician managing tamoxifen therapy is willing to order pharmacogenetic test
Exclusion Criteria:
* Patient is male
* Patient is under 50 years
* Patient has previous history of CYP450 2D6 testing
* Patient is no longer taking tamoxifen
* Patient refuses to sign consent
* Patient wishes to no longer participate after testing
* Patient's physician refuses to order pharmacogenetic test
|
NCT_ID
NCT00830973
|
Study_NameThe Clinical and Economic Impact of Pharmacogenomic Testing for Tamoxifen Metabolism in Postmenopausal Women Receiving Tamoxifen for Prevention of Recurrent Breast Cancer
| 1,947 |
Study Objectives
The purpose of this study is to determine if a medication called mannitol, can help the kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in urine production (it is a diuretic). For many years, mannitol has been given to patients in the hope it would improve the kidney's circulation, and in doing so reduce the impact of the surgery on the kidney.
Mannitol is given during the surgery before the blood supply to the kidney is stopped. The blood supply to the kidney is stopped in order to minimize any blood loss during the removal of the tumor, and also to assist the surgeons view of the kidney anatomy. Once the tumor is removed the blood supply to the kidney is resumed. Sometimes a side effect of this temporary reduction in blood supply to the kidney is the loss of some kidney function. This may happen either in the short term (right away) or long term (months or years later). In studies done on animals, mannitol was able to lessen this damage to kidney function. However, no human study has ever confirmed that mannitol has the same helpful effect in humans. There is some suggestion that it may have no effect. Because sufficient research has yet to be done on humans, many surgeons do not give mannitol. A recent study, conducted at Memorial Sloan Kettering which looked back at patients who had undergone partial nephrectomies, an operation where only the portion of the kidney that contains the tumor is removed and enables the normal, unaffected portion of the kidney to be preserved. The results of this study demonstrated no significant difference in kidney function when the investigators compared patients who were given mannitol to those who were not. The investigators hope that this study will help clarify the effectiveness or not of mannitol on kidney function. During the surgery to remove the kidney tumor, patients will receive either mannitol or a placebo. A placebo, is a harmless medication that has no effects. The impact of mannitol compared to the placebo will be assessed by routine blood tests and imaging (kidney scan) 6 months after your surgery.
Conditions: Renal Cancer
Intervention / Treatment:
DRUG: mannitol, OTHER: placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Age > or = to 18 years
* Scheduled for partial nephrectomy at MSKCC (open or minimally invasive technique) during which renal ischemia is anticipated
* Preoperative eGFR > 45 cc/min/1.73m2 as measured by the CKD-EPI study equation
Exclusion Criteria:
* Allergy to mannitol
* Severe renal impairment (stage 3B) defined as eGFR < 45 cc/min/1.73m2 as measured by the CKD-EPI calculation.
* Combined major surgical cases that include a partial nephrectomy.
|
NCT_ID
NCT01606787
|
Study_NameMannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes
| 20,393 |
Study Objectives
The primary objective is to evaluate the effect of omeprazole on the pharmacokinetics of famitinib malate in healthy adult subjects.
The secondary objective is to evaluate the safety after famitinib malate alone or combined administration with omeprazole in healthy adult subjects.
Conditions: Tumor
Intervention / Treatment:
DRUG: famitinib、omeprazole
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Participants should sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study;
* Capable to complete the study according to the requirements of study protocol;
* Healthy male and female subjects aged between 18 and 45 (inclusive) at the time of signing the informed consent, of which no less than 1/3 are female subjects;
* Participants should have no fertility plan from signing the informed consent until 6 months after the last medication, take effective contraceptive measures voluntarily and have no sperm donation plan. The serum HCG test of fertile women must be negative before Screening;
* Body weight >= 50.0 kg for men and body weight >= 45.0 kg for women, and body mass index (BMI) within the range of 19.0 to 28.0 kg /m2 (inclusive);
* Creatinine clearance (CLCr) >=80 mL/min, and creatinine is less than or equal to the upper limit of normal value.
Exclusion Criteria:
* Those who donated blood or suffered blood loss >=400 mL within 3 months prior to Screening, donated blood or suffered blood loss >=200 mL within 1 month prior to Screening, or received blood transfusion;
* Allergic constitution, including a history of severe drug/food allergy; Any history of allergy to famitinib malate capsules or omeprazole magnesium enteric-coated tablets;
* Any history of drug abuse, positive results for alcohol, nicotine or drugs at Screening;
* Those who have heavy smokers and alcoholic will not be able to prohibit smoking and alcohol during the trial;
* Any history of dysphagia or any gastrointestinal disease that affects drug absorption;
* Those who have any uncontrolled peptic ulcer, colitis, pancreatitis, etc.;
* Those who have received any operation within 6 months before Screening; Previous surgery affecting gastrointestinal absorption (including gastrectomy, intestinal resection, gastric contraction surgery, etc.);
* Subjects with any clinically significant acute disease occurring within 1 month prior to Screening;
* QTcF>470 msec for women or >450 msec for men;
* Any pre-existing chronic or severe medical history of nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism, and musculoskeletal system;
* Participation in any clinical trial within 3 months before Screening;
* Those who took any other drugs that affect liver metabolism within 28 days prior to taking the investigational drug;
* Those who took any prescription or non-prescription drugs, any vitamin products or herbal medicine within 14 days prior to receiving the investigational drug;
* Abnormal vital signs at Screening;
* Clinical laboratory tests, infectious disease screening, 12-lead electrocardiogram, abdominal B ultrasound, X-ray or CT examination with abnormalities and clinical significance;
* Consumption of grapefruit or grapefruit products, caffeine, or xanthine foods or beverages within 48 hours prior to taking the investigational drug; Strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
* Lactating women;
* History of injection needle or blood fainting, those who have difficulty in blood collection or cannot tolerate venepuncture blood collection; Those who cannot accept a uniform diet;
* Subjects with other factors unsuitable to participate in the study considered by the researcher or subjects withdraw from the study due to their own reasons.
|
NCT_ID
NCT05041920
|
Study_NameA Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects
| 2,225 |
Study Objectives
The purpose of this proposal is to improve our understanding of the role of tryptophan and serotonin in hot flashes. The main hypothesis is that alterations in tryptophan and serotonin levels are involved in the induction of hot flashes in women with breast cancer and genetic variations in the serotonin receptors and transporters also play a role.
Conditions: Breast Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Acute tryptophan depletion, DIETARY_SUPPLEMENT: Half-strength tryptophan depletion (Control)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: BASIC_SCIENCE
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: DOUBLE
|
Inclusion Criteria:
* At least 18 years
* Willing and able to provide informed consent
* Reporting daily hot flashes
* Able to read, write, and speak English
* Postmenopausal to limit sample variability (> 12 months amenorrhea)
* Greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.
* These criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. Menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.
Exclusion Criteria:
* Exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances.
|
NCT_ID
NCT00228943
|
Study_NameThe Role of Serotonin in Hot Flashes After Breast Cancer
| 17,185 |
Study Objectives
The purpose of this study is to determine how effective and safe a new investigational drug is in treating patients with relapsed or refractory multiple myeloma. The treatment involves daily dosing. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
Conditions: Carcinoma, Renal Cell
Intervention / Treatment:
DRUG: GW786034
Location: United States, Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion criteria:
* Must have diagnosis of relapsed or refractory multiple.
* bone marrow function [ANC (absolute neutrophil count) greater than 1000/mm3]; platelet count greater than or equal to 75,000/mm3.
* renal function (calculated creatinine clearance >50 mL.min, albumin less than or equal to 500 mg).
Exclusion criteria:
* Failed more than 3 prior lines of therapy including stem cell transplant.
* Females who are pregnant or nursing.
* Unstable blood pressure.
* Significant heart conditions or history of thrombosis.
* Any unstable, pre-existing major medical condition or history of other cancers.
* Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.
|
NCT_ID
NCT00256880
|
Study_NamePazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma
| 5,391 |
Study Objectives
Time to progression (physical examination and radiologic imaging
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: Paclitaxel
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* patients with primary ovarian cancer
* ECOG- 0 <= age <= 2
* Age >= 18
* no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer
* adequate bone marrow, liver and kidney reserve: leukocytes >= 2.0 x 109/l, platelets >= 100 x 109/l, bilirubin <= 2,0 mg%, creatinine <= 1,5 mg% or creatinine clearance >= 60 ml/ min, hemoglobin >= 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range
* written informed consent
Exclusion Criteria:
* before-existing heart illness, Cardiac infarct within last 6 months
* Radiotherapy within 4 weeks for study entry
* Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)
|
NCT_ID
NCT00158379
|
Study_NameTaxol Carboplatin and Erythropoetin
| 8,999 |
Study Objectives
The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Sutent
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:
* Has measurable, metastatic NSCLC, other elderly NSCLC patients > 70 years who are not felt to be candidates for standard chemotherapy at the discretion of the treating physician may also be enrolled as long as they meet the criteria; these "special consideration" patients enrollment in the study must be approved by Dr. Reynolds or DR. Smith in Dr. Reynolds absence. Patients must have a nonsquamous histology to be eligible for this study.
* Has not received any prior chemotherapy for the current disease.
* Has an ECOG Performance status. Is 70 years or older.Has resolution of all acute toxic effects of radiotherapy or surgical procedures to NCI CTCAE.
* If fertile, patient (males only) has agreed to an acceptable method of birthcontrol to avoid pregnancy for the duration of the study and for a period of 2 months thereafter.
* Has signed the most recent Patient Informed Consent Form. Has signed a Pate int Authorization Form.
Exclusion Criteria:
* Has predominantly squamous NSCLC histology.
* Had prior treatment with study drugs or other drugs.
* Has a history of hypersensitivity to any component of the study drug. Has any evidence of an of antecedent hemoptysis, squamous histology, or ongoing anticoagulation or clotting diathesis.
* Pre-existing hemoptysis Grade 2, cavitating lesions or clear proximity or involvement of blood vessels.
* Has had major surgery or radiation therapy within 4 weeks of starting the study treatment.
* Has had NCI CTCAE (Version 3.0) Grade 3 <= age <= 4 hemorrhage within 4 weeks of starting the study treatment.
* Has a history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan; however, treated, stable, and asymptomatic brain metastases are allowed.
* Has had any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade 2.
* Has prolonged QTc interval on baseline EKG. Has uncontrolled hypertension.
* Has pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
* Is receiving concurrent treatment on another clinical trial.
* Supportive care trials or non-treatment trials, (eg, QOL), are allowed.
* Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy.
* Is receiving concurrent investigational therapy or has received such therapy within the past 30 days.
* Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
* Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.
* Is unable to comply with requirements of study
|
NCT_ID
NCT00864721
|
Study_NameSunitinib Non Small Cell Lung Cancer Patients Over 70
| 12,591 |
Study Objectives
Phase I trial to study the effectiveness of gefitinib in treating children who have refractory solid tumors. Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth
Conditions: Unspecified Childhood Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: gefitinib, 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
|
Inclusion Criteria:
* Histologically confirmed solid tumor at original diagnosis
* Refractory to conventional therapy and other therapies of higher priority according to the COG Phase I/II priority list or no conventional therapy exists
* No primary CNS tumors or known metastases to the CNS
* Performance status - Karnofsky 50 <= age <= 100% (> 10 years)
* Performance status - Lansky 50 <= age <= 100% (10 years and under)
* At least 8 weeks
* Absolute neutrophil count at least 1,000/mm^3
* Platelet count at least 50,000/mm^3 (transfusion independent)
* Hemoglobin at least 8.0 g/dL (RBC transfusion allowed)
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT no greater than 3 times ULN
* Albumin at least 2 g/dL
* Creatinine normal for age
* Glomerular filtration rate at least 70 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
* At least 6 months since prior allogeneic stem cell transplantation (SCT)
* No evidence of active graft-versus-host disease
* At least 1 week since prior biologic agents
* At least 1 week since prior hematopoietic growth factors
* Recovered from prior immunotherapy
* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
* No concurrent tamoxifen
* At least 2 weeks since prior local palliative (small port) radiotherapy
* At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis (6 weeks for radiotherapy to other substantial amount of bone marrow)
* Recovered from prior radiotherapy
* No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, Amiodarone, or chloroquine)
* No concurrent enzyme-activating anticonvulsants
* No concurrent proton pump inhibitors or H-2 blockers within 4 hours of gefitinib administration
|
NCT_ID
NCT00040781
|
Study_NameGefitinib in Treating Children With Refractory Solid Tumors
| 14,046 |
Study Objectives
The purpose of this study is to evaluate efficacy of gemcitabine and cisplatin combined with either radical cystectomy or radiotherapy in the treatment of bladder cancer.
Conditions: Bladder Cancer
Intervention / Treatment:
DRUG: gemcitabine, DRUG: cisplatin, PROCEDURE: radical cystectomy, PROCEDURE: radiotherapy
Location: Poland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically proven urothelial carcinoma of the urinary bladder in stage T2b-T3, N0/Nx, M0.
* Patients must have measurable disease. Response assessment will be evaluated according to RECIST criteria. Measurable lesions with clearly defined margins will be evaluated by X-Ray, Transvesical Ultrasound, CT-Scan or MRI, cystoscopy.
* Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal 20 mm.
Exclusion Criteria:
* Patients with prior or concomitant malignant diseases (other than appropriately treated basal cell carcinoma of the skin or carcinoma of the cervix)
* PSA greater than 5.0 ng/mL
* Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
|
NCT_ID
NCT00490880
|
Study_NameNeoadjuvant Chemo (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer
| 5,762 |
Study Objectives
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
Conditions: Chemotherapeutic Agent Toxicity, Neuropathy, Neurotoxicity Syndrome, Pain, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer
Intervention / Treatment:
DRUG: Carboplatin, DRUG: Glutathione, OTHER: Laboratory Biomarker Analysis, DRUG: Paclitaxel, OTHER: Placebo, OTHER: Quality-of-Life Assessment
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* Scheduled to undergo treatment with TAXOL at 150 <= age <= 200 mg/m2 and CBDCA at area under the curve (AUC) = 5 <= age <= 7 every 21 or 28 days for at least 12 weeks; alternatively, paclitaxel can be prescribed at 80 mg/m2 weekly for at least 12 weeks, with the same CBDCA dose of AUC = 5 <= age <= 7 every 21 days; additional chemotherapy agents are allowed (bevacizumab, etoposide, etc) per physician discretion, as long as they are not known to be neurotoxic; Note: patients ideally will begin GSH therapy prior to their first dose of this chemotherapy, but must begin GSH therapy prior to their second dose of chemotherapy
* Ability to sign informed consent and understand the nature of a placebo-controlled trial
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* Ability to complete English language questionnaire(s) by themselves or with assistance
* Life expectancy >= 6 months
* Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only, per clinician discretion
* Willingness to provide blood specimens as required by the protocol
* White blood cell (WBC) >= 3400
* Absolute neutrophil count (ANC) >= 1500
* Platelet (PLT) >= 100,000
* Hemoglobin (HgB) > 10.0
* Creatinine =< 1.5 x upper limit of normal (ULN)
Exclusion Criteria:
* Pre-existing history of peripheral neuropathy > grade 1 (National Cancer Institute [NCI] CTCAE version [v] 4.0) due to any cause (e.g., chemotherapy, diabetes, alcohol, toxin, or heredity)
* Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
* Any of the following:
* Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception
* Prior TAXOL and/or CBDCA chemotherapy treatment (other than the current treatment regimen)
* Concurrent use of any agent being used specifically to prevent or treat neuropathy, including but not limited to the following:
* Gabapentin
* Glutamine powder or glutamine tablets
* Vitamin B6 or E
|
NCT_ID
NCT02311907
|
Study_NameGlutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
| 19,149 |
Study Objectives
The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.
Conditions: Anemia, Non-Myeloid Malignancies
Intervention / Treatment:
DRUG: Darbepoetin alfa - 2.25 mcg/kg, DRUG: Darbepoetin alfa - 500mcg
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Non-myeloid malignancy
* At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
* Eastern Cooperative Oncology Group performance status of 0 <= age <= 2
* Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
* Of legal age at the time written informed consent is obtained
Exclusion Criteria:
* Known history of seizure disorder
* Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
* Unstable or uncontrolled disease/condition, related to or affecting cardiac function
* Clinically significant inflammatory disease
* Inadequate renal and/or liver function
* Known positive HIV test
* Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
* Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1
* Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1
* Other investigational procedures
* Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
* Pregnant or breast feeding
* Not using adequate contraceptive precautions
* Known sensitivity to any of the products to be administered during dosing
* Previously randomized in this study
* Concerns for subject's compliance with protocol procedures
|
NCT_ID
NCT00118638
|
Study_NameA Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
| 10,790 |
Study Objectives
The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.
Conditions: Hodgkin Disease, Lymphoma, Large-cell, Anaplastic
Location: Russian Federation
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Male and female participants >= 18 years by the time of enrollment.
* Histologically confirmed diagnosis of cHL or sALCL.
* Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion in the Study.
Exclusion Criteria:
* Unconfirmed diagnosis of cHL or sALCL.
* Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials.
* Participation in the non-interventional study CHL-5001 "An international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical Hodgkin lymphoma (B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG).
* Participants for whom the minimum study dataset was not available from their hospital medical records.
|
NCT_ID
NCT03942263
|
Study_NameA Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation
| 4,545 |
Study Objectives
The purpose of this Phase II study will assess the effectiveness of the combination of oral cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who cannot be cured by surgery, radiation or conventional chemotherapy.
Conditions: Osteosarcoma
Intervention / Treatment:
DRUG: Cyclophosphamide and Sirolimus
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:
* Progressive or recurrent, advanced (unresectable or metastatic) high-grade osteosarcoma, Ewing's or soft tissue sarcoma previously treated with chemotherapy.
* Bi-dimensionally measurable lesion(s) on cross-sectional radiography, such as computed tomography or magnetic resonance imaging, within 2 weeks of enrollment.
* ECOG/Zubrod performance score 0, 1 or 2.
* Total WBC >3,000, neutrophil count >1,000, platelet count >100,000 within 2 weeks of enrollment.
* Serum creatinine <2.0 times the institutional upper limit of normal (IULN) within 2 weeks of enrollment.
* AST and ALT <2.5 times IULN (or if liver involvement by sarcoma <5 times IULN) within 2 weeks of enrollment.
* Able to ingest oral medications.
* Sexually active women and men of childbearing potential must agree to use an effective method of birth control during the course of the study and for up to 1 month following the last dose of the study drug, in a manner such that risk of pregnancy is minimized. Surgical sterilization, oral contraceptive pills, intrauterine device, double barrier (e.g. condom and diaphragm or spermicidal agents) or abstinence are acceptable forms of birth control.
* Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to treatment.
* Patient must be >16 years at the time the consent document is signed by the patient.
* A paraffin block containing sarcoma, either from a previous surgery or recent biopsy, must be available for correlative studies. If a paraffin block containing sarcoma is not available, patients are required to undergo biopsy to obtain tissue for the correlative studies.
Exclusion Criteria:
* Active infection requiring antibiotic treatment.
* Diabetes mellitus not under good control (e.g. hemoglobin A1c > 8% or fasting glucose > 180 mg/dl) with oral agents or insulin.
* Prior treatment with mTOR inhibitor for sarcoma.
* Less than 3 weeks from prior treatment with chemotherapy to start of treatment with cyclophosphamide and sirolimus. Toxicities from prior chemotherapy (except alopecia) should be grade 1 or less before starting treatment with cyclophosphamide and sirolimus.
* Prior radiation less than two weeks since the administration of the last fraction of radiation therapy to the start of treatment. Patients must have recovered from grade 2 or higher radiation-associated toxicities to be eligible. All measurable lesions, which are being targeted, must be outside previously radiated fields or have documented progression at least 6 weeks after completion of radiation.
* Untreated or active CNS involvement by sarcoma.
* Active second malignancy other than carcinoma in situ. Patients with malignancy other than sarcoma in remission are eligible.
* Women who are pregnant or breastfeeding.
|
NCT_ID
NCT00743509
|
Study_NameA Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma
| 18,089 |
Study Objectives
This randomized phase II trial studies how well botulinum toxin type A works in preventing complication after surgery in patients with esophageal cancer. Botulinum toxin type A may cause less complications of nausea and vomiting after surgery.
Conditions: Esophageal Carcinoma
Intervention / Treatment:
BIOLOGICAL: Botulinum Toxin Type A, PROCEDURE: Esophagectomy, OTHER: Quality-of-Life Assessment
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic anastomosis
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Patients who have a history of gastrointestinal dysmotility or functional gastroparesis, including diabetic gastroparesis, central and peripheral nervous system disorders, renal failure, medication side effects, including chronic dependence of promotility agents, anticholinergic antispasmodic agents, or chronic narcotic use > 2 years due to non-cancer causes
* Patients who have a history of previous gastric or duodenal surgery
* Patients who have a history of duodenal ulcer or duodenal fibrosis
* 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
* Allergy to botulinum toxin and/or egg
* Pregnant or nursing female participants
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation
|
NCT_ID
NCT02965976
|
Study_NameBotulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
| 3,204 |
Study Objectives
The purpose of this study is to determine the effectiveness of two drugs, docetaxel and Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone therapy. The investigators are interested in finding out if the combination of these two drugs is more effective than docetaxel alone in the treatment of prostate cancer.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Gleevec, DRUG: Docetaxel
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:
* Must have a histologic diagnosis of adenocarcinoma of the prostate Stage D2 that is unresponsive or refractory to hormone therapy. Must have metastatic prostate cancer with a rising PSA, and deemed to be hormone refractory.
* All subjects must have pre-study PSA within 28 days prior to registration
* Subjects who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to registration. Subjects must have non-measurable disease assessed within 28 days (for PSA level) or 42 days (for imaging studies) prior to registration.
* Subjects with bone metastases, as documented by X-ray, bone scan, MRI, or biopsy.
* All subjects must have had a CT scan of the abdomen and pelvis within 28 days prior to registration.
* Subjects must have been surgically or medically castrated. If the method of castration was LHRH (Luteinizing Hormone-Releasing Hormone) agonists, then the subject must be willing to continue the use of LHRH agonists.
* If the subject has been treated with non-steroidal anti-androgens or other hormonal treatment these agents must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole, and at least 42 days prior to enrollment for bicalutamide or nilutamide; and the subjects must have demonstrated progression of disease since the agents were suspended.
* Prior radiation therapy is allowed. At least 21 days must have elapsed since the completion of radiation therapy, and the subject must have recovered from the side effects of the radiation
* 9. Due to the unknown side effects of imatinib, men of reproductive potential must agree to use an effective contraceptive method.
* Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have significant active concurrent other medical illness precluding protocol treatment.
* ECOG performance status of 0 <= age <= 1
* ANC >= 1,500/mL and a platelet count of ³ 100,000/mL. These tests must be obtained within 7 days prior to registration.
* Serum bilirubin <= 1.3, SGOT and SGPT <= 2 x institutional upper limit of normal, and a serum creatinine <= 1.8 mg/dl. These tests must be obtained within 7 days prior to registration. Testosterone level may be done 28 days prior to study entry. Testosterone level should be below 50 ng/dL.
Exclusion Criteria:
* No prior chemotherapy for hormone-refractory disease is allowed. At least three weeks must have elapsed since the completion of any non-cytotoxic investigational therapy, and the patient must have recovered from the side effects of the therapy.
* No other cytotoxics, biological response modifiers, radiation therapy, corticosteroid or hormonal concomitant therapy (other than continuing LHRH treatment) may be given during protocol treatment. Bisphosphonates may be given during protocol treatment. No unconventional therapy may be given during protocol treatment.
* Subjects must NOT have Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
* Subjects with known chronic liver disease are NOT eligible
* Must NOT have a known diagnosis of human immunodeficiency virus (HIV) infection.
* Subjects must NOT have known brain metastases.
* No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of any site, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
|
NCT_ID
NCT00251225
|
Study_NameA Study of Imatinib and Docetaxel in Prostate Cancer
| 2,549 |
Study Objectives
RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A stem cell transplant may be able to replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan hydrochloride.
PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131 given together with topotecan hydrochloride and to see how well it works in treating young patients with refractory or relapsed metastatic neuroblastoma.
Conditions: Neuroblastoma
Intervention / Treatment:
DRUG: Topotecan hydrochloride, PROCEDURE: Autologous hematopoietic stem cell transplantation, RADIATION: iobenguane I 131, RADIATION: total-body irradiation
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion criteria:
* Histologically confirmed neuroblastoma
* Metastatic disease that is recurrent or refractory to induction therapy
* Primary or metastatic tumor target with MIBG fixation (tumor/soft tissue) > 2
* Autologous bone marrow or peripheral blood stem cells must be available
* WHO performance status (PS) 0 <= age <= 1 OR Lansky PS 70 <= age <= 100%
* Life expectancy > 2 months
* ANC >= 1,000/mm³
* Platelet count >= 100,000/mm³
* Creatinine clearance normal for age
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior hypersensitivity to topotecan or its excipients
* No toxicity to other organs >= NCI-CTCAE v3.0 grade 2
* No other debilitating disease
* No HIV positivity
* More than 30 days since prior external-beam radiation (6 weeks if cranio-spinal, abdominal, or pulmonary)
* At least 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
* No other contraindicated biologic therapy that cannot be discontinued for >= 4 courses during MIBG therapy
Exclusion criteria:
* Pregnancy or breastfeeding women
* HIV positive
* Participation to another phase I,II or III clinical trial
* Other invalidating pathology
* Concomitant treatment interfering with MIBG
* Hypersensibility to Topotecan
|
NCT_ID
NCT00960739
|
Study_NameIodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma
| 4,012 |
Study Objectives
A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.
Conditions: Basal Cell Carcinoma
Intervention / Treatment:
BIOLOGICAL: Imiquimod and Interferon alpha
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Nodular or superficial basal cell carcinoma on the skin excluding scalp or face
Exclusion Criteria:
* Pregnancy
|
NCT_ID
NCT00581425
|
Study_NameIntron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)
| 3,886 |
Study Objectives
This is a single-centre, open label, dose finding, phase I study to determine the recommended phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in patients with advanced tumours and no standard treatment options. A minimum of 3 patients will be enrolled per dose level and intra-patient dose escalation is not permitted. Once the RP2D has been identified, six additional patients with metastatic solid tumours will be treated at the RP2D to confirm its tolerability.
Conditions: Advanced Solid Tumours
Intervention / Treatment:
DRUG: pantoprazole sodium for injection, DRUG: doxorubicin hydrochloride injection
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have histologically or cytologically proven advanced solid tumours for whom no standard anticancer therapy exists
* Measureable and non-measureable disease are both eligible, but disease must be evaluable as defined by RECIST 1.1.
* Patients >18 years
* At least 21 days since last chemotherapy regimen and/or radiotherapy
* Recovery from all reversible adverse events of previous anticancer therapies to baseline or to grade < or =1, except for alopecia.
* Patients must have documented evidence of disease progression on prior systemic therapy.
* ECOG Performance Status of 0 or 1
* Adequate cardiovascular function and no history of serious cardiac diseases (see Exclusion criteria for definition) Left ventricular ejection fraction > 50% by multi-gated nuclear angiogram
* Patient consent must be obtained according to Institutional REB requirements. The patient must sign the consent form prior to registration.
* Patients must be accessible for treatment and follow-up.
* Previous Therapy
1. Chemotherapy: Patients can have had limited exposure to prior anthracyclines defined as no more than a total dose of 240 mg/m2 of doxorubicin or 300 mg/m2 of epirubicin (e.g. as received in the AC x 4 or FEC x 3 adjuvant regimens). Patients with prior exposure to other cardiotoxic anticancer drugs (e.g. mitoxantrone) are not eligible.
2. Radiation: Patients may have had prior radiation therapy (including that to the breast or chest wall) provided that has not exceeded 25% of the bone marrow reserve.
3. Previous Surgery: Previous surgery is permitted provided that wound healing has occurred.
4. Hormonal Therapy: Patients may have had prior hormonal therapy. All hormonal agents must be discontinued at least 3 weeks prior to study entry.
* Laboratory Requirements (must be done within 7 days prior to registration)
1. Neutrophil count (ANC) > or = 1.5 x 10^9/L
2. Hemoglobin > or = 90 g/L
3. Platelet count > or = 100 x 10^9/L
4. Bilirubin <1.5 x UNL
5. AST or ALT < or = 2 x UNL
6. Creatinine < or = 1.5 x UNL or creatinine clearance > or = 50mL/min
Exclusion Criteria:
* Patients who have previously received more than 240 mg/m2 doxorubicin or 300 mg/m2 epirubicin.
* Patients receiving concurrent treatment with experimental drugs or anti-cancer therapy.
* Patients who are receiving drugs that are known to interact with pantoprazole, including:
1. The anti-fungal agents fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;
2. The antiviral agents: atazanavir, delavirdine, indinavir, nelfinavir, raltegravir, saquinavir, tipranavir;
3. The anticoagulant agents: clopidogrel, dabigatran;
4. The immunosuppressive agent: mycophenolate
5. The anti-inflammatory agent: mesalamine
* Patients who are receiving oral pantoprazole or other PPI inhibitors may participate if these agents are discontinued at least 7 days before trial entry.
* Patients with untreated brain or meningeal metastases. (MR or CT scans are not required to rule this out unless there is a clinical suspicion of CNS disease). Patients with treated and stable brain metastases are eligible providing that they have radiological evidence of disease stabilization of at least 3 months duration and are asymptomatic.
* Patients who have a history of clinically significant cardiac disease, including:
1. Unstable angina/ acute coronary syndrome
2. Congestive heart failure
3. Myocardial infarction within the past year
4. Clinically significant arrhythmia
5. Pericarditis or myocarditis
6. Symptomatic valvular disease Patients with well-controlled hypertension, uncomplicated mitral valve prolapsed or other stable cardiac conditions are eligible.
* Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.
* Patients with a known bleeding disorder. Patients who are on stable anticoagulation with warfarin or s.c. heparin products are eligible. Patients receiving clopidogrel are excluded.
* Patients unable or unwilling to give written, informed consent prior to study participation.
* Women who are pregnant or nursing.
|
NCT_ID
NCT01163903
|
Study_NamePantoprazole With Doxorubicin for Advanced Cancer Patients With Extension Cohort of Patients With Solid Tumours
| 16,399 |
Study Objectives
The purpose of this study is to see how well DFD-07 works in treating actinic keratosis on the face and scalp during 8 weeks of treatment. The study will also look at any unwanted effects of the study drug.
Conditions: Actinic Keratosis
Intervention / Treatment:
DRUG: DFD-07 Cream, DRUG: Placebo Cream
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
To be eligible for the study, the patients have to fulfil all of the following criteria at Visit 1:
* Written informed consent has been signed and dated prior to any study related procedure or initiation of a wash out period
* Skin type I, II or III according to Fitzpatrick
* 5 <= age <= 8 Actinic Keratosis (AK) mild to moderate grade lesions in an approximately 25 cm2 region of scalp, forehead or face that are non-hypertrophic and non-hyperkeratotic
* 18 years or older
* Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with a secondary contraceptive option should the patient become sexually active. All women of childbearing potential must have a negative urine pregnancy test (test must have a sensitivity of at least 25 IU/ML for human chorionic gonadotropin) at the Baseline Visit. A female is considered of childbearing potential unless she is pre-menarche, postmenopausal with no menses for at least 12 months or surgically sterile. Reliable methods of contraception are hormonal methods or intrauterine devices in use for at least 90 days prior to the Baseline Visit or barrier methods plus spermicide use for at least 14 days prior to the Baseline Visit or a partner who has had a vasectomy at least 3 months prior to the Baseline Visit.
* >= 60 days washout from prohibited medications:
* Masoprocol
* 5-Fluorouracil
* Cyclosporine
* Retinoids
* Trichloroacetic Acid/Lactic Acid Peel
* 50% Glycolic Acid Peel
* Topical or systemic diclofenac, celecoxib or any other non-sterioda anti-inflammatory drug (however daily low-dose aspirin is allowed, as long as the patient has been on a stable dose, <= 100 mg once a day, for 60 days prior to the start of the study.) Note: Patients may use acetaminophen/paracetamol as needed
* Photodynamic therapy
* Topical or systemic immunomodulating agents including:
* Systemic, topical or intralesional interferon
* Imiquimod (Aldara, Zyclara)
* Topical ingenol mebutate (Picato)
* Topical tacrolimus
* Topical pimecrolimus
* Sirolimus
* Cyclosporin
* Intralesional Bacillus Calmette-Guerin (BCG)
* Topical coal tar products
* Topical or systemic corticosteroids
Exclusion Criteria:
Patients who fulfil one or more of the following criteria, will not be eligible for the study:
* Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drug (NSAID) or a component of the formulation of the study medication
* Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
* Significant history (within the past year) of alcohol or drug abuse
* Participation in any clinical research study within 60 days of the Baseline Visit.
* Pregnancy, lactation or plans to become pregnant
* Concomitant use of cosmetics or other topical drug products on or near the selected treatment area. However, the use of topical sunscreens is allowed.
* Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 2 weeks and within 2 cm of the selected treatment area.
* Other skin conditions within the selected treatment area (e.g. rosacea, psoriasis, atopic dermatitis, eczema, basal or squamous cell carcinoma or albinism)
* Use of sun lamps or tanning beds or booths during the 14 days prior to the Baseline Visit or planned use during the study.
* Any systemic cancer therapy within 6 months of the Baseline Visit
|
NCT_ID
NCT02654717
|
Study_NameEight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp
| 6,653 |
Study Objectives
The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Vinflunine plus Capecitabine, DRUG: Capecitabine
Location: Poland, United Kingdom, South Africa, France, India, Belarus, Estonia, Ukraine, Spain, Czechia, Italy, Taiwan, Switzerland, Argentina, Brazil, Bulgaria, Belgium, Serbia, Russian Federation, Mexico, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* female patients
* 21 years or older
* histologically/cytologically confirmed carcinoma of the breast
* documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
* either one, two or three prior chemotherapy regimens
* prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs
* measurable or non-measurable disease according to RECIST 1.1
* Karnofsky performance score of at least 70 %
* adequate haematological, hepatic and renal functions
* ECG without clinically relevant abnormality
Exclusion Criteria:
* known or clinical evidence of brain metastasis or leptomeningeal involvement
* pulmonary lymphangitis or symptomatic pleural effusion
* any serious, concurrent uncontrolled medical disorder
* history of second primary malignancy
* preexisting motor/sensory peripheral neuropathy
* known history of HIV infection
* prior therapy with capecitabine and/or vinca-alkaloids
* history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs
* known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
* pregnancy or breast feeding
|
NCT_ID
NCT01095003
|
Study_NameTrial of Vinflunine Plus Capecitabine in Advanced Breast Cancer
| 16,547 |
Study Objectives
This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma
Intervention / Treatment:
DRUG: Paclitaxel Albumin-Stabilized Nanoparticle Formulation, OTHER: Laboratory Biomarker Analysis
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:
* Persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression
* Histologic confirmation of the original primary tumor
* Measurable disease, defined as at least one target lesion that can be accurately measured in at least one dimension >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, or >= 10 mm when measured by spiral CT scan
* Tumors within a previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy
* Must have received 1 prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or nonsquamous cell carcinoma of the cervix
* Chemotherapy administered as a radiosensitizer is not a systemic chemotherapy regimen
* Not eligible for a higher priority GOG protocol
* GOG performance status 0, 1, or 2
* No active infection requiring antibiotics
* Platelet count >= 100,000/mm^3
* Absolute neutrophil count >= 1,500/mm^3
* Creatinine <= 1.5 times upper limit of normal (ULN)
* Bilirubin <= 1.5 times ULN
* SGOT and alkaline phosphatase <= 2.5 times ULN
* No neuropathy (sensory and motor) > grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No evidence of any other invasive malignancies within the past 3 <= age <= 5 years, except localized breast cancer, head and neck cancer, cervical cancer, or nonmelanoma skin cancer
* No pre-existing hearing loss/tinnitus > grade 1
* No concurrent amifostine or other protective agents
* Recovered from effects of prior surgery, radiotherapy, or chemotherapy
* Hormonal therapy directed at malignant tumor must be discontinued at least 1 week prior to study entry
* Continuation of hormone replacement therapy permitted
* At least 3 weeks since prior biological therapy and immunotherapy
* No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
* May have received 1 additional noncytotoxic (biologic or cytostatic) regimen, including monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction
* No prior radiotherapy to any portion of the abdominal cavity or pelvis
* Radiotherapy for the treatment of cervical cancer within the past 5 years allowed
* Radiotherapy for localized breast cancer, head and neck or skin allowed provided completion > 3 years prior to study entry and remains free of recurrent or metastatic disease
* No prior chemotherapy for any abdominal or pelvic tumor
* Chemotherapy for the treatment of cervical cancer within the past 5 years allowed
* Prior adjuvant chemotherapy for localized breast cancer provided completion > 3 years prior to study entry and remains free of recurrent or metastatic disease
* No prior therapy with ABI-007 or any other taxane
* No prior anticancer treatment that would preclude study therapy
* No concurrent ritonavir, saquinavir, indinavir, nelfinavir, or anticonvulsants
|
NCT_ID
NCT00309959
|
Study_NameABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
| 14,903 |
Study Objectives
This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.
Conditions: Anemia
Intervention / Treatment:
DRUG: Sodium ferric gluconate, ferrous sulfate, standard of care
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Diagnosis of nonmyeloid malignancy
* Moderate to severe anemia
* Adequate iron stores as measured by either TSAT or ferritin
* About to start cycle of chemotherapy
* Eligible for epoetin alfa therapy
Exclusion Criteria:
* Highly elevated TSAT or ferritin
* Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
* Medical conditions that would confound the efficacy evaluation
|
NCT_ID
NCT00224068
|
Study_NameEffect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
| 9,798 |
Study Objectives
This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.
Conditions: Refractory Leukemia, Acute Myelogenous Leukemia
Intervention / Treatment:
DRUG: Panobinostat/LBH589
Location: Peru, Germany, United States, Spain, Australia, United Kingdom, Italy, Belgium, Turkey, France, Korea, Republic of, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Written informed consent prior to study-specific screening procedures
* Life expectancy of >= 60 days
* Eastern Cooperative Group (ECOG) performance status <= 2
* Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
* Negative serum pregnancy test (within 7 days of first dose)
* Negative urine pregnancy test immediately prior to first dose
Exclusion Criteria:
* Known HIV
* Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
* Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
* Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
* Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment
* Patient unable to swallow capsules
* Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat
Other Protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT00880269
|
Study_NameEfficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
| 9,060 |
Study Objectives
The purpose of this study is to evaluate whether adding olanzapine 5mg to standard antiemetic medication can significantly reduce chemotherapy-induced nausea and vomiting in breast cancer patients receiving emetogenic chemotherapy regimens such as anthracycline with cyclophosphamide-based chemotherapy and platinum-based chemotherapy.
To help clinicians prescribe antiemetic medications in a more patient-centered, evidence-based and cost-effective manner, we've developed the world's first validated risk-stratification tool for chemotherapy-induced nausea and vomiting (CINV) and because of this, it is now possible to perform a trial of personalized precision antiemetic therapy for breast cancer patients.
Despite widespread antiemetic use, chemotherapy-induced nausea and vomiting (CINV) remains among the most feared and expected side effects of chemotherapy for breast cancer. Inadequately controlled CINV can significantly reduce a patient's quality of life, impair functional activity, lead to chemotherapy dose delays and reductions, and even discontinuation of treatment. The merit of current antiemetic medications is based on their ability to control chemotherapy-induced vomiting, but not necessarily nausea, and nausea is the major issue for breast cancer patients.
With olanzapine demonstrating significant promise in preventing acute and delayed nausea, the investigators are proposing to evaluate guideline-recommended aprepitant-based triple regimen compared to the same regimen plus olanzapine (5 mg) for patients at high personal risk for CINV. For patients at low personal risk for CINV the investigators will also evaluate guideline-recommended double antiemetic regimen compared to the same regimen plus olanzapine (5 mg).
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Olanzapine, DRUG: Olanzapine Placebo
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
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Inclusion Criteria:
* Newly diagnosed invasive breast cancer (stage I-III) scheduled to receive neo/adjuvant anthracycline/cyclophosphamide or platinum-based chemotherapy
* >=18 years
* Able to provide consent and complete all study-related diaries and questionnaires.
Exclusion Criteria:
* Received previous chemotherapy
* Symptoms of nausea or vomiting at baseline
* On chronic antiemetic therapy (e.g. metoclopramide); on daily long term oral steroids prior to chemotherapy
* Allergic or having a medical condition that makes the administration of olanzapine, aprepitant, 5-HT3 antagonists or dexamethasone contraindicated
* Uncontrolled diabetes
* Known/documented medical/psychiatric illness that would interfere with patients' ability to complete the diary and study-related questionnaires.
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NCT_ID
NCT02861859
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Study_NameIndividualised Versus Standard Care for Breast Cancer Patients at High-risk for Chemotherapy-induced Nausea and Vomiting The ILIAD Study
| 11,976 |
Study Objectives
The purpose of this study is to test the safety of bevacizumab and sunitinib given in combination for kidney cancer. The drugs act to stop blood vessel growth but in different ways. They have not been studied together in a previous study. We also want to find out what effects (good and bad) the combination of bevacizumab and sunitinib have on you and your tumor.
Conditions: Metastatic Renal Cell Carcinoma, Kidney Cancer
Intervention / Treatment:
DRUG: Bevacizumab and Sunitinib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologically confirmed renal cell carcinoma (of any histological subtype) and with metastases. Patients with unresected primary tumors may be enrolled as long as evidence of metastatic disease is also present.
* Evidence of unidimensionally measurable disease (i.e., greater than or equal to 1 malignant tumor mass that can be accurately measured in at least 1 dimension greater than or equal to 20 mm with conventional computerized tomography [CT] or magnetic resonance imaging [MRI], or greater than or equal to 10 mm with spiral CT scan [if spiral CT scan is used, minimum lesion size should be twice the reconstruction interval used, e.g., if reconstruction size is 7 mm, lesion size should be greater than or equal to 14 mm]).
* Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
* Male or female, 18 years or older.
* ECOG performance status 0 or 1.
* Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade less than or equal to 1.
* Adequate organ function as defined by the following criteria:
* Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than or equal to 1.5 x upper limit of normal (ULN)
* Total serum bilirubin less than or equal to 1.5 mg/dL
* Total white blood cell count greater than or equal to 3000 cells/µL
* Absolute neutrophil count (ANC) greater than or equal to 1500/µL
* Platelets greater than or equal to 100,000/µL
* Hemoglobin greater than or equal to 9.0 g/dL
* Serum calcium less than or equal to 12.0 mg/dL
* Serum creatinine less than or equal to 2.0 x ULN
* PT less than or equal to 1.5 ULN
* Urine protein:creatinine ratio less than or equal to 1.0 at screening
* Negative pregnancy test (only in women of childbearing age)
* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
* Patients eligible for the higher priority IRB protocol #07 <= age <= 066
* Major surgery, open biopsy, traumatic injury, radiation or systemic therapy within 4 weeks of starting the study treatment. Anticipation of major surgical procedure during the study. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
* More than 2 prior systemic therapies for metastatic RCC.
* Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0.
* NCI CTCAE grade 3 hemorrhage within the past 1 month.
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
* History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis.
* Any of the following within the 12 months prior to study drug administration:
* severe/unstable angina, MI, CABG, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack or peripheral vascular disease.
* Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males and >470 msec for females.
* Blood pressure > 150/90mmHg
* Evidence of bleeding diathesis or coagulopathy
* Serious, non-healing wound, ulcer or bone fracture
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
* Current treatment on another therapeutic clinical trial.
* Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal, 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) within the 7 days 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 condition 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.
* Receipt of any investigational agent within 4 weeks prior to study entry.
* History of severe hypersensitivity reaction to bevacizumab or to any other component of bevacizumab.
* Prior treatment with sunitinib, bevacizumab
* Prior sorafenib given less than 8 weeks prior to study entry.
* Unresolved symptoms or signs related to sorafenib within 8 weeks prior to study entry.
* Use of therapeutic doses of coumadin.
* Inability to comply with study and/or follow-up procedures
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NCT_ID
NCT00421512
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Study_NameA Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients
| 13,071 |
Study Objectives
The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate:
* How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect breast tumors
* Side effects from adding bevacizumab to chemotherapy and trastuzumab
* Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart
* If receiving bevacizumab will have any effect on how patients recover from surgery
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Epirubicin, DRUG: Cyclophosphamide, DRUG: Docetaxel, DRUG: Trastuzumab, DRUG: Bevacizumab
Location: Canada, 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:
Conditions for eligibility for patients with LABC (Cohort A):
* The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
* Patients must have clinical Stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla that is greater than or equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.
Conditions for eligibility for patients with resected Stage III breast cancer (Cohort B)
* Patients must have undergone either a total mastectomy or a lumpectomy.
* Patients must have completed one of the following procedures for evaluation of pathologic nodal status.
* Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes, or
* Axillary lymphadenectomy without SN isolation procedure.
* The interval between the last surgery (for breast cancer treatment or staging) and study entry must be no more than 84 days.
* By pathologic evaluation, ipsilateral nodes must be pN2 or pN3.
* For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)
* For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
Conditions for patient eligibility (ALL patients)
* The patient must have consented to participate and must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
* Patients must be female.
* The patient must be greater than or equal to 18 years.
* The patient's ECOG performance status must be 0 or 1.
* The tumor must be invasive adenocarcinoma of the breast on histologic examination.
* The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using FISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.
* At the time of study entry, blood counts must meet the following criteria:
* Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.
* Platelet count must be greater than/equal to 100,000/mm3.
* Hemoglobin must be greater than/equal to 10 g/dL.
* The following criteria for evidence of adequate hepatic function must be met:
* total bilirubin must be less than/equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
* alkaline phosphatase must be less than 2.5 x ULN for the lab; and
* AST must be less than/equal to 1.5 x ULN for the lab.
* Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.
* Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, or PET scan) does not demonstrate metastatic disease, and has adequate hepatic function.
* Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or PET scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, MRI, or biopsy.
* Serum creatinine less than/equal to ULN for the lab.
* Urine protein/creatinine (UPC) ratio must be less than 1.0.
* All patients must have their LVEF assessed by 2-D echocardiogram within 3 months prior to study entry. (MUGA scan may be substituted for 2-D echocardiogram based on institutional preferences.) The LVEF must be greater than/equal to 55% regardless of the institution's LLN.
* Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if trastuzumab and bevacizumab therapy can be administered, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and to consider repeating the study if the accuracy is uncertain.
Exclusion Criteria:
Conditions for patient ineligibility (Cohort A)
* FNA alone to diagnose the primary tumor.
* Surgical axillary staging procedure prior to study entry. (Procedures that are permitted include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.
Condition for patient ineligibility (Cohort B)
* Breast reconstruction using tissue expanders or implants at the time of mastectomy.
Conditions for patient ineligibility (ALL patients)
* Definitive clinical or radiologic evidence of metastatic disease.
* Synchronous bilateral invasive breast cancer.
* History of ipsilateral or contralateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.
* History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
* Prior therapy with anthracyclines, taxanes, trastuzumab, or bevacizumab for any malignancy.
* Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
* Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible if these medications are discontinued prior to study entry.)
* Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 6 months after completion of targeted therapy.)
* Cardiac disease that would preclude the use of the drugs included in the FB-5 treatment regimen. This includes but is not confined to:
* Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions controlled by medication; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; and clinically significant valvular disease.
* History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; documented CHF; or documented cardiomyopathy.
* Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater han 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
* History of hypertensive crisis or hypertensive encephalopathy.
* History of TIA or CVA.
* History of other arterial thrombotic event within 12 months before study entry.
* Symptomatic peripheral vascular disease.
* Any significant bleeding within 6 months before study entry, exclusive of menorrhagia in premenopausal women.
* Serious or non-healing wound, skin ulcers, or bone fracture.
* Gastroduodenal ulcer(s) determined by endoscopy to be active.
* History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
* Anticipation of need for major surgical procedures (other than the breast surgery required for patients in Cohort A) during study therapy and for at least 3 months following completion of bevacizumab.
* Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.
* Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
* Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's CTCAE v3.0.
* Conditions that would prohibit administration of corticosteroids.
* History of hypersensitivity reaction to drugs formulated with polysorbate 80.
* Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed according to institutional standards for women of child-bearing potential.)
* Use of any investigational agent within 4 weeks prior to enrollment in the study.
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
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NCT_ID
NCT00464646
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Study_NameTherapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer
| 13,556 |
Study Objectives
The purpose of this study is to investigate whether an investigational drug called sunitinib malate is safe and effective in treating metastatic melanoma in patients with KIT mutations.
KIT is a gene that "codes for" (contains the genetic code that the body uses to make) a protein on the surface of cells in your body that is important in cell growth and cell division. The KIT protein seems to play a role in abnormal cell growth seen in acute leukemia, germ cell tumors, gastrointestinal stromal tumors (GIST), and certain melanomas. Melanomas that arise on acral skin (palms, soles, nail beds), mucosal membranes, and chronically sun damaged skin have recently been found to frequently contain mutations or increased copy numbers of the KIT gene. Your tumor tissue has previously been tested and has been found to contain abnormalities in the KIT gene.
Sunitinib malate is drug that has been shown to inhibit the activity of the KIT protein. The FDA approved sunitinib in 2006 for patients with GIST. It has been shown that sunitinib malate works in these patients because of its activity against the KIT protein. The FDA also approved Sunitinib malate in 2006 for the treatment of metastatic kidney cancer, where its effectiveness is probably due to its ability to block a different set of proteins.
Sunitinib malate has not been approved by the FDA for the treatment of metastatic melanoma.
Conditions: Metastatic Melanoma
Intervention / Treatment:
DRUG: Sutent (sunitinib)
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 confirmed advanced stage III or IV melanoma with primary origin in mucosal, acral-lentiginous, or chronic sun-damaged skin. Advanced disease is defined as locally recurrent disease or metastatic disease not amenable to surgical therapy. Patients may enter tumor-testing phase even if they do not have recurrent disease.
* Aberration of the KIT gene or KIT receptor on in-vitro testing of their tumor tissue.
* Evidence of measurable disease by RECIST criteria [Appendix 2]. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
* Resolution of all acute toxic effects of prior chemotherapy, immunotherapy, radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade <=1.
* Adequate organ function
* ECOG performance status 0 or 1.
Exclusion Criteria:
* Major surgery or radiation therapy within 2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
* NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
* Diagnosis of any second malignancy within the last 2 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer, or in situ cervical cancer.
* Active brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis on screening CT or MRI scan. Patients who have had central nervous system metastases treated by surgery or radiation therapy and with those CNS metastases considered in control will be eligible, provided measurable disease outside the CNS is present.
* Any of the following within the 2 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.
* Prolonged QTc interval on baseline EKG (>450 msec for males or >470 msec for females)
* Uncontrolled hypertension (> 160/100 mm hg despite optimal medical therapy).
* Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g., QOL, are allowed.
* Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg po daily for thromboprophylaxis is allowed).
* Pregnant or breastfeeding.
* Life expectancy less than 3 months.
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NCT_ID
NCT00631618
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Study_NameClinical Trial of Sutent to Treat Metastatic Melanoma
| 8,292 |
Study Objectives
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment of the donor bone marrow with the patient's white blood cells and a monoclonal antibody may prevent this from happening.
PURPOSE: Phase I trial to study the effectiveness of bone marrow transplantation with specially treated bone marrow in treating patients who have hematologic cancer that has not responded to previous therapy.
Conditions: Graft Versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myeloma
Intervention / Treatment:
DRUG: cyclophosphamide, DRUG: cyclosporine, DRUG: leucovorin calcium, DRUG: methotrexate, DRUG: methylprednisolone, PROCEDURE: in vitro-treated bone marrow transplantation, RADIATION: radiation therapy
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:
* Age <=40 years.
* Diagnoses-patients with the following hematologic malignancies and bone marrow failure syndromes:
* Acute myelogenous leukemia-induction failure, relapse, second or greater complete remission (CR)
* Acute lymphocytic leukemia-induction failure, relapse, second or greater CR, first CR with t(9;22), t(8;14), or t(4;11)
* Non-Hodgkin's lymphoma (intermediate or high grade) which has failed to achieve CR with at least two induction regimens, relapse, second or greater CR
* Multiple myeloma with poor prognostic features (elevated 0 <= age <= 2 microglobulin or high labeling index)
* Hodgkin's disease in relapse or which fails to achieve CR after two chemotherapy regimens
* Congenital or acquired bone marrow failure - poorly responsive to or intolerant of current therapy
* Myelodysplastic syndrome of all subtypes except refractory anemia (RA)
* Patient has a haploidentical family member that meets medical criteria for donation.
* Eligibility for other transplant types:
* Patient considered likely to have clinical deterioration and rapid disease progression during an unrelated donor search, or
* Patient who has already had an unproductive donor search or
* Patient ineligible for or has refused autologous transplant
* Adequate renal and hepatic function for age:
* Serum creatinine <2 x ULN
* Alanine aminotransferase (ALT, SGPT) x ULN
* Aspartate aminotransferase (AST, SGOT) x ULN
* Total bilirubin 5_2 x ULN except if bilirubin is elevated due to Gilbert's syndrome or hemolytic anemia
* Adequate cardiac and pulmonary function for age.
* ECOG Performance Status 0, 1, or 2 or Lansky performance scale >50% for patients <16 years.
* Voluntary witnessed written informed consent. Children will be asked for assent where appropriate.
* The patient, if female, must be post-menopausal, premenarcheal, or sterile, or if the patient is of childbearing potential, she must be practicing a method of birth control considered effective and medically acceptable by the investigator for a minimum of 1 month prior to study entry and at least 2 months after the study end.
* Patient must have undergone successful leukapheresis to obtain adequate antigen presenting cells.
* Any patient who enters the study in a relapse state, with evidence of end organ (pulmonary, renal, or hepatic) toxicity, or with recent recovery from infection, who may potentially have little benefit from this protocol, must have his/her eligibility status discussed with the Principal Investigator.
* Patient must have life expectancy of at least 12 weeks.
Exclusion Criteria
* Eligibility for other transplant types:
* Patient has family donor who is matched or single antigen mismatched at HLA-A, HLA-B, HLA-DR, and HLA-DQ. Donorrecipient matching must be evaluated via both phenotype and genotype.
* Patient has available unrelated donor who is matched at HLA-A, HLA-B, and HLA-DR. Donor-recipient matching must be evaluated via both phenotype and genotype.
* Active uncontrolled infection (continued positive blood or soft tissue cultures despite appropriate antibiotic treatment)
* Positive 13-HCG in a female of childbearing potential
* Evidence of HIV infection or known HIV positive serology
* Any prior bone marrow transplant
* A peripheral blood differential count at the time of leukapheresis with greater than 25% blasts. This exclusion criterion is valid only for the first four patients enrolled.
* Patients with Fanconi's anemia
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NCT_ID
NCT00005988
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Study_NameBone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Have Not Responded to Previous Therapy
| 18,243 |
Study Objectives
This study will determine the effects of soy products on in vitro surrogate cancer markers as well as bone density markers and quality of life parameters in men and women. This study will also determine concentrations of isoflavones (naturally occurring plant compounds that act like estrogen in the body) in prostate tissue that has been removed during prostatectomy, as well as in the blood.
Conditions: Breast Cancer, Prostate Cancer
Intervention / Treatment:
DRUG: Soy Isoflavone Nutritional Supplements
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: DOUBLE
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Inclusion Criteria
* Scheduled for prostatectomy
* Willing and able to consume study tablets for at least 2 weeks prior to surgery
* Willing to accept random assignment
* Signed informed consent
Exclusion Criteria
* Unwilling to avoid soy intake during the study period
* Currently taking antibiotics
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NCT_ID
NCT00200824
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Study_NameEffects of Soy Compounds on Breast Cancer, Prostate Cancer, and Bone Health
| 7,303 |
Study Objectives
This phase I trial studies the side effects and best dose of lenvatinib mesylate when given together with paclitaxel in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer that has come back or grown. Lenvatinib mesylate may stop the growth of tumor cells by blocking a protein needed for cell growth and may block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, 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. Giving lenvatinib mesylate and paclitaxel together may work better in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer.
Conditions: Fallopian Tube Carcinoma, Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma, Recurrent Endometrial Cancer
Intervention / Treatment:
DRUG: Lenvatinib Mesylate, DRUG: Paclitaxel, 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
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Inclusion Criteria:
* Women with histologically confirmed endometrial cancer, epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (all histological subtypes)who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to prior treatment
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >=10 mm with spiral computerized tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
* Patients must have received prior treatment with a platinum containing regimen and may have received an unlimited number of prior regimens (including prior taxanes)
* Patients with ovarian, Fallopian tube or primary peritoneal cancer must be platinum resistant (progression < 6 months after completion of a platinum containing regimen)
* Patients may have received prior targeted therapy such as bevacizumab
* Eastern Cooperative Oncology Group performance status =< 1
* Leukocytes >= 3,000/mcL (microliter)
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 100,000/mcL
* Hemoglobin >=8.0 g/dL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 × institutional upper limit of normal
* Creatinine < 1.5 mg/dL X ULN OR creatinine clearance >= 30 mL/min for patients with creatinine levels above institutional normal
* Urine protein by dipstick <1+ or UPC =< 1.0 by urinalysis
* Patients with chronic hypertension that is well controlled with systolic blood pressure of < 140 mmHg or diastolic blood pressure of < 90 mmHg, and in whom there has been no change in blood pressure medication in the last two weeks, are eligible
* Patients who have a history of deep vein thrombosis (DVT) or pulmonary embolus and are stable on anticoagulation for > 1 month are eligible
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NCT_ID
NCT02788708
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Study_NameLenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer
| 14,529 |
Study Objectives
The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.
Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response.
After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)
Conditions: Melanoma
Intervention / Treatment:
BIOLOGICAL: cyclophosphamide, fludarabine, T-cells, Interleukin-2
Location: Denmark
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:
* Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions.
Exclusion Criteria:
* Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
|
NCT_ID
NCT00937625
|
Study_NameT-cell Based Immunotherapy for of Melanoma
| 601 |
Study Objectives
Purpose of the Pilot Trial:
To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism (VTE) among cancer patients.
Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC.
Conditions: Upper Extremity Deep Vein Thrombosis, Central Venous Catheter Thrombosis, Cancer
Intervention / Treatment:
DRUG: Rivaroxaban 10 MG
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
*Patients 18 years or older with a new or existing diagnosis of cancer with a CVC inserted within the last 72 hours.
Exclusion Criteria:
* CVC in place for >72 hours
* Patient requires anticoagulation for other indication
* Concomitant use of dual antiplatelet therapy
* Prior VTE
* Major bleeding event in the last 6 weeks
* Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
* Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
* Known renal failure, based on Creatinine clearance <30 mL/min (Cockcroft-Gault) (in the previous 3 months)
* Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN) ( in the previous 3 months)
* Known thrombocytopenia < 50x 109/L (in the previous 3 months)
* Allergy to rivaroxaban
* Life expectancy <6 months
* History of condition at increased bleeding risk including, but not limited to:
1. Major surgical procedure or trauma within 30 days before the randomization visit
2. Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
3. History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
4. Chronic hemorrhagic disorder
5. Known intracranial neoplasm, arteriovenous malformation, or aneurysm
6. Sustained uncontrolled hypertension: systolic blood pressure >=180 mmHg or diastolic blood pressure >=100 mmHg
* Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome
* Geographic inaccessibility
* Refused or unable to obtain consent
|
NCT_ID
NCT03506815
|
Study_NameThromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines
| 18,066 |
Study Objectives
The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
Conditions: Unresectable Stage III or IV Malignant Melanoma
Intervention / Treatment:
DRUG: Ipilimumab, DRUG: Ipilimumab
Location: Peru, Israel, Sweden, United States, Italy, Denmark, Norway
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: DOUBLE
|
Inclusion Criteria:
* Histologic or cytologic diagnosis of unresectable State III or IV malignant melanoma (excluding ocular melanoma); A pre- and post-treatment fresh core or excision tumor biopsy must be provided.
|
NCT_ID
NCT00261365
|
Study_NamePhase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
| 2,167 |
Study Objectives
For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia blast percentage) at the time of HCT. This should lead to reduced relapse while still maintaining low transplant related mortality.
Conditions: Leukemia
Intervention / Treatment:
DRUG: Clofarabine
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:
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
* Adequate hepatobiliary function as indicated by the following laboratory values:
* SGOT/SGPT <=2.5 x upper limit of normal
* Alkaline phosphatase <=2.5 x upper limit of normal
* Serum bilirubin < 1.5 mg/dl
* Adequate renal function as indicated by the following laboratory values:
* Creatinine Clearance >50 ml/min
* Age >=18 years
* Zebroid performance status <= 2 (See Appendix A)
* Life expectancy is not severely limited by concomitant illness (i.e. < 3months life expectancy from non-leukemic conditions).
* No evidence of chronic active hepatitis or cirrhosis.
* HIV-negative
* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Exclusion Criteria:
* Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
* Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute non-hematologic toxicities from any previous .
* Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
* Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
* Pregnant or lactating patients.
* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
|
NCT_ID
NCT00724009
|
Study_NameClofarabine Bone Marrow Cytoreduction
| 17,614 |
Study Objectives
This clinical trial evaluates whether engineering gut microbiome using probiotics will alter the body's immune system to react to stage I-III breast or lung cancers that can be removed by surgery (operable). Having diverse species of bacteria inside the bowel may help improve the immune system, particularly the ability of the immune system to recognize cancer. Taking probiotics may change the diversity and make up of the bacteria in the bowels, and change how the immune system reacts to breast or lung cancer.
Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Adenocarcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
Intervention / Treatment:
PROCEDURE: Biopsy, PROCEDURE: Biospecimen Collection, DRUG: Probiotic, PROCEDURE: Therapeutic Conventional Surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* >= 18 years
* Histologically confirmed adenocarcinoma of the breast operable stage I-III or histologically confirmed carcinoma of the lung operable stage I-III will be enrolled prior to their definitive surgery
* Patients must have adequate organ function
* Patients must be willing to provide tissue, blood and stool samples for the research study
Exclusion Criteria:
* Patients must not receive systemic neoadjuvant therapy
* Patients must not have taken any probiotics in the past 30 days prior to the enrollment
* Patients with autoimmune disease, immune deficiency such as human immunodeficiency virus (HIV), irritable bowel, known diverticulosis, and other serious gastrointestinal (GI) conditions at treating physician's discretion will be excluded
|
NCT_ID
NCT04857697
|
Study_NameEffects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer
| 20,178 |
Study Objectives
The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Cyclosporins, DRUG: nab-paclitaxel
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
* Female or male patients with adenocarcinoma of the breast with metastatic disease.
* Patients may have evaluable or measurable disease.
* Age > 18 years.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Able to swallow and retain oral medication.
Exclusion Criteria
* Patients who have had any major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Prior nab-paclitaxel is allowed.
* Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.
* Patients with uncontrolled brain metastases or leptomeningeal disease or active neurologic impairment.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cyclosporine A or nab-paclitaxel.
* Pregnant or lactating (Cyclosporine A is excreted into breast milk) females
* Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
* HIV-positive patients are excluded since Cyclosporine A may result in further immunosuppression
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NCT_ID
NCT00983424
|
Study_NameCyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer
| 7,301 |
Study Objectives
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.
Another objective of the trial is to assess and compare the safety of each treatment.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: XELODA, DRUG: TEGAFUR URACIL - FOLINIC ACID
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* Locally advanced or metastatic colo-rectal cancer
* Age > or = 18 years
* PS-WHO < or = 2
* Polynuclear neutrophil leukocytes > or = 1500/mm3, platelets > or = 100000/mm3
* Total bilirubin < or = 3 ULN, ASAT-ALAT < or = 2.5 ULN
* Effective contraception
* Written informed consent signed
Exclusion Criteria:
* Concomitant radiotherapy
* Contraindication to fluoropyrimidines
* Treatment with sorivudine and its chemical analogs such as brivudine
* Severe hepatic insufficiency
* Severe renal insufficiency
* Pregnant or lactating woman
* Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients
|
NCT_ID
NCT00905047
|
Study_NameXeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer
| 21,131 |
Study Objectives
The goal of this clinical research study is to learn if combining the drugs thymoglobulin, methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS). The safety of this combination therapy will also be studied.
Conditions: Myelodysplastic Syndrome, Aplastic Anemia
Intervention / Treatment:
DRUG: Thymoglobulin, DRUG: Cyclosporine, DRUG: Methylprednisolone, DRUG: G-CSF
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:
* Diagnosis of severe aplastic anemia (bone marrow cellularity < 30%, with two of three peripheral counts at the time of initial presentation or currently low with absolute neutrophil count (ANC) < 500/mL, pre-transfusion platelet (PLT) < 20,000/mL, or pre-transfusion hemoglobin < 8 g/dL and presence of no other underlying disorder.
* Diagnosis of MDS (World Health Organization) with bone marrow cellularity < 30%, with two of three peripheral counts at the time of initial presentation or currently low with ANC < 500/mL, pre-transfusion PLT < 20,000/mL, or pre-transfusion hemoglobin < 8 g/dL.
* Patients with MDS who have received prior biological therapy (not chemotherapy) are eligible. Hypomethylating agents and histone deacetylase inhibitors are considered as biological therapy.
* Age 15 or greater
* Adequate renal function (creatinine less than or equal to 2.0 mg/dL) unless related to the disease
* Adequate hepatic function (bilirubin less than or equal to 3.5 mg/dL) unless related to the disease
* No other investigational therapy in the past 14 days
* Able to sign consent form
* Able to comply with the need for contraception (abstinence, condom, birth control pill, or other acceptable form of contraception) during the entire study period
* Diagnosis of MDS (WHO) with bone marrow cellularity greater than 30%, with low or intermediate-1 risk by the International Prognostic Scoring System (IPSS) score, and requiring treatment (i.e. transfusion-dependent)
Exclusion Criteria:
* Active and uncontrolled infection
* HIV positive test
* Pregnant or breast feeding
* Active and uncontrolled medical illness (pulmonary, cardiac, neurological, or other) that in the opinion of treating physician would likely interfere with study treatment
|
NCT_ID
NCT00806598
|
Study_NameThymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
| 22,509 |
Study Objectives
This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.
Conditions: Recurrent Prostate Cancer
Intervention / Treatment:
PROCEDURE: computed tomography, PROCEDURE: bone scan, PROCEDURE: 3-Tesla magnetic resonance imaging, PROCEDURE: diffusion-weighted magnetic resonance imaging, RADIATION: fluorine F 18 sodium fluoride, PROCEDURE: computed tomography, PROCEDURE: positron emission tomography, OTHER: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* History of prior radical prostatectomy for prostate cancer
* Two PSA values >= 0.2 ng/mL at least 4 weeks after prostatectomy
* Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan
Exclusion Criteria:
* Patients with known metastatic disease
* PSA recurrence not verified by elevated PSA as discussed in the eligibility section
* Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed
|
NCT_ID
NCT01967862
|
Study_NameFluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer
| 5,325 |
Study Objectives
This is an observational study of isolated thoracic perfusion with subsequent hemofiltration to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in malignant pleural mesothelioma.
Conditions: Mesothelioma
Intervention / Treatment:
DRUG: Chemotherapy
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* History of pre-treated Malignant Pleural Mesothelioma, Progress after Staging
Exclusion Criteria:
* Drug abuse, distant metastases, no bone marrow function
|
NCT_ID
NCT02467426
|
Study_NameIsolated Thoracic Perfusion (ITP-F) for MPM
| 2,624 |
Study Objectives
This phase II trials studies the side effects and how well ESK981 works in treating patients with castration-resistant prostate cancer that has spread to other places in the body. ESK981 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, PSA Progression, Stage IV Prostate Adenocarcinoma AJCC v7
Intervention / Treatment:
DRUG: ESK981
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:
* Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
* Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
* Eastern Cooperative Group (ECOG) performance status =< 1
* Patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising PSA (per PCWG3 criteria) and a castrate serum testosterone level (i.e. =< 50 mg/dL)
* Documented histologically confirmed adenocarcinoma of the prostate
* Metastatic prostate cancer (M1) as documented by appropriate medical imaging (i.e. computed tomography [CT]-scan, positron emission tomography [PET] scan or bone scan)
* Treatment failure of either abiraterone and/or enzalutamide as evidenced by a confirmed rising PSA (per PCWG3 criteria) and a castrate serum testosterone level (i.e. =< 50 mg/dL) while receiving treatment with either abiraterone and/or enzalutamide
* Willingness to use contraception by a method that is deemed effective by the Investigator throughout the treatment period and for at least 30 days following the last dose of therapy
* Willingness and ability to comply with study procedures and follow-up examination
* Able to swallow and retain oral medication
Exclusion Criteria:
* Current systemic therapy (other than a gonadotrophin releasing hormone [GnRH] agonist/antagonist) for CRPC including:
* CYP-17 inhibitors (e.g. ketoconazole, abiraterone)
* Antiandrogens (e.g. bicalutamide, nilutamide)
* Second generation antiandrogens (e.g. enzalutamide, ARN-509, Galeterone)
* Immunotherapy (e.g. sipuleucel-T, ipilimumab)
* Chemotherapy (e.g. docetaxel, cabazitaxel)
* Greater than 2 lines of prior systemic therapy for CRPC
* Prior chemotherapy (e.g. docetaxel, cabazitaxel) for CRPC; prior docetaxel administered in the castrate-sensitive space is allowed
* Prior radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153, etc.) within the past year
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
* Absolute neutrophil count (ANC) less than 1500/mm^3
* Platelet count less than 100000/mm^3
* Hemoglobin less than 9 g/dL
* Bilirubin greater than 1.5 times the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 times the ULN in the absence of known hepatic metastases, or ALT or AST greater than 3.0 times the ULN in the presence of known hepatic metastases
* The patient has a serum creatinine value greater than 1.5 mg/dL
* The patient has active brain metastases
* The patient is currently on warfarin or heparin therapy
* The patient has any pre-existing coagulopathy, recent hemoptysis, gross hematuria, or gastrointestinal bleeding, and a history of a clinically significant cardiovascular or cerebrovascular event within 12 months prior to study entry
* The patient has uncontrolled hypertension defined as a blood pressure measurement greater than 150 mm Hg systolic or 90 mm Hg diastolic with medication
* The patient has received any investigational drug within the past 4 weeks
* The patient has previously been enrolled in the study or received ESK981
* The patient has known hypersensitivity to gelatin or lactose monohydrate
* The patient has taken a medication known to be a potent inducer of CYP1A2, CYP2C8, or CYP3A4 within 4 weeks prior to the first dose of study drug
* The patient has taken a medication known to be a potent inhibitor of CYP1A2, CYP2C8, or CYP3A4 within 2 weeks prior to the first dose of study drug
|
NCT_ID
NCT03456804
|
Study_NameESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer
| 9,851 |
Study Objectives
This is a research study to evaluate the effects of ThermoDox in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in recurrent chest wall patients.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: ThermoDox in combination with Microwave Hyperthermia (heat)
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:
* Histologically documented recurrent/metastatic adenocarcinoma of the breast with a recurrence on the chest wall (or its overlying skin):
* Subjects with ulcerative chest wall disease defined as non-healing wounds consistent with cancer are eligible.
* Subjects with prior skin changes consistent with inflammatory breast carcinoma are eligible.
* Breast carcinoma for medical reasons not being resected
* Tumor thickness must be clinically indicated for hyperthermia therapy, as measured by clinical exam or imaging studies (CT or MRI). The target local tumor lesion(s) must be able to be covered within two hyperthermia fields of treatment.
* Disease that has progressed despite other available standard treatment options, based on what is clinically indicated according to the investigator's clinical and medical judgment, including:
* One or more radiation treatment(s) to the chest wall or breast up to a maximum prior dose of 12,000 cGy in the hyperthermia field (not administered less than 28 days prior to enrollment).
* Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.
* Subjects may have distant metastasis, including brain metastases. Subjects with known brain metastases are eligible if:
* They have received standard anti-tumor treatment for their brain metastases without encephalopathy;
* Their neurological function is stable for at least 30 days and either off steroid therapy or on a stable steroid regimen.
* Non-pregnant female at least 18 years. If the subject is of child-bearing age, must have a negative serum pregnancy test at baseline and must agree to practice an acceptable form of birth control while on the study.
* Provide written informed consent and willing to comply with protocol requirements.
Exclusion Criteria:
* Requires any concomitant antineoplastic therapy. Prior chemotherapy should not be administered within 5 half-lives or 28 days whichever is shorter. Subjects on a current stable dose of hormonal treatments may continue on a stable dose during the study (i.e. arimidex, amarosin, herceptin).
* Prior confirmed allergic reaction (including moderate rash, dyspnea, wheezing, urticaria or other symptoms) attributed to the administration of either anthracyclines or other liposomally encapsulated drugs that required discontinuation of prior therapy.
* Prior therapy with anthracyclines exceeding the following doses (subjects will be discontinued at 600 mg/m2 lifetime dose irrespective of the number of ThermoDox® cycles received):
Free (i.e., non-liposomal) or liposomal doxorubicin > 450 mg/m2 Free epirubicin > 900 mg/m2.
* Previous (required active treatment within 5 years) or concomitant malignancy except basal cell cancer, in situ carcinoma of the cervix, or contralateral breast cancer. Subjects with a prior contralateral breast malignancy can be included if they did not receive any chemotherapy.
* Baseline laboratories (repeat labs can be evaluated at baseline to establish eligibility):
* ANC Granulocytes < 1,500/ microliter
* Platelets < 75,000/ microliter
* Hemoglobin < 9 gm/dL
* Total Bilirubin > 2 mg/dL
* ALT and AST > 2.5 X upper limit of normal
* Creatinine > 1.5 X upper limit of normal.
* ECOG/Zubrod Performance Status > 2.
* MUGA/Echocardiogram Left Ventricular Ejection Fraction < 50%.
* Has a medical or psychiatric condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
* History of:
* Acute coronary syndrome
* Cerebral vascular accident
* Abnormal cardiac stress testing within last 6 months
* Symptomatic coronary artery disease
* Uncontrolled hypertension or cardiomyopathy
* Cardiac valvular surgery or open heart surgery
* Known structural heart disease.
* Has a condition which may interfere with the hyperthermia portion of the trial such as: functioning cardiac pacemaker; metal plates, rods or prosthesis of the chest wall, breast reconstruction with implants, severe numbness and/or tingling of the chest wall or breast, skin grafts and/or flaps on the breast or chest wall.
* Active infection requiring antibiotic treatment
* Has received any external radiation therapy within 28 days prior to enrollment.
|
NCT_ID
NCT00826085
|
Study_NamePhase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall
| 19,379 |
Study Objectives
Rationale: Seroma formation and its sequelae form the mainstay of complications in breast cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration of dead space. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and ultrasonic scalpel) or substances have proven to be superior in seroma reduction.
No prospective randomized controlled trials have been able to demonstrate which techniques are superior in reducing seroma and as a consequence patient discomfort in patients undergoing mastectomy. In a previous retrospective observational study these investigators demonstrated that mastectomy flap fixation significantly reduced seroma formation and the number of seroma aspirations. In a pilot study that was recently performed in one of the investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed promising results. The investigators hypothesize that obliteration of the dead space following mastectomy will significantly reduce seroma formation, its complications and the discomfort it causes patients undergoing mastectomy.
Conditions: Seroma, Aspiration, Breast Cancer
Intervention / Treatment:
DRUG: Artiss, PROCEDURE: vicryl sutures, PROCEDURE: Conventional
Location: Netherlands
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* >= 18 years years
* Female sex
* Indication for mastectomy or modified radical mastectomy
Exclusion Criteria:
* Patients undergoing breast conserving therapy
* Patients undergoing direct breast reconstruction
* Unable to comprehend implications and extent of study and sign for informed consent
|
NCT_ID
NCT03305757
|
Study_NameSeroma Reduction After Mastectomy
| 741 |
Study Objectives
This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates.
Conditions: Breast Cancer, Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Lapatinib, DRUG: Doxorubicin, DRUG: Cyclophosphamide, DRUG: Docetaxel, DRUG: Pegfilgrastim, DRUG: Filgrastim, DRUG: Dexamethasone, DRUG: Trastuzumab
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
* Female
* Histologically-confirmed Her2neu positive breast cancer, by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+
* Stage II/III breast cancer including any large primary tumor (> 2 cm), tumors of any size associated with skin or chest wall involvement, tumors of any size with axillary lymph node involvement, (T2-T4, N0-N2) and those with ipsilateral subclavicular or supraclavicular lymph nodes).
* At least one bi-dimensional, measurable indicator lesion.
* Between 18 and 70 years
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2 / Karnofsky >= 60% at screening and on the first day of treatment.
* Informed consent must be obtained prior to registration.
* Cardiac ejection fraction within the institutional range of normal as measured by multigated acquisition (MUGA) or echocardiography (ECHO) scan.
* Absolute neutrophil count > 1,500/mm³
* Hemoglobin > 8.0 g/dL
* Platelet count > 100,000/mm³
* Creatinine within normal institutional limits
* Total Bilirubin equal to or less than institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
* Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator
* Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing.
* All herbal (alternative) medicines are prohibited.
* Medications prohibited during the administration of lapatinib .
* Women of child-bearing potential must have negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.
* Peripheral neuropathy: must be < grade 1
* Able to swallow and retain oral medication
EXCLUSION CRITERIA
* Evidence of disease outside the breast or chest wall, except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes.
* Prior chemotherapy, immunotherapy, or hormonal therapy for breast cancer.
* More than 3 months between histologic diagnosis and registration on this study.
* History of other malignancy within the last 5years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol. Those who are medically-unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and those whose circumstances do not permit completion of the study or the required follow-up.
* Congestive heart failure, abnormal left ventricular ejection fraction (LVEF), angina pectoris, uncontrolled cardiac arrhythmias, or other significant heart disease, or who have had a myocardial infarction within the past year.
* Pregnant or lactating
* Of childbearing potential and not employing adequate contraception
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.
* HIV-positive and receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
* GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
* History of severe hypersensitivity reaction to taxotere or other drugs formulated with polysorbate 80.
* Current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment ).
|
NCT_ID
NCT00404066
|
Study_NamePhase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer
| 411 |
Study Objectives
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Drug: 99mTc-MIP-1404
Location: Poland, United States, Czech Republic, Italy, Netherlands, Belgium, Russian Federation, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Male aged >= 21 years.
* Ability to provide signed informed consent and willingness to comply with protocol requirements.
* Biopsy confirmed presence of adenocarcinoma of the prostate gland.
* At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130.
* Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
* Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc MIP-1404 injection.
Exclusion Criteria:
* Participating would significantly delay the scheduled standard of care therapy.
* Administered a radioisotope within 5 physical half lives prior to study drug injection.
* Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
* Have a contraindication for MR imaging.
|
NCT_ID
NCT01667536
|
Study_NameA Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
| 10,001 |
Study Objectives
This is a Phase I research study designed to determine the maximum tolerated dose (MTD) of cisplatin, temsirolimus, and erlotinib in combination for treatment in triple negative breast cancer (TNBC) patients.
Conditions: Triple Negative Breast Cancer
Intervention / Treatment:
DRUG: Temsirolimus, DRUG: Cisplatin, DRUG: Erlotinib
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:
* Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which the combination of cisplatin, temsirolimus, and erlotinib is a reasonable treatment.
* Patients with measurable or non-measurable disease are eligible for entry to this study. Tumor markers may be considered non-measurable disease.
* Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. No chemotherapy or radiotherapy may be given within 3 weeks prior to the start of protocol treatment.
* Patients must be >=18 years.
* Performance Status: Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 1
* Life expectancy of greater than 12 weeks.
* Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
* Required Laboratory Values: absolute neutrophil count (ANC) >=1,500/mm3, platelets >=100,000/mm3, hemoglobin >=9.0 g/dL, total bilirubin <=1.5 x upper limit of normal (ULN), aspartate transaminase (AST)/alanine transaminase (ALT) <=3.0 x ULN, alkaline phosphatase <=2.5 x ULN, creatinine <=2.0 x ULN OR Patients must have either a normal serum creatinine (<= IULN) OR estimated creatinine clearance 60 ml/min (Cockcroft-Gault formula) within 28 days prior to registration. Prothrombin time (PT)/INR <=1.5, unless the patient is on full dose warfarin or stable dose of low-molecular-weight (LMW) heparin with a therapeutic INR of >1.5 - <=3. Patients with triglyceride levels >400 mg/dL can be started on lipid lowering agents and reevaluated within 1 week. If levels go to <=400 mg/dL, they can be considered for the trial and continue the lipid lowering agents.
* Concomitant Medications: Temsirolimus and Erlotinib are primarily metabolized by CYP3A4. Patients CANNOT be receiving enzyme-inducing or enzyme inhibiting agents listed here: Inhibitors: Amiodarone, Amprenavir, Atazanavir, Chloramphenicol, Clarithromycin, Conivaptan, Cyclosporine, Darunavir, Dasatinib, Delavirdine, Diltiazem, Erythromycin, Fluconazole, Fluoxetine, Fluvoxamine, Fosamprenavir, Imatinib, Indinavir, Isoniazid, Itraconazole, Ketoconazole, Lapatinib, Miconazole, Nefazodone, Nelfinavir, Posaconazole, Ritonavir, Quinupristin, Saquinavir, Tamoxifen, Telithromycin, Troleandomycin, Verapamil, Voriconazole. Inducers: Aminoglutethimide, Bexarotene, Bosentan, Carbamazepine, Efavirenz, Fosphenytoin, Griseofulvin, Modafinil, Nafcillin, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Rifapentine, St. John's wort, Sulfadimidine, Sulfinpyrazone, Troglitazone, Troleandomycin. All concomitant medications must be recorded. Patients also must agree to refrain from drinking grapefruit juice while on study.
* Sexually Active Patients: For all sexually active patients, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation. Non-pregnant status will be determined in all women of childbearing potential.
* Patients must have signed an approved informed consent.
Exclusion Criteria:
* More than 3 prior chemotherapy treatments for metastatic disease.
* Patients receiving anti-retroviral therapy (HAART) for HIV infection because of possible pharmacokinetic interactions.
* Active central nervous system (CNS) disease
* Any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
* Patients pregnant or nursing.
* Patients who have used tobacco or nicotine products containing medications within the last three months given their significant effect on erlotinib drug levels.
|
NCT_ID
NCT00998036
|
Study_NameStudy of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors
| 7,559 |
Study Objectives
The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The therapy in this study is based upon treatment information learned from prior clinical research programs as well as from laboratory research.
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: prednisone, DRUG: dexamethasone, DRUG: doxorubicin, DRUG: E. coli asparaginase, DRUG: vincristine, DRUG: methotrexate, DRUG: Leucovorin, DRUG: Asparaginase, DRUG: cytarabine, DRUG: Methotrexate/Hydrocortisone
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Acute lymphoblastic leukemia excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14) (q24;q32), t(8;22) or t(2;8)
* Age > 12 months but less than 18 years
Exclusion Criteria:
* Prior therapy except, 1 week of steroids, or emergent radiation therapy to the mediastinum
* Known HIV positive
|
NCT_ID
NCT00165178
|
Study_NameTreatment of Acute Lymphoblastic Leukemia in Children
| 17,857 |
Study Objectives
This study will test the use of a web-enabled app that is integrated directly with patients' electronic health records, with and without tailored feedback. The app-based intervention is designed to improve patient-provider communication outside of clinic visits, resulting in improved symptom management and adjuvant endocrine therapy adherence among diverse patients with hormone receptor-positive breast cancer. The researchers will evaluate the impact of the intervention on a comprehensive set of outcomes, including rigorous measures of long-term adherence, quality of life, and costs.
Conditions: Breast Neoplasm Female
Intervention / Treatment:
BEHAVIORAL: THRIVE App, BEHAVIORAL: Tailored Feedback Messages
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Adult female patients (age>=18)
* Diagnosis of ductal carcinoma in situ or Stage I-III hormone receptor-positive breast cancer
* New prescription for an aromatase inhibitor or tamoxifen
* Have a mobile device with a data plan or a home computer with Internet
* Have a valid email address
* Willing to complete brief surveys on a web-enabled device
* AET is indicated as standard of care
Exclusion Criteria:
* Unable to communicate in English
* Prior use of adjuvant endocrine therapy (aromatase inhibitor or tamoxifen) for current diagnosis
* Concurrently undergoing surgery, chemotherapy or radiation
* Current diagnosis of rheumatoid arthritis
* Chronic daily narcotic usage
* Patient plans to move or transfer their care within the next year
|
NCT_ID
NCT03592771
|
Study_NameTHRIVE Breast Cancer App Study
| 17,967 |
Study Objectives
This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor.
The main purpose of this study is to evaluate the safety and tolerability of tumor injections of INXN-2001 given in combination with different doses of INXN-1001.
Conditions: Melanoma
Intervention / Treatment:
BIOLOGICAL: INXN-2001, DRUG: INXN-1001
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:
* Males or females of all races >= 18 years, who have provided written informed consent prior to completing any study specific procedure.
* Unresectable Stage III or Stage IV melanoma arising from any site other than ocular melanoma.
* A minimum of 2 accessible nonvisceral lesions (shortest diameter >=1 cm) or palpable tumor-involved lymph nodes (shortest diameter >=1.5 cm).
* ECOG performance status of 0 or 1 (Appendix 1).
* Adequate bone marrow, liver, and renal function.
* An expected survival of at least approximately 6 months.
* Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate less than 5% per year) from the screening visit through 28 days after the last dose of study drug.
Exclusion Criteria:
* Any prior anti-cancer therapy or investigational agent within 28 days prior to the first dose of study drug. (NOTE: For the expansion cohort ONLY, if subjects received ipilimumab, a 90-day washout period since last dose of ipilimumab is required. If subjects received other immunomodulating therapies (eg, anti-PD1 antibodies), the medical monitor should be contacted and an evaluation will be made.)
* Clinically significant infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks of the first dose of study drug.
* History of HIV infection.
* Active autoimmune disease requiring steroids (>10 mg prednisone or comparable) or other immunosuppressive therapy (e.g., methotrexate, etc.).
* Documented symptomatic brain metastases. Screening for brain lesions by CT or MRI is not required for all potential subjects; however, if there are any neurological signs or symptoms consistent with brain metastases, then a brain CT or MRI should be performed as clinically indicated.
* Any medications that induce, inhibit or are substrates of CYP450 3A4 within 7 days prior to the first dose of study drug.
* Prior history of hematopoietic stem cell transplant or organ allograft.
* Other concurrent clinically active malignant disease, with the exception of other cancers of the skin.
* Females who are nursing or pregnant.
* Subjects who have a history of hypersensitivity that may relate to any component of the study drugs, e.g. to benzoic acid since INXN-1001 contains two benzene rings.
* Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
|
NCT_ID
NCT01397708
|
Study_NameSafety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma
| 13,267 |
Study Objectives
The purpose of this study is to determine how the human body processes and eliminates the drug (BMS-690514.
Conditions: Cancer
Intervention / Treatment:
DRUG: EVRI (BMS-690514)
Location: Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Healthy male subjects
* Body mass index (BMS) of 18 - 30 kg/m², inclusive
Exclusion Criteria:
* Radiation exposure from diagnostic X-rays (except dental X-rays) in the last year or from clinical trials in the last 5 years
|
NCT_ID
NCT00578916
|
Study_NamePharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male Subjects
| 6,950 |
Study Objectives
This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.
Conditions: Advanced or Recurrent Solid Tumors
Intervention / Treatment:
DRUG: vadimezan
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel
* WHO Performance Status of 0 <= age <= 1
Exclusion Criteria:
* Patients having symptomatic CNS tumor/metastasis and requiring treatment
* Patients who have received prior therapy with ASA404 or other vascular disrupting agents
* Patients with systolic BP > 160mmHg and/or diastolic BP > 90mmHg
* Patients with fluid retention
* Patients with any one of cardiotoxicities
* Concomitant use of drugs with a risk of prolonging the QT interval
* Known allergy or hypersensitivity to taxane or polysorbate 80
Other protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT01285453
|
Study_NameSafety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors
| 22,164 |
Study Objectives
This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.
Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer
Intervention / Treatment:
DRUG: Gemcitabine Hydrochloride, DRUG: Cisplatin, RADIATION: Radiation Therapy, RADIATION: Internal Radiation Therapy
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 primary invasive carcinoma of the uterine cervix
* Previously untreated disease
* Any cell type
* Stage IB_2, IIA, IIB, IIIA, IIIB, or IVA
* Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy
* No known metastases to scalene nodes or other organs outside the radiotherapy field
* Study enrollment within 8 weeks of diagnosis
* Performance status - GOG 0 <= age <= 2
* Absolute neutrophil count at least 1,500/mm^3
* Platelet count at least 100,000/mm^3
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Creatinine less than 2.0 mg/dL
* No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields
* No ureteral obstruction allowed unless treated with stent or nephrostomy tube
* Not pregnant
* Fertile patients must use effective contraception
* No septicemia or severe infection
* No circumstance that would preclude study completion or follow-up
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No prior cytotoxic chemotherapy
* No prior pelvic or abdominal radiotherapy
* No prior therapy for this malignancy
|
NCT_ID
NCT00068549
|
Study_NameRadiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
| 15,035 |
Study Objectives
Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.
Conditions: Gastric Cancer
Intervention / Treatment:
DRUG: DCS (docetaxel with cisplatin with TS-1), DRUG: DCF (docetaxel with cisplatin with 5-FU)
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histologically/cytologically confirmed gastric adenocarcinoma
* Age 18 <= age <= 70 old
* ECOG performance Status 0~1
* Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0 <= age <= 3 (IIIA~IV), M0, P0, H0, CY0
* No pretreatment (radiotherapy or chemotherapy) for gastric cancer
* Adequate organ function
* Hb >= 9.0 g/dL
* WBC >= 4,000/µL
* ANC >= 2,000/µL (*ANC = Neutrophil segs ＋ Neutrophil bands)
* Platelet >= 100 × 103/ µL
* Total bilirubin: <= 1.5 × UNL
* CCr >= 60 ml/min (by laboratory or Cockcroft-Gault Formula)
* AST/ALT, ALP: <= 2.5 × UNL
* Written informed consent
Exclusion Criteria:
* Distant metastasis on diagnosis
* cT1 <= age <= 2
* Cancer of gastroesophageal junction (GEJ)
* Poor oral intake or absorption deficiency syndrome
* Gastric outlet obstruction, perforation or bleeding
* Medically uncontrollable chronic illness or infection
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* History of clinically significant cardiac disease
* Past or concurrent history of neoplasm last < 5 year other than gastric cancer
* Prior gastrectomized patients
* Concomitant administration of any other experimental drug under investigation
* Peripheral neuropathy >= NCI-CTC grade 2
|
NCT_ID
NCT01286766
|
Study_NameNeoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
| 2,760 |
Study Objectives
Objective:
To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific ≥ grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period. The adherence to the study creams will also be studied.
Conditions: Cancer, Skin Rash
Intervention / Treatment:
OTHER: dexpanthenol 5% cream, OTHER: Cetomacrogol cream
Location: Netherlands
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Male and female subjects
* >=18 years.
* Patients must have signed an approved informed consent form prior to registration on study.
* Histological proof of cancer.
* A planned course of EGFRI treatment for any type of cancer. Patients must be entered on study <= 7 days before EGFRI treatment begins.
* Have an Eastern Co-operative Oncology Group (ECOG) performance status <= 2.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Patients need to be free of infection and not using any topical treatments on the skin.
Exclusion Criteria:
* Use of other concurrent topical creams or lotions at baseline.
* Concomitant use of medications that may affect trial results (e.a. concurrent use of topical antibiotics, topical steroids, and other topical treatments on face and chest within 14 days of Day 0 (baseline); treatment with any systemic antibiotics within 7 days prior to Day 0.
* Active dermatological conditions other than papulopustular eruption that may affect trial results. A skin examination reveals the presence of another skin disease in face or chest that may obscure rash to EGFRI and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the skin that, in the study physician's opinion, would confound the evaluation of the papulopustular eruption.
* Known allergy or hypersensitivity to ingredients in Bepanthen® or Cetomacrogol.
* Known sensitivity, papulopustular eruption or other abnormal skin reaction to topical or systemic medications or cleansing products at baseline.
* Prior treatment with targeted therapy of any kind.
* Current use of agents that are known to be strong inducers or inhibitors of CYP3A4 that can not be stopped
|
NCT_ID
NCT01136005
|
Study_NameBepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)
| 21,751 |
Study Objectives
The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: Aprepitant / Fosaprepitant
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Age: >=20 years
* Sex: Not specified
* Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at >=85 mg/m2 (naive patient), or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course (non-naive patient).
* Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type are allowed)
* Combination of molecular targeted therapy: allowable
* Written informed consent for participation in the study.
Exclusion Criteria:
* Severe liver or kidney disease
* Nausea/vomiting within 24 hr prior to chemotherapy.
* Treatment with antiemetics within 24 hr prior to chemotherapy.
* Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)
* Presence of a disease precluding 3-day administration of dexamethasone (e.g. uncontrollable diabetes)
* Pregnant or lactating women, women who plan to become pregnant.
* Current treatment with pimozide.
* Any patient judged to be inappropriate for the study by the investigator.
|
NCT_ID
NCT01344304
|
Study_NameStudy of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
| 6,097 |
Study Objectives
This is a first-in-human, pilot study of the feasibility and safety of dapagliflozin (in addition to standard of care treatment) for the treatment of patients with metastatic pancreatic ductal adenocarcinoma. The primary hypothesis is that dapagliflozin is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious as an adjunct to front-line chemotherapy assessed by decreased tumor markers mediated by its pleiotropic metabolic effects.
Conditions: Pancreas Cancer, Pancreatic Cancer, Cancer of the Pancreas
Intervention / Treatment:
DRUG: Dapagliflozin, DEVICE: BIOSENSE meters
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 or cytologically confirmed metastatic or locally advanced pancreatic ductal adenocarcinoma, pancreatic adenosquamous carcinoma or squamous cell carcinoma
* Patients with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry, are eligible.
* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with CT scan, as >= 20 mm by chest x-ray, or >= 10 mm with calipers by clinical exam.
* No prior systemic therapy for pancreatic ductal adenocarcinoma in the metastatic or locally advanced setting.
* Planning to receive treatment with nab-paclitaxel and gemcitabine.
* At least 18 years.
* ECOG performance status <= 1
* Normal bone marrow and organ function as defined below:
* Leukocytes >= 3,000/mcL
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 100,000/mcL
* Total bilirubin <= 1.5 x IULN
* AST(SGOT)/ALT(SGPT) <= 3.0 x IULN
* Estimated glomerular filtration rate eGFR >= 30 mL/min/1.73m^2
* Because chemotherapeutic agents such as nab-paclitaxel and gemcitabine are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and at least one month after completion of the study
* Agreement to adhere to Lifestyle Considerations throughout study duration
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* History of total pancreatectomy
* Current or previous treatment with SGLT2i or thiazolidinedione.
* Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone. Note that dexamethasone that can be prescribed for nausea on the day of chemotherapy, but in subsequent days will be replaced by a nonsteroidal anti-emetic for patients in this trial. Topical steroid ointments or creams for occasional skin rash is allowed.
* A history of other malignancy with the exceptions of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma.
* History of stroke or transient ischemic attack (in the last 5 years).
* HbA1c > 10% unless approved by endocrinologist
* Currently receiving any other investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin, nab-paclitaxel, gemcitabine or other agents used in the study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m2), symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
|
NCT_ID
NCT04542291
|
Study_NameTargeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition
| 5,937 |
Study Objectives
The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.
Conditions: Kidney Neoplasms
Intervention / Treatment:
DRUG: SU-011,248
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:
* Eligible patients must be at least 18 years with a diagnosis of metastatic kidney cancer.
* The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
* Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function
Exclusion Criteria:
* Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
* Prior surgical resection of or irradiation to the only site of measurable disease;
* Ongoing severe hematuria;
* Other active second malignancy;
* Cardiovascular diseases or conditions within the last 12 months;
* Known brain metastases;
* Known HIV-positive or AIDS-related illness;
* Pregnant or breast-feeding women;
* Current participation in other clinical trials;
* Other severe acute or chronic medical conditions.
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NCT_ID
NCT00054886
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Study_NameStudy of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
| 4,193 |
Study Objectives
This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus ledipasvir (genotype 1 and 4) or sofosbuvir plus velpatasvir (genotype 2 and 3) for patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive).
Conditions: Indolent B-cell Lymphoma, Hepatitis C
Intervention / Treatment:
DRUG: Ledipasvir+Sofosbuvir, DRUG: Sofosbuvir+Velpatasvir
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age >18 years
* Indolent B cell lymphoma including: marginal zone lymphoma (nodal, extranodal, splenic and disseminated), lymphoplasmacytic lymphoma, small lymphocytic lymphoma, follicular lymphoma grade 1 and 2, CD5-negative B-cell lymphoma NOS
* HCV-RNA positivity
* Assessable HCV genotype
* No previous therapy for the lymphoma
* Measurable disease after diagnostic biopsy (longest axis >=1.5 cm for nodal and >=1 cm for extranodal lesions) and/or evaluable disease (quantifiable BM infiltrate and >=5 x 109/l clonal B-cell in peripheral blood in case of exclusive BM/leukemic disease in CD5-negative Bcell lymphoma NOS)
* No need of immediate lymphoma treatment defined as absence of all the following criteria: systemic symptoms, bulky nodal or extranodal mass (>7 cm), symptomatic splenomegaly, progressive leukemic phase, serous effusions
* Performance status <2 according to ECOG scale
* Adequate hematological counts: ANC >1 x 109/L, hemoglobin >9 g/dl (transfusion independent), platelet count > 50 x 109/L (transfusion independent)
* No central nervous system (CNS) disease (meningeal and/or brain involvement by lymphoma)
* Adequate kidney function (creatinine clearance >= 45 ml/min)
* Cardiac ejection fraction >=45% (echocardiography or MUGA scan)
* Normal lung function
* Non peripheral neuropathy or active neurological non neoplastic disease of CNS
* Non major surgical intervention prior 3 months to enrolment if not due to lymphoma and/or no other disease life-threatening that can compromise chemotherapy treatment
* Disease free of prior malignancies other than lymphoma for >3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
* Life expectancy > 6 months
* No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
* Written informed consent
* Women must be:
* postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months)
* surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
* completely abstinent (at the discretion of the investigator/per local regulations) (periodic abstinence from intercourse is not permitted) or
* if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be prepared to continue birth control measures for at least 6 months after terminating treatment.
* Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening
* Men must agree to use an acceptable method of contraception (for themselves or female partners as listed above) for the duration of the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 1 month after receiving the last dose of study drug if not taking ribavirin of for 6 months after receiving the last dose of study drug if taking ribavirin.
Exclusion Criteria:
* Diagnosis of lymphoblastic lymphoma, Burkitt lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma grade 3, primary mediastinal B-cell lymphoma
* Previous anti-HCV treatment with sustained virological response
* Diagnosis of cirrhosis (histological or Stiffness >12 KpA)
* CNS disease (meningeal and/or brain involvement by lymphoma)
* History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
* Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
* Concomitant therapy with amiodarone
* Uncontrolled or severe cardiovascular disease including myocardial infarction within six months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina,
* Cardiac ejection fraction <45% (MUGA scan or echocardiography).
* Creatinine clearance <45 ml/min
* Presence of major neurological disorders
* HIV positivity, HBV positivity (HbsAg+ or HBV-DNA+) with the exception of HBcAb+, HbsAg-, HBsAb+/- patients with HBV-DNA negativity
* Ongoing systemic bacterial, fungal or viral infections at the time of initiation of study treatment (defined as requiring therapeutic dosing of an antimicrobial, antifungal or antiviral agent)
* Major surgical intervention prior 3 months to enrollment if not due to lymphoma and/or other
* Prior malignancies other than lymphoma in the last 3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
* Life expectancy <6 months
* Any other coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
* If female, the patient is pregnant or breast-feeding.
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NCT_ID
NCT02836925
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Study_NameLedipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection
| 14,759 |
Study Objectives
The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with at least 44 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (second and third line Lower risk MDS).
Conditions: Myelodysplastic Syndrome
Intervention / Treatment:
DRUG: OPN-305
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:
* Written informed consent
* Age >= 18 years
* Diagnosis of MDS (de novo or secondary) by bone marrow aspirate based on the World Health Organization (WHO) classification - Low and Intermediate-1 risk categories MDS using the IPSS (International Prognostic Scoring System)
* AZA/decitabine (this applies to standard of care and investigational drugs) failure (Dose confirming and Dose expansion parts):
* defined as discontinuation due to any of the following:
* Lack of response after at least 4 cycles
* Loss of response (patient must have received therapy for at least 4 cycles)
* Progressive disease
* Adverse events
Note: Patients are eligible if additionally they have failed an ESA
* HMA Naïve group:
* Never received a hypomethylating agent for MDS
* Failed or ceased to respond to ESA(s)
* ESA ineligible; defined as endogenous serum erythropoietin level > 200 U/L for subjects not previously treated with ESAs
* Red blood cell transfusion dependent defined as >= 2 Red blood cells (RBC) units required in the 8 weeks prior to starting in the study. In addition, there should be no 8 consecutive weeks without red blood cell transfusions in the 16 weeks prior to enrolment.
* Life expectancy >= 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 <= age <= 2
* Serum bilirubin levels <=2 x upper limits of normal (ULN)
* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels <=2.5 x ULN
* Del 5q patients who have failed or are not eligible for Revlimid
* Creatinine clearance >30 ml/min calculated by the Cockcroft-Gault formula
* Willingness to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
* Negative urine β-human chorionic gonadotropin (β-HCG) pregnancy test for fertile women at screening and confirmed by serum pregnancy test in the 48 hours prior to OPN-305 administration
* If sexually active female, patient must be/have one of the following:
* Post-menopausal defined as the absence of menses for at least one year (serum Follicle-stimulating hormone (FSH) >=20IU/L can also be measured according to local practice),OR
* Surgically sterile defined as a bilateral tubal ligation at least 6 months prior to administration of study drug, bilateral oophorectomy, or complete hysterectomy, OR
* Using an effective means of contraception that is planned to continue for the duration of treatment and for a further 3 months.
* If sexually active male, patient must: Agree to use an effective means of contraception (per site-specific guidelines) that is planned to continue until 6 months after the last dose of OPN-305.Agree not to donate sperm until 6 months after the last dose of OPN-305
Exclusion Criteria:
* Diagnosis of MDS by bone marrow aspirate of Intermediate-2 and High risk category MDS based on the World Health Organization (WHO) classification using the IPSS (International Prognostic Scoring System)
* Patients with 5q deletion (del) MDS eligible for Revlimid (lenalidomide)
* Hypomethylating agent (HMA) Naïve group:
* Have received a hypomethylating agent for MDS
* Have not failed or ceased to respond to an ESA
* Are not ESA ineligible as defined in inclusion criteria
* Prior history of acute leukemia or AML
* Unable/unwilling to undergo bone marrow sampling
* Prior history of bone marrow transplantation
* Prior malignancy (other than non-invasive malignancy including in situ cervical cancer, Bowen's disease, basal cell cancer of the skin and non-invasive or excised skin squamous cell carcinoma) unless treated with curative intent and without evidence of disease for 3 years before randomization
* Active viral or bacterial infections: this includes any infections that are being actively treated even if the signs and symptoms appear to have resolved. Courses of antibiotics or anti-viral treatment should be completed before the patients is enrolled
* 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, uncontrolled diabetes mellitus
* Clinical Evidence of Central Nervous System (CNS) disease
* Less than 4 weeks since any therapy for MDS
* Prior history of anaphylaxis to similar products
* History or presence of a medical condition or disease or substance abuse that in the investigator's assessment would place the patient at an unacceptable risk for study participation
* Lactating or pregnant woman
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NCT_ID
NCT02363491
|
Study_NameA Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome
| 5,535 |
Study Objectives
This is a multicenter, single arm, 3-cohort, open-label trial of high dose Vitamin C intravenous infusion in subjects with solid tumor malignancies who are eligible for resection (cohort A) or with extended RAS (e.g.KRAS or NRAS) or BRAF mutation metastatic cancer who have received prior systemic treatment (cohort B). Cohort C will involve patients with colorectal cancer having an extended RAS or BRAF mutation who are amenable for localregional therapy of hepatic metastases with Yttrium-90 radioembolization.
Conditions: Colorectal Cancer, Pancreatic Cancer, Lung Cancer
Intervention / Treatment:
DRUG: Vitamin C
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
* Male or female >= 18 years.
* Patients with histologically proven early stage or locally advanced colorectal adenocarcinoma, lung cancer or pancreatic cancer, who are eligible for resection (cohort A).
* Patients with inoperable, metastatic extended RAS (e.g. KRAS or NRAS) or BRAF mutant colorectal adenocarcinoma, lung cancer and pancreatic cancer, or other solid tumor, who have received at least 1 line of treatment for metastatic disease (cohort B).
* Patients with metastatic cancer with an extended RAS (e.g. KRAS or NRAS) or BRAF mutation with liver metastases amenable to Y90 radioembolization (cohort C).
* ECOG performance status 0 <= age <= 1.
* Life expectancy of at least 6 months.
* All women of child-bearing potential and all sexually active male patients must agree to use effective contraception.
Exclusion Criteria:
* Patients with uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (Appendix B: New York Heart Association (NYHA) Classifications).
* Patients with active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV) (Appendix B: New York Heart Association (NYHA) Classifications).
* Patients who have received an investigational drug within 21 days of the first dose of study drug.
* Patients who are pregnant or lactating.
* Patients who are known to be positive for the human immunodeficiency virus (HIV). The effect of Vitamin C on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study.
* Patient who are receiving drugs which are known to interact with Vitamin C, potential risk and eligibility will be evaluated individually by the investigator. a. Most of the known interactions with vitamin C are from oral use and acidification of the stomach lining. There are few known interactions with high dose intravenous vitamin C. We recommend not using deferoxamine as there may be an association with ventricular dysfunction (unknown mechanism).
* Patients who have uncontrolled or severe hyponatremia, hypernatremia, SIADH, hypokalemia, hyperkalemia, hypomagnesemia, or hypermagnesemia
* Patients who have uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, such as hemoptysis, epistaxis, hematochezia, hematuria, or gastrointestinal bleeding.
* Patients who require therapeutic doses of warfarin
* Patients who have uncontrolled seizure disorder, ascites, iron overload, edema, or dehydration.
* Patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary spherocytosis, or other conditions predisposing patient to hemolysis.
* Patients who have a known history of recurrent oxalate renal calculi or multiple oxalate.
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NCT_ID
NCT03146962
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Study_NameHigh Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies
| 3,105 |
Study Objectives
In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: Epirubicin, DRUG: Albumin-bound Paclitaxel
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:
To be included in this study, you must meet the following criteria:
* Locally advanced/inflammatory adenocarcinoma of the breast
* 18 years or older
* Normal heart function
* Able to perform activities of daily living with minimal assistance
* No prior chemotherapy for breast cancer
* Adequate bone marrow, liver and kidney function
* No evidence or history of significant cardiovascular abnormalities
* Sentinel node or axillary dissection
* Sign an informed consent form
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Pregnant or breast feeding
* History of heart disease with congestive heart failure
* Heart attack within the previous 6 months
* Prior chemotherapy or hormone therapy for breast cancer
* History of active uncontrolled infection
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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NCT_ID
NCT00193206
|
Study_NameNeo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
| 12,259 |
Study Objectives
Patients with histologically proven malignancy with documented disease control (objective response or stable disease) or Not Evaluable Disease (NED) expectancy \> 6 months; only HLA-A\*02 positive patients.
The primary objective of the trial is to compare safety and tolerability of four different doses of Vx-006. The secondary objective is to compare immunogenicity of four different doses of the Vx-006.
Conditions: Solid Tumor
Intervention / Treatment:
DRUG: Vx-006: 0,5mg, DRUG: Vx-006: 1mg, DRUG: Vx-006: 5mg, DRUG: Vx-006: 10mg
Location: Greece
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 > or = 18 years;
* Histologically proven malignancy;
* Documented HLA-A*02 positivity, as determined by a central laboratory;
* Disease control (Complete Response (CR), Partial Response (PR), or Stable Disease (SD)) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria or NED in the case of patients who received adjuvant chemotherapy
* Patient with disease control or NED expectancy > or = 6 months according to investigator opinion;
* ECOG performance status 0, 1;
* Patients must have adequate renal and hepatic function as assessed by standard laboratory criteria;
* Patients must have adequate haematological function:
* Platelet count > or = 100 x 109/L;
* White Blood Cell (WBC) count > or = 2.5 x 109/L;
* Haemoglobin > or = 90g /L;
* Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential must have a negative urine pregnancy test at baseline and agree to practice adequate contraception for 30 days prior to administration of investigational product, throughout the study treatment period and 30 days after completion of injections;
* In the investigator's opinion, the patient is capable and willing to comply with the requirements of the study;
* Willing and able to sign a written informed consent.
Exclusion Criteria:
* Prior treatment with cancer vaccines;
* Treatment with immunotherapy (e.g., interferons, interleukins, Tumor Necrosis Factor (TNF), or biological response modifiers, such as Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) etc) within four weeks prior to the first vaccination;
* Treatment with immunosuppressive agents (including corticosteroids) within 2 weeks prior to the first vaccination;
* Treatment with any investigational drugs, within 4 weeks prior to the first vaccination;
* Autoimmune or immunodeficiency disease that in the opinion of the investigator may compromise the safety of the patient in the study;
* Any pre-existing medical condition requiring concomitant systemic corticosteroid or immunosuppressive therapy. The use of inhaled corticosteroids for Chronic Obstructive Pulmonary Disease (COPD) or topical steroids is allowed;
* Known hepatitis B and/or C infection documented in patient files, testing not required;
* Known HIV-positivity, testing not required;
* Clinically significant hepatic dysfunction (Alanine amino transferase (ALT)>2.5 times normal upper limits [ULN], Aspartate Amino Transferase (AST)>2.5 times Upper Limit of Normal (ULN), bilirubin>1.5 times ULN);
* Clinically significant renal dysfunction (serum creatinine>1.5 time ULN);
* Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease with unstable angina or myocardial infarction within 6 months before enrolment) or uncontrolled ventricular arrhythmias at the time of enrolment in the study (atrial fibrillation or flutter is acceptable);
* Splenectomy or splenic irradiation;
* Any infectious condition that, in the opinion of the investigator, could compromise the patient's ability to develop an immune response;
* Pregnant or lactating females (female patients of child-bearing potential will undertake pregnancy testing at screening and during study completion/withdrawal visits);
* Alcohol or drug dependence;
* Requirement of concurrent treatment with prohibited medication (investigational product, other anti-cancer treatments including chemotherapy, non-palliative radiotherapy, biological agents and immunomodulating agents, systemic immunosuppressive agents, including systemic corticosteroids);
* The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.
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NCT_ID
NCT02289196
|
Study_NameSafety Study of Vx006 Vaccine in Solid Tumor Patients
| 4,496 |
Study Objectives
This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.
Conditions: Cancer, Malignant Melanoma
Intervention / Treatment:
DRUG: recombinant interleukin-21
Location: Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed surgically incurable metastatic melanoma
* Patients must have measurable disease
* ECOG performance status of 0 or 1
* Expected life expectancy at least 4 months
Exclusion Criteria:
* History of and signs/symptoms of uncontrolled brain metastases or edema.
* Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.)
* Radiotherapy: Radiation therapy within 4 weeks prior to entering the study.
* Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.
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NCT_ID
NCT00336986
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Study_NameEfficacy Study of IL-21 to Treat Metastatic Melanoma
| 4,307 |
Study Objectives
This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen
Conditions: Prostate Cancer
Intervention / Treatment:
BIOLOGICAL: sipuleucel-T
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE
|
Inclusion Criteria:
For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.
* Histologically documented adenocarcinoma of the prostate.
* Metastatic disease.
* Progressive androgen independent castrate resistant prostate cancer.
* Serum PSA >= 5.0 ng/mL.
* Life expectancy of >= 6 months.
* Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
* Men >= 18 years.
* Adequate hematologic, renal and liver function.
Exclusion Criteria:
A subject will not be eligible for participation in this study if any of the following criteria apply.
* The presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
* A requirement for treatment with opioid analgesics for any reason within 21 days prior to registration.
* Moderate to severe disease related pain.
* Eastern Cooperative Oncology Group (ECOG) performance status >= 2.
* Use of non-steroidal antiandrogens within 6 weeks of registration.
* Anti-androgen withdrawal response.
* Treatment with chemotherapy within 3 months of registration.
* More than 2 chemotherapy regimens prior to registration.
* Initiation or discontinuation of bisphosphonate therapy within 28 days prior to registration.
* Treatment with any of the following medications or interventions within 28 days of registration:
* Systemic corticosteroids,
* External beam radiation therapy or surgery,
* Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto,
* Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole,
* 5-alpha-reductase inhibitors,
* High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mcg/day).
* Any other systemic therapy for prostate cancer (except for medical castration).
* Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration.
* Participation in any previous study involving sipuleucel-T, regardless of whether the subject received sipuleucel-T (APC8015) or placebo.
* Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
* A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for >= 3 years at the time of registration.
* A requirement for systemic immunosuppressive therapy for any reason.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or granulocyte-macrophage colony-stimulating factor.
* Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5°F or > 38.1°C) within 1 week prior to registration.
* Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.
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NCT_ID
NCT00715078
|
Study_NameTo Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
| 19,251 |
Study Objectives
To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Paclitaxel/Gemcitabine/Trastuzumab
Location: Korea, Republic of
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 have histologically confirmed and newly diagnosed operable breast cancer
* HER2 positive (all FISH +)
* Axillary node positive (by PET or cytologically determine node by sonography) and/or tumor size > 5 cm -No prior hormonal, chemotherapy or radiotherapy is allowed.
* No breast operation other than biopsy to make diagnosis is allowed.
* Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0 <= age <= 1)
* Adequate hematopoietic function:
Absolute granulocyte count ³1500/mm3,
* platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3
* Adequate renal function: Serum creatinine £ 1.5 mg/dl
* Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ 2 times normal, Alkaline phosphatase: £ 2 times normal-Adequate cardiac function:
1. normal or nonspecific EKG taken within 1 mo of enrollment
2. LVEF ³ 50% by MUGA or Echocardiogram taken within 1 mo of enrollment
* Normal mental function to understand and sign the consent
Exclusion Criteria:
* patients who received hormonal, chemotherapy or radiotherapy for breast cancer
* patients who underwent surgery for breast cancer
* patients with a history of uncompensated congestive heart failure
* Patients with node-negative stage IIA (T2N0) breast cancer
* Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
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NCT_ID
NCT00532857
|
Study_NamePhase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab
| 14,632 |
Study Objectives
This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4.
The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal).
Patients will be recruited over 30 months and followed at least one year after the last patient has been included.
The duration of the treatment period is approximately 20 weeks.
Conditions: Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
Intervention / Treatment:
DRUG: Ofatumumab
Location: Belgium, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.) May also be included : de Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell infiltration in bone marrow
* Or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
* Or CD20+ Follicular lymphoma grade 3B
* Or CD20+ Aggressive B-cell lymphoma unclassifiable Aged > 80 years. Ann Arbor stage I, II, III or IV. All aaIPI Patient non previously treated. All ECOG performance status With a minimum life expectancy of 3 months. Negative HIV, HBV and HCV serologies test < 4 weeks (except after vaccination). Patient able to give his consent and having previously signed a written informed consent.
Patient affiliated to social security system, if applicable
Exclusion Criteria:
Any other histological type of lymphoma, Burkitt included. Any history of treated or non-treated small-B cell lymphoma. Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. Any serious active disease (according to the investigator's decision). Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score <7, and a prostate specific antigen (PSA) <10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) >2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy Adult patient under tutelage.
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NCT_ID
NCT01195714
|
Study_NameStudy of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years
| 8,807 |
Study Objectives
70% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to grow and are likely to respond to hormone treatment. This type of treatment reduces the amount of oestrogen in the body, slowing the growth of cancer or stopping it altogether. One type of hormone treatment, aromatase inhibitors (AIs), works by stopping the body from making oestrogen. Currently, women with locally advanced or metastatic breast cancer that is not being controlled by one class of AI are switched to the other class of AI. The reason for this is that some cancer cells can become resistant to one class but are still sensitive to the other class. However, oestrogen can be made in the body by two pathways and AIs block only one of these pathways. A new drug called Irosustat can reduce the production of oestrogen in the body by blocking the second pathway. This study is investigating whether adding Irosustat to AI treatment i.e. blocking both pathways at the same time, can further reduce the amount of oestrogen in the body and therefore control the breast cancer better.
27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer that is not being controlled by their current AI treatment will be recruited in this study from 9 United Kingdom (UK) hospitals. Eligible patients will receive 40mg of Irosustat once daily in addition to the AI on which they progressed. Patients will receive Irosustat for as long as it controls their cancer or until they have side effects that stop them from taking treatment. Patients will be seen monthly for the first 6 months and every 3 months thereafter. Participating patients will also be given the option to take part in the exploratory part of this study by donating tissue and blood samples.
Conditions: Locally Advanced Breast Cancer, Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Irosustat
Location: United Kingdom
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 prior to admission to this study.
* Aged >= 25 years.
* Histologically confirmed ER+ve primary or metastatic breast cancer.
* Locally advanced or metastatic breast cancer treated with 1st line AI treatment with either a documented objective response (CR/PR) or disease stabilisation (SD) for at least 6 months prior to disease progression.
* Postmenopausal as defined by any of the following criteria:
1. Amenorrhoea for at least 6 months prior to study entry and estradiol and LH/FSH in the postmenopausal range on local laboratory analysis whilst taking a 3rd generation AI during the screening phase of the study.
2. Amenorrhoea during combination treatment with ovarian suppression (e.g. goserelin) and an AI in which case estradiol should be below the limit of detection of the standard local laboratory assay during the screening phase of the study.
* ECOG performance status 0 to 2.
* Measurable and/or evaluable sites of locally advanced or metastatic disease that can be accurately assessed by CT/MRI scan at baseline and follow up visits (RECIST v1.1).
N.B Patients with bone metastasis are eligible provided they have evaluable metastases sites that can be followed (X-Ray or MRI/CT scanning). Patients on established bisphosphonate treatment for at least 3 months are eligible for entry into the trial and are allowed to continue with bisphosphonate treatment.
* Adequate organ function as defined by (Haemoglobin (Hb) >= 9 g/dL; Absolute Neutrophil Count (ANC) >= 1.5 x 109/L; Platelet count (Plts) >= 100 >= 109/L; White Blood Cell (WBC) >= 3.0 x 109/L; Serum albumin <= 1.5 upper limit of normal (ULN); Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <= 3 x ULN if no demonstrable liver metastases or <= 5 x ULN in the presence of liver metastases; alkaline phosphatase (ALP) <= 5 x ULN; Total bilirubin <= 1.5 x ULN if no demonstrable liver metastases or <= 3 x ULN in the presence of liver metastases; Creatinine <= 1.5 x ULN or creatinine clearance >50ml/min).
* Life expectancy of >=3 months.
Exclusion Criteria:
* Human epidermal growth factor Receptor-2 (HER2) positive cancer.
* Discontinuation of current AI therapy for > 21 days prior to study entry.
N.B If the patient has discontinued the AI within this period they can be restarted on the same AI. This must be continued for at least 7 days before introducing the IMP. Baseline investigations must be performed in timeframes related to the start of the IMP, not the AI.
* Rapidly progressive, life-threatening metastases, including any of the following:
1. Patients with active parenchymal brain or leptomeningeal involvement
2. Symptomatic lymphangitis carcinomatosis
3. Extensive visceral metastases requiring chemotherapy.
* Patients with a history of another primary malignancy within 5 years prior to starting study treatment, except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in site and the disease under study.
* More than one prior line of chemotherapy for locally advanced or metastatic disease.
* AI therapy given in combination with another endocrine agent with the exception of a GnRH agonist.
* Radiotherapy to measurable lesion within 2 months of treatment start.
* Systemic corticosteroids for >= 15 days within the last 4 weeks.
* Evidence of uncontrolled active infection.
* Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial.
* Concurrent therapy with any other investigational agent.
* Concomitant use within 14 days prior to commencement of study treatment of:
1. Rifampicin and other CYP2C and 3A inducers such as rifabutin, rifapentine, carbamazepine, phenobarbital, phenytoin and St. John's Wort
2. Systemic carbonic anhydrase inhibitors.
* Any of the following cardiac criteria:
1. Mean resting corrected QT interval (QTcf) >450 ms as calculated by Fridericia's formula obtained from 3 electrocardiograms (ECGs)
2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block
3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years or any concomitant medication known to prolong the QT interval.
* Uncontrolled abnormalities of serum potassium, sodium, calcium (corrected) phosphate or magnesium levels.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated investigational medicinal product (IMP) or previous significant bowel resection that would preclude absorption of Irosustat or the AI.
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NCT_ID
NCT01785992
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Study_NameA Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer.
| 5,421 |
Study Objectives
The purpose of this study is to better understand how to use celecoxib, a popular drug widely used for arthritis, for head and neck cancer patients. Some doctors believe that celecoxib may have helpful effects when used for head and neck cancer. Celecoxib has been shown to prevent some cancers in animals. It has also been used to make standard chemotherapy and radiation work better in both animals and humans. However, all of the previous studies focused on tumors outside the head and neck region. To better understand how to use celecoxib for head and neck cancer patients, doctors at MSKCC are studying the effects of the drug on certain chemicals in the body that are thought to be important for cancer treatment.
This study aims to measure how celecoxib affects those chemicals, which can be found in the tumor, blood, and urine of patients with head and neck cancer. Although celecoxib is already used to treat arthritis, this study will be the first to test the drug in head and neck cancer patients.
Conditions: SQUAMOUS CELL CARCINOMA
Intervention / Treatment:
DRUG: celecoxib
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:
* Untreated squamous cell carcinoma of the oral cavity or oropharynx.
* >= 18 years years of age.
* Understand and sign informed consent.
Exclusion Criteria:
* Any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.
* Breast-feeding, pregnancy or of childbearing potential (including at least two years post menopause) and unable to confirm adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.
* History of esophageal, gastric or duodenal ulceration within 6 weeks of enrollment.
* History of acute or chronic renal disorder (blood creatinine level > 1.5 mg/dL).
* History of acute or chronic hepatic disorder or a significant bleeding disorder.
* History of chronic inflammatory disease (e.g. ulcerative colitis, Crohn's disease,rheumatoid arthritis or pancreatitis).
* History of myocardial infarction, angina, or coronary artery disease within the past 6 months, or active cardiac disease.
* The subject is of New York Heart Association (NYHA) Class 3 or 4 cardiac status.
* Corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.
* NSAID (including celecoxib) or aspirin (> 81 mg/day) use within 1 week of enrollment.
* History of hypersensitivity to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides.
* Currently taking fluconazole or lithium.
* Investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.
* Principal Investigator deems subject to be at high risk for non-compliance.
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NCT_ID
NCT00596219
|
Study_NameMolecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma
| 10,347 |
Study Objectives
The purpose of this study is to determine if a vaccine called pTVG-AR can enhance the participant's immune response against prostate cancer.
Conditions: Prostate Cancer
Intervention / Treatment:
BIOLOGICAL: pTVG-AR, BIOLOGICAL: gm-csf
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Participant must be at least 18 years with a histologic diagnosis of adenocarcinoma of the prostate.
* Participant must have metastatic prostate cancer (clinical stage D1 or D2 disease), with previously documented lymph node, soft tissue and/or bone metastases by radiographic imaging (including CT (or MRI) of abdomen and pelvis and bone scintigraphy). Participants in situations in which there is a reasonable clinical suspicion of a second primary tumor (or other non-prostate cancer reason for radiographic abnormalities) are not eligible unless metastatic disease is histologically confirmed to be prostate cancer.
* Participant must have started androgen deprivation therapy (bilateral orchiectomy versus LHRH agonist, and with or without androgen antagonist) at least one month (4 weeks) prior to enrollment and no more than six months (24 weeks) prior to enrollment. Participant must continue the androgen deprivation therapy throughout the study period, and patients are not permitted to change the type of androgen deprivation therapy (e.g. by adding an androgen antagonist) during the course of investigational therapy.
* Participant must have a serum testosterone < 50 ng/dL demonstrated within 1 month of study entry.
* Participant must either not be a candidate for docetaxel chemotherapy for newly diagnosed metastatic prostate cancer, as determined by their treating oncologist, or have declined this therapy
* Participant must have evidence of response to androgen deprivation as defined by a documented decline in serum PSA values from pre-androgen deprivation treatment baseline and without evidence of PSA progression while on androgen deprivation (defined by PCWG2 criteria as a 25% increase in serum PSA and an absolute increase of 2 ng/mL over nadir).
* Participant with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, or other in situ carcinoma that has been adequately treated.
* Participant who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization.
* Eastern Cooperative Oncology Group (ECOG) performance score < 2.
* Participant must have adequate hematologic, renal and liver function as defined by: WBC > 3000/mm3, hematocrit > 30%, platelet count > 100,000/mm3, serum creatinine < 1.6 mg/dl or a calculated creatinine clearance > 60 cc/min, and serum bilirubin < 2.0 mg/dl, within 4 weeks prior to first immunization.
* Participant must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding.
Exclusion Criteria:
* Small cell or other (non-adenocarcinoma) variant prostate cancer histology.
* Participant cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to >30% of the bone marrow, within 6 months of the first vaccination. Treatment or salvage radiation therapy encompassing < 30% of bone marrow must have been completed 4 weeks prior to the first vaccination.
* Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per participant history.
* Participant previously treated with neoadjuvant and/or adjuvant androgen deprivation (e.g. with radiation therapy) prior to the 6-month eligibility period are allowed, assuming they did not meet criteria for progression (defined by PCWG2 criteria as a 25% increase in serum PSA and an absolute increase of 2 ng/mL over nadir) while on treatment.
* Participant must not be concurrently taking other medications or supplements with known hormonal effects (other than LHRH agonists or non-steroidal anti-androgen), including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto. All other medications with possible anti-cancer effects must be discussed with the Protocol Principal Investigator prior to study entry.
* Participant previously treated with herbal supplements as described in 6.B.5, or other potential or experimental therapies for prostate cancer (apart from LHRH agonists and antiandrogens as described in 6.A.3 above), must have been discontinued these treatments and completed at least a one-month washout prior to first vaccination.
* Participant must not have plans to receive concomitant chemotherapy, other biological or immune therapies, or radiation therapy for the treatment of prostate cancer during the period of study treatment.
* Participant must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.
* Participant must not have known allergic reactions to GM-CSF or the tetanus vaccine.
* Prior treatment with another experimental anti-tumor vaccine is permissible.
* Participant with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Protocol Principal Investigator, excess risk associated with study participation or study agent administration.
* Unable or unwilling to undergo two leukapheresis procedures.
* Participant with medical conditions precluding leukapheresis.
* Participant cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies for the treatment of prostate cancer.
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NCT_ID
NCT02411786
|
Study_NameA Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF
| 7,088 |
Study Objectives
The purpose of this study is to investigate whether the addition of panitumumab to radiotherapy plus gemcitabine will increase the number of patients who are alive and progression free at 7 months.
Conditions: Pancreatic Cancer
Intervention / Treatment:
DRUG: Panitumumab
Location: Netherlands
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:
* Histological or cytological confirmed pancreatic cancer.
* Not eligible for curative resection.
* No distant metastases present.
* Previously untreated with chemotherapy and anti-cancer biologicals for current malignancy.
* No other current malignant disease, except for basal cell carcinoma of the skin.
* Measurable or evaluable disease as defined by RECIST 1.1 criteria.
* Performance status 0 <= age <= 2 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale.
* Age >= 18 years.
* Adequate haematological and biological functions:
* Bone marrow function:
1. Neutrophils >= 1.5 x 109/L
2. Platelets >= 100 x 109/L
3. Hb >= 6 mmol/L
* Hepatic function:
1. AST/ALT and alkaline phosphatase (ALP) <= 2.5 x institutional upper limit of normal (ULN)
2. Bilirubin <= 1.5 times institutional ULN
* Renal function:
eGFR >50ml/min
* Metabolic Function:
* Magnesium >= lower limit of normal
* Calcium >= lower limit of normal.
* No imminent bowel obstruction.
* No active bleeding.
* No uncontrolled infection.
* Patients with reproductive potential must use effective contraception. Female patients must have a negative pregnancy test.
* Signed informed consent.
Exclusion Criteria:
* Participation in another therapeutic clinical study within 30 days of enrollment or during this clinical study.
* No adequate radiation therapy possible: based on the opinion of the radiation oncologist when radiation therapy cannot be performed because radiation field is too large (PTV volume too large or OAR too high)
* History of allergic reactions to gemcitabine or antibody treatment.
* Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection, uncontrolled hypertension).
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 1 year before enrolment/randomization
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
* Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance.
* Pregnant or breastfeeding women.
* Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment.
* Known positive status for HIV and/or hepatitis B or C.
* Any reason why, in the investigator's opinion, the patient should not participate in the study.
* Drug or alcohol abuse.
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NCT_ID
NCT01175733
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Study_NameChemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer
| 21,054 |
Study Objectives
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Erythroleukemia (M6a), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Adult Pure Erythroid Leukemia (M6b), B-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Burkitt Lymphoma, Childhood Acute Erythroleukemia (M6), Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monocytic Leukemia (M5b), Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Juvenile Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Previously Treated Myelodysplastic Syndromes, Prolymphocytic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin 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 Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Secondary Myelofibrosis, Splenic Marginal Zone Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia, T-cell Adult Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia, T-cell Large Granular Lymphocyte Leukemia, Waldenstrom Macroglobulinemia
Intervention / Treatment:
PROCEDURE: double-unit umbilical cord blood transplantation, OTHER: cytogenetic analysis, PROCEDURE: bone marrow aspiration, OTHER: fluorescence in situ hybridization, DRUG: busulfan, DRUG: cyclophosphamide, DRUG: anti-thymocyte globulin, DRUG: methylprednisolone, DRUG: cyclosporine, DRUG: mycophenolate mofetil, OTHER: flow cytometry, PROCEDURE: allogeneic hematopoietic stem cell transplantation
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:
* Patients will be diagnosed with one of the following hematological malignancies: acute myelogenous leukemia (AML), acute lymphoblastic leukemia, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and myeloproliferative and lymphoproliferative disorders
* AML--First remission (CR1) with high risk features including a known prior diagnosis of myelodysplasia (MDS); therapy related AML; white cell count at presentation > 100,000; presence of extramedullary leukemia at diagnosis; unfavorable AML subtype (M0, M5-M7); poor cytogenetic markers (abnormalities of chromosome 5, 7 or 8, 11q23, Philadelphia chromosome, complex karyotype)
* AML--Second remission (CR2) or subsequent remission
* AML--Relapse/Persistent Disease with < 20% bone marrow blasts
* ALL--First remission (CR1) at high risk for relapse as defined by: B cell ALL white blood cell count (WBC) at presentation > 30,000 (T cell ALL WBC > 100,000); presence of high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23), t(8;14)
* ALL--Second remission (CR2) or subsequent remission
* ALL--Relapse/Persistent Disease with < 20% bone marrow blasts
* Non-Hodgkin Lymphoma--Induction failure or relapse and sensitive to most recent chemotherapy
* MDS--Low or Intermediate-1 International Prognostic Scoring System (IPSS) score with: life-threatening cytopenia(s); and/or red cell or platelet transfusion dependence
* MDS--ANC < 500, recurrent infections, PRBC transfusions > 2 units/month, poor risk cytogenetics, platelet transfusion dependence
* MDS--Intermediate-2 or High IPSS score
* CML--Chronic phase I (CP1) and resistant to or intolerant of tyrosine kinase inhibitors (i.e. imatinib, dasatinib, etc.)
* CML--CP2 or subsequent chronic phase, including chronic phase achieved after induction therapy for blast crisis
* Myeloproliferative and lymphoproliferative disorders--eligibility to be determined by a consensus of the physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee
* Myeloproliferative and lymphoproliferative disorders--must have evidence of disease acceleration to be a candidate for umbilical cord blood transplant; myeloproliferative disorders eligible for transplant include chronic myelomonocytic leukemia (CMML) with high IPSS score and myelofibrosis
* Myeloproliferative and lymphoproliferative disorders--potential lymphoproliferative disorders eligible for transplant include chronic lymphocytic leukemia, prolymphocytic leukemia, and large granular lymphocytic leukemia
* Good performance status: Karnofsky >= 70 % or ECOG 0 <= age <= 1
* Calculated creatinine clearance >= 60 mL/min, or measured creatinine clearance >= 60 mL/min (by 24-hour urine collection) if creatinine >= 1.5 or history of renal dysfunction
* Hepatic Transaminases < 4 x upper limit normal (ULN); total bilirubin < 2.5 mg/dL, unless the patient has a history of benign congenital hyperbilirubinemia (Gilbert's syndrome)
* Normal cardiac function by echocardiogram or radionuclide scan, (left ventricular ejection fraction > 45%); if the left ventricular ejection fraction is between 40 <= age <= 50%, clearance by an adult cardiologist is required
* Pulmonary function tests demonstrating FEV1 > 60% of predicted for age
* Adults must have a DLCOva > 60% normal
* For patients unable to complete pulmonary function tests clearance by an adult pulmonologist is required
* Patients will be eligible for the clinical trial under the following conditions: they do NOT have an HLA-A/B/DR B1 identical RELATED bone marrow donor; they do NOT have a 6/6 HLA-identical matched unrelated adult donor; OR a matched related donor transplant is not in the best interest of the patient (i.e., patient's condition precludes waiting on the donor, too much time to prepare the donor, the donor is ineligible due to medical reasons, or in the case of high risk disease a related donor is not appropriated (syngeneic transplant); the decision must be agreed upon by the consensus of physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee; OR their condition precludes waiting to search and find a donor in the National Marrow Donor Registry
Exclusion Criteria:
* Female patients who are pregnant or breast-feeding
* HIV or HTLV-1 positivity
* Any leukemia with a morphologic relapse or persistent disease in the BM with >= 20% blasts (cytogenetic relapse without morphologic evidence of relapse, or cytogenetic persistent disease is acceptable)
* Active extramedullary leukemia, including CNS disease
* Prior hematopoietic stem cell transplant (autologous or allogeneic)
* Uncontrolled infection
* Patient has an identical related bone marrow donor or a 6/6 HLA-identical matched unrelated donor
* Any patient who is unable to provide informed consent or comply with the requirements of the protocol
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NCT_ID
NCT01093586
|
Study_NameDonor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
| 4,168 |
Study Objectives
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. 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. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with combination chemotherapy may kill more tumor cells.
Conditions: Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Metastatic Childhood Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Untreated Childhood Rhabdomyosarcoma
Intervention / Treatment:
BIOLOGICAL: Cixutumumab, DRUG: Cyclophosphamide, BIOLOGICAL: Dactinomycin, DRUG: Doxorubicin Hydrochloride, DRUG: Etoposide, DRUG: Ifosfamide, DRUG: Irinotecan Hydrochloride, OTHER: Laboratory Biomarker Analysis, DRUG: Temozolomide, DRUG: Vincristine Sulfate Liposome
Location: Canada, New Zealand, United States, Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients must be eligible for, and enrolled on D9902 prior to enrollment on ARST08P1
* Patients with newly diagnosed, biopsy-proven metastatic rhabdomyosarcoma or ectomesenchymoma (stage IV, clinical group IV) are eligible for this study; patients with stage IV, clinical group IV RMS with parameningeal and paraspinal primary tumors, including those with intracranial extension (ICE) are eligible for ARST08P1; ICE is defined by contrast magnetic resonance imaging (MRI) showing that the primary tumor touches, displaces, invades, distorts, or otherwise causes signal abnormality of the dura in brain or spinal cord in contiguity to the primary site; ICE is also presumed to exist if the cerebrospinal fluid (CSF) cytopathology is positive for tumor at diagnosis
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years and Lansky for patients =< 16 years
* No prior chemotherapy or radiotherapy except for use of corticosteroids or emergent radiation therapy; patients requiring emergency radiation are eligible
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73m^2 OR maximum serum creatinine based on age/gender as follows:
* 0.4 mg/dL (for patients 1 to 5 months of age)
* 0.5 mg/dL (for patients 6 to 11 months of age)
* 0.6 mg/dL (for patients 1 year of age)
* 0.8 mg/dL (for patients 2 <= age <= 5 of age)
* 1.0 mg/dL (for patients 6 <= age <= 9 of age)
* 1.2 mg/dL (for patients 10 <= age <= 12 of age)
* 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 <= age <= 15 of age)
* 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients >= 16 years)
* Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract
* Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, unless there is evidence of biliary obstruction by the tumor
* Shortening fraction >= 27% by echocardiogram (ECHO) OR ejection fraction >= 50% by radionuclide angiogram
* Absolute neutrophil count (ANC) >= 750/uL; abnormal blood counts are permissible if there is bone marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma
* Platelet count >= 75,000/uL; abnormal blood counts are permissible if there is bone marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma
* Sexually active patients of childbearing potential must agree to use effective contraception during therapy (Pilots 1 and 2) and for at least 3 months after the last dose of IMC-A12 (Pilots 1)
Exclusion Criteria:
* Female patients who are pregnant are not eligible
* Female patients who are breastfeeding are not eligible; female patients who are lactating must agree to stop breastfeeding to participate in this study
* Patients receiving growth hormone therapy are not eligible
* Patients with known type I or type II diabetes mellitus are not eligible for enrollment on Pilot 1
* Patients with evidence of uncontrolled infection are not eligible
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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NCT_ID
NCT01055314
|
Study_NameTemozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
| 13,369 |
Study Objectives
This is a Phase 1 trial of TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592). TLX592 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours, therefore this study has been designed to assess the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of 64Cu-TLX592.
Conditions: Metastatic Prostate Cancer
Intervention / Treatment:
DRUG: 64Cu-DOTA-TLX592
Location: Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Written informed consent.
* Biochemically recurrent metastatic adenocarcinoma of the prostate, or metastatic primary adenocarcinoma of the prostate.
* Histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
* PSMA-expressing prostate adenocarcinoma as seen on 68Ga-PSMA-11 or 18F- DCFPyl PSMA PET/CT scanning within the last 1 month showing PSMA-avid disease.
* ECOG performance status of 0 - 1.
* Normal organ function and marrow reserve:
* White blood cell (WBC) count >= 2.5 x 109/L or absolute neutrophil count (ANC) >= 1.5 x 109/L.
* Platelets >= 100 x 109/L.
* Haemoglobin >= 90g/L.
* Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5 - 2x ULN, must have a normal conjugated bilirubin).
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <= 2.0 x ULN (or
* 5.0 x ULN in the presence of liver metastases).
* Serum creatinine <= 1.5 x ULN or creatinine clearance >= 60 mL/min.
Exclusion Criteria:
A patient is excluded from participation in the trial if one or more of the following criteria are met:
* Known active brain metastases.
* Serious active infection (as assessed by investigator).
* Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or haematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
* Known or suspected allergies, hypersensitivity, or intolerance to the IMP or its excipients.
* Other investigational agents within 4 weeks of randomization.
* Radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 64Cu-TLX592 or continuing adverse effects (> grade 1) from such therapy [Common Terminology Criteria for Adverse Events (CTCAE) version 5].
* Previous administration of any radionucleotide within 10 half-lives of 64Cu.
* Inability to understand, or unwilling to sign, a written informed consent document or to follow investigational procedures in the opinion of the investigator.
* Patients who are unable to maintain self-care.
|
NCT_ID
NCT04726033
|
Study_Name64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)
| 20,336 |
Study Objectives
This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.
Conditions: Peripheral T Cell Lymphoma
Intervention / Treatment:
DRUG: CHOP21, DRUG: VIP/ABVD, RADIATION: Radiotherapy consolidation
Location: France
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:
* newly diagnosed untreated PTCL
* age 18 and 70 years
* performance status <= 2
* Ann Arbor stage I to IV
* normal cardiac ventricular ejection fraction over 50%
* normal hepatic function (asat, ALAT, PAL < 2.5 ULN)
Exclusion Criteria:
* cutaneous form of PTCL
* previous treatment
* age < 18 and > 70
* performance status > 2
* abnormal cardiac or hepatic functions
* HIV-, HCV- or HBV- positivity
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NCT_ID
NCT00970385
|
Study_NameStudy About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma
| 18,970 |
Study Objectives
The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: Oxaliplatin Based Chemotherapy, DRUG: Panitumumab, DRUG: Irinotecan Based Chemotherapy, DRUG: Bevacizumab
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Adenocarcinoma of the colon or rectum
* Metastatic colorectal cancer (mCRC)
* Measurable disease per modified response evaluation criteria in solid tumors (RECIST) criteria
* ECOG performance status of 0 or 1
* Available paraffin-embedded tumor tissue (from primary tumor or metastasis) or unstained slides of paraffin-embedded tissue
* If history of other primary cancer, subject will be eligible only if she or he has:
* Curatively resected non-melanomatous skin cancer;
* Curatively treated cervical carcinoma in situ;
* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 5 years.
* Adequate hematologic data as follows:
* Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9 cells/L;
* Platelet count greater than or equal to 100 x 10^9/L;
* Hemoglobin greater than or equal to 9.0 g/dL. - Adequate renal function:
* Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN);
* Urinary protein dipstick of less than 2+ (if urinary dipstick 2+ or greater, then excretion of less than or equal to 1000 mg of protein per day as determined by 24-hour urine collection).
* Adequate hepatic function:
* Alkaline phosphatase less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
* Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)(AST) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
* Alanine aminotransferase (serum glutamic-pyruvic transaminase) (ALT) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
* Bilirubin less than or equal to 2 x ULN. - Competent to comprehend, sign, and date an IRB-approved informed consent form
* Before any study-specific procedure, the appropriate written informed consent must be obtained.
Exclusion Criteria:
* Prior chemotherapy or biologic (i.e., antibody or vaccine) treatment for mCRC disease - Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before randomization - Radiotherapy within 14 days before randomization
* Elective and/or planned major surgical procedure to be performed during the course of this trial (surgery that arises as needed or necessary during the course of the study, not agreed a priori, will not make the subject ineligible)
* Major surgery within 28 days before randomization
* Central nervous system metastases
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or CT-scan
* Clinically significant ascites
* Preexisting bleeding diathesis or coagulopathy or the need for full-dose anticoagulation
* Any of the following within 1 year before randomization:
* Myocardial infarction;
* Unstable angina;
* Symptomatic congestive heart failure;
* Serious uncontrolled cardiac arrhythmia;
* Cerebrovascular accident or transient ischemic attack;
* Gastrointestinal ulcer or hemorrhage;
* Hemoptysis;
* Pulmonary embolism;
* Deep vein thrombosis, or other significant thromboembolic event.
* Regular use of non-steroidal anti-inflammatory agents
* Female subject of childbearing potential, not abstinent, and not willing to use contraceptives during the course of the study and for 6 months following the last dose of first-line treatment
* Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization
* Male subject, not abstinent, and not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of first-line treatment
* Subject known to be human immunodeficiency virus (HIV) positive
* Subject allergic to panitumumab or any components of panitumumab formulation
* History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
* Subject unwilling or unable to comply with study requirements
* Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
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NCT_ID
NCT00115765
|
Study_NamePACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
| 2,078 |
Study Objectives
This study aims to evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer.
Conditions: Invasive Bladder Cancer Stage II
Intervention / Treatment:
DRUG: Rapamycin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Have invasive (>=T1) bladder cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* In their treating physician's opinion is a good candidate for radical cystectomy
* In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy
* Be able to give informed consent
* Be age >= 18 years
* Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3 hemoglobin >9.5 gm/dl or platelets more than 100,000 cells/mm3).
* Have adequate end-organ function (GFR >30, bilirubin <1.5, SGOT < 3x ULN)
* Have a life expectancy > one year
* Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment
* Not have received chemotherapy or radiotherapy in the prior 30 days
Exclusion Criteria:
* Immunosuppressed state (e.g. HIV, use of chronic steroids)
* Fixed disease (clinical T4)
* Active, uncontrolled infections
* Hepatic impairment (SGOT >3x ULN)
* Unhealed wounds
* Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
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NCT_ID
NCT01827618
|
Study_NameNeoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
| 7,780 |
Study Objectives
This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple myeloma.
Conditions: Advanced Solid Tumors, Multiple Myeloma
Intervention / Treatment:
DRUG: ONC-201
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:
* Solid tumor specific:
* Patients must have a histologically/cytologically confirmed primary solid tumor
* Radiographic or clinical evidence of advanced/metastatic malignant disease that is resistant to standard therapy or for which no standard therapy is available. Lesions may be measurable or non-measurable
* Multiple myeloma specific:
* Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment
* Measurable disease M protein component in serum (at least 0.5 g/dL) and/or urine (if present), (>=0.2 g excreted in a 24 hour collection sample).
* Subjects with free light chain only disease are excluded
* All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for >= 14 days (>= 28 days for mitomycin C or nitrosoureas ) before Cycle 1 Day 1 (C1D1), and all acute effects of any prior therapy resolved to baseline severity or Grade <= 1 Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia or parameters defined in this eligibility list
* Age >= 18 years
* ECOG performance status <= 1
* Adequate organ and marrow function as defined below:
* Absolute neutrophil count >=1,000/mm3 without growth factor use <= 7 days prior to C1D1
* Platelets >=75,000/mm3 without platelet transfusion <= 7 days prior to C1D1
* Hemoglobin >8.0 mg/dL without red blood cell transfusion <= 7 days prior to C1D1
* Total serum bilirubin <1.5 X upper limit of normal (ULN)
* AST (SGOT)/ALT (SGPT) <=2 X ULN; <= 5 X ULN if there is liver involvement secondary to tumor
* Serum creatinine <= 1.5 X ULN (OR creatinine clearance >= 60 mL/min/1.73 m2)
* Serum or urine pregnancy test (for females of childbearing potential) negative <=7 days of starting treatment
* Ability to understand and the willingness to sign a written informed consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
* Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.
Exclusion Criteria:
* Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases > 28 days prior to study entry including radiotherapy or surgery. Steroids for the treatment of brain metastasis are not permitted.
* Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
* Pregnancy or breast feeding
* Current active treatment in another clinical study
* Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), requiring treatment with IV antibiotic, IV anti-fungal, or anti-viral.
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
* Multiple myeloma specific:
* Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10^9/L)
* Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
* Subjects with serum calcium (corrected for albumin) >= 12 mg/dL
* Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
* Other severe acute or chronic medical or psychiatric condition 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, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
|
NCT_ID
NCT02609230
|
Study_NameA Dose-Escalation Study of Onc201 Administered Every One or Three Weeks in Advanced Solid Tumors and Multiple Myeloma
| 3,882 |
Study Objectives
This is a research study for newly diagnosed multiple myeloma or multiple myeloma has returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells called plasma cells. Plasma cells make proteins that help fight infections. Current therapy for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells) stem cell transplantation.
There will be two parts (or phases) to this study:
The purpose of the first part is to find the highest dose of a drug called lenalidomide (Revlimid®) that can be given in combination with high dose melphalan without causing severe adverse events.
The purpose of the second part is to find out the effects of this treatment (good and bad) on multiple myeloma patients.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Lenalidomide plus Melphalan during autologous stem cell transplantation, DRUG: Lenalidomide maintenance
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Interventional Model: SEQUENTIAL
Masking: NONE
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Inclusion Criteria:
* Phase I: Patients with diagnosis of multiple myeloma at any stage of disease undergoing high dose chemotherapy and stem cell transplantation.
* Phase II: Patients with myeloma undergoing a first high dose chemotherapy and stem cell transplantation after achieving at least stable disease following induction therapy. Any induction regimen prior to transplantation is allowed. No more than 2 prior lines of therapy prior to transplantation are allowed.
* All previous therapy not associated with peripheral blood stem cell transplant, including radiation, hormonal therapy, and surgery, must have been discontinued 4 weeks prior to treatment in this study.
* ECOG performance status of <= 2 at study entry
* Laboratory test results within protocol-specified ranges
* 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 must have negative pregnancy test within 24 hours of first prescription for lenalidomide and must commit to either continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
* Able to take aspirin daily as prophylactic anticoagulation
* Subject must have the minimum stem cell dose of 5.0 x 10^6 CD34+ cells/kg collected.
Exclusion Criteria:
* Pregnant or breast feeding females
* History of intolerance or resistance to lenalidomide
* Known hypersensitivity to thalidomide
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Known seropositive for or active viral infection with human immunodeficiency vrus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis b virus vaccine are eligible.
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NCT_ID
NCT01142232
|
Study_NameLenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma
| 15,409 |
Study Objectives
This study is a open-label, phase I, dose escalation clinical study to evaluate the safety and tolerability of HLX26 and HLX10 in the treatment of patients with advanced/metastatic solid tumors.
Conditions: Adult Solid Tumor
Intervention / Treatment:
DRUG: HLX26, DRUG: HLX10
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
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Inclusion Criteria:
* Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
* Aged >= 18 years and <=75 years at the time of signing the ICF;
* Patients with histologically or cytologically confirmed advanced malignant solid tumor who have failed or cannot receive the standard treatment;
* With at least one measurable lesion according to RECIST V1.1 (for solid tumors);
* Eastern Cooperative Oncology Group (ECOG) performance status score of <= 1 at enrollment;
* Expected survival > 3 months;
* Patients with Non-Small Cell Lung Cancer had no EGFR sensitivity mutation or gene rearrangement or jump of ALK, ROS1, RET and METex14;
* For patients with hepatocellular carcinoma, Child-Pugh score has to be A;
* Have appropriate hematological functions: no blood transfusion or Treatment for hemocytopenia within 14 days before the first administration; absolute neutrophil count >= 1500/μL; haemoglobin >= 9 g/dL; platelet count >= 90,000/μL;
* Have appropriate coagulation functions: activated partial thromboplastin time (APTT) <= 1.5 × ULN; prothrombin time (PT) <= 1.5 × ULN; international normalized ratio (INR) <= 1.5 × ULN;
* Have appropriate liver functions: total bilirubin level <= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 × ULN (AST and ALT <= 5 × ULN for patients with known liver metastasis or primary hepatocellular carcinoma);
* Have appropriate renal functions: blood creatinine <= 1.5 × ULN or creatinine clearance >= 50 mL/min (calculated by Cockcroft-Gault formula);
* The first administration of the investigational product must be: at least 28 days apart from the previous major surgery, medical device treatment, or local radiotherapy; at least 28 days apart from the previous cytotoxic chemotherapy, immunotherapy, and biological agent therapy; at least 14 days apart from the previous hormone therapy and surgical operation; at least 21 days or 5 half-lives apart from the administration of small molecule targeted drugs, whichever is longer; at least 14 days apart from the traditional Chinese medicine for tumor indications; at least 14 days apart from the endocrine therapy; For any drug with antitumor effect not listed above, at least 5 half lives shall be separated before administration of the first study drug;
* Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last administration of the investigational product.
Exclusion Criteria:
* The adverse reactions (except alopecia and other adverse reactions determined by the investigator to have no safety risk) of previous anti-tumor therapy have not yet recovered to <= grade 1 (CTCAE V5.0);
* Those who are known to have severe anaphylaxis (grade 4 or greater in CTCAE V5.0) to macromolecular protein preparations/monoclonal antibodies or to any component of the investigational product;
* Patients with any of the following unstable or poorly controlled diseases:1)Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks before the first administration of the investigational product;2)Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater cardiac failure or left ventricular ejection fraction (LVEF) < 50%; (2) unstable angina pectoris; (3) myocardial infarction and cerebral infarction within 6 months, (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or poorly controlled after clinical intervention;3)Other chronic diseases which, in the opinion of the investigator, may compromise the safety of the patient or the integrity of the study;
* Assessed as unsuitable for inclusion by the investigator, due to brain metastases, spinal cord compression, or cancerous meningitis with clinical symptoms, or uncontrolled brain or spinal cord metastases that have been evidenced;
* Previous grade 3 or greater irAEs in immunotherapy;
* Have had other malignant tumors within 5 years before enrollment, except: (a) those with cured cervical carcinoma in situ or non-melanoma skin cancer; (b) those with cured second primary cancer without recurrence within 5 years; (c) those with double primary cancers believed to be able to benefit from this study; (d) those whose metastasis has been clearly excluded from a certain primary tumor source;
* those who have received anti-LAG-3 antibody therapy;
* Have active autoimmune diseases (including but not limited to the following diseases or syndromes, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism), except: vitiligo or cured childhood asthma/allergy that does not need any intervention in adulthood, autoimmune mediated hypothyroidism treated with stable dose of thyroid replacement hormone, and type I diabetes treated with stable dose of insulin; those in a stable condition and requiring no systemic immunosuppressant therapy (including corticosteroid hormone) are allowed to be enrolled;
* Have received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 14 days before the first administration; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; those with short term use of corticosteroids for prophylaxis, such as contrast agents;
* Patients in pregnancy [confirmed by serum beta-human chorionic gonadotropin (ß-HCG) test] or breastfeeding;
* With a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;
* Patients with active HBV or HCV infection (HBV DNA >= 10*4 copies/mL or positive HCV RNA, but patients with HBV DNA < 10*4 copies / mL after treatment will be excluded); Subjects with co-infection of hepatitis B and hepatitis C (HBsAg or HBcAb positive, and HCV antibody positive);
* Have received live vaccines within 28 days prior to the first administration;
* Interstitial pneumonia occurred during previous anti-tumor treatment;
* Patients whose medical history or any other evidence suggests that participation in the study may confuse the results, or subjects for whom the investigator believes the study is not in their best interest;
* Participating in other clinical studies or less than 14 days from the end of the treatment of the previous clinical study.
|
NCT_ID
NCT05400265
|
Study_NameEvaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor
| 2,183 |
Study Objectives
This is a global, multi-centre, long-term, prospective, observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated for the first time with pazopanib. The study is designed to enroll approximately 700-1000 patients in over the course of an enrollment period of approximately 18 months.There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 30 months or until premature discontinuation (i.e., due to death, withdrawal of consent, lost to follow-up or study termination).
Conditions: Carcinoma, Renal Cell
Intervention / Treatment:
DRUG: Pazopanib
Location: Israel, Germany, Lebanon, United States, Spain, Estonia, United Kingdom, Italy, Pakistan, Taiwan, Austria, Belgium, Greece, Turkey, Colombia, Finland, Hungary, Argentina
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Patients eligible for enrolment in the study must meet all of the following criteria:
* Age >= 18 years at enrollment
* Documented diagnosis of advanced and/or metastatic clear cell or predominantly clear cell RCC
* Clinical decision made to initiate treatment with pazopanib prior to enrollment in the study, but within 30 days of enrollment
* Willing and able to provide written informed consent
Exclusion Criteria:
* Patients meeting any of the following criteria must not be enrolled in the study:
* Patients currently participating in any interventional clinical trials in which treatment regimen and/or monitoring is dictated by a protocol
* Previous exposure to an investigational or licensed multi-kinase inhibitor or an anti- VEGF angiogenesis inhibitor for advanced or metastatic disease
* Life expectancy < 12 weeks
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NCT_ID
NCT01649778
|
Study_NameObservational Study of Real World Effectiveness Data and Safety in Patients Receiving Pazopanib With Advanced or Metastatic Renal Cell Carcinoma
| 17,907 |
Study Objectives
The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: E7070
Location: France, United Kingdom
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:
* Ambulant male or female patients with metastatic colorectal cancer who have been previously treated with 5-fluorouracil/leucovorin and oxaliplatin. Patients must fulfill the following criteria to be included in the study:
* At least 4 doses of previous treatment with oxaliplatin
* All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved
* At least one uni-dimensionally measurable lesion according to RECIST criteria (the following do not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions)
* Aged greater than or equal to 18 years
* Histologically or cytologically confirmed colorectal cancer
* Karnofsky performance status greater than or equal to 70%
* Written informed consent to participate in the study
Exclusion criteria:
Patients with the following characteristics will not be included in the study:
* More than three previous lines of chemotherapy (including neo-adjuvant and adjuvant)
* Prior treatment with cytotoxics other than 5- fluorouracil/leucovorin (capecitabine and UFT are permitted) and oxaliplatin. Prior epidermal growth factor receptor targeted and anti-angiogenic therapy is permitted.
* Untreated brain metastases (patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 4 weeks prior to entry). Patients must not have clinical symptoms from brain metastases and must not be taking corticosteroids for the treatment of brain metastases. Patients must not have leptomeningeal metastases
* Any of the following laboratory parameters:
1. hemoglobin <10 g/dl;
2. neutrophils <1.5 x 109/L;
3. platelets <100 x 109/L;
4. serum bilirubin >25 mmol/l (1.5 mg/dl);
5. other liver parameters >2.5 x upper normal limit (ULN) (> 5 x upper normal limit in the presence of hepatic metastases);
6. serum creatinine >1.5 x ULN;
7. serum calcium (corrected for albumin) >=11.5 mg/dl. 5. History of Gilbert's Disease or conjugated hyperbilirubinemia 6. Concurrent or previous malignancy of a different tumor type within five years of starting the study except for adequately treated non- melanoma skin cancer or cervical intraepithelial neoplasia
* Uncontrolled infections
* Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
* Chronic inflammatory bowel disease and/or bowel obstruction
* History of hypersensitivity to sulfonamides
* History of severe hypersensitivity reactions to one of the excipients of irinotecan
* Treatment within two weeks before the start of the stud y with any of the following: coumarin anti-coagulants, terfenadine, cisapride, cyclosporin, tacrolimus, theophylline, diazepam, sulphonylurea hypoglycaemics, phenytoin, or carbamazepine
* Any treatment with investigational drugs within 30 days before the start of the study
* Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients must use adequate contraceptive protection
* Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection
* History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance.
* Legal incapacity
|
NCT_ID
NCT00165867
|
Study_NameAn Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin
| 9,622 |
Study Objectives
The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your glioblastoma multiforme.
Conditions: Glioblastoma
Intervention / Treatment:
DRUG: PX-866
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies.
* All patients must have formalin fixed paraffin embedded tissue available for translational studies.
* Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be >= 1.0 cm). Baseline CT or MRI must be done within 14 days prior to registration.
* ECOG performance of 0, 1 or 2.
* Age >= 18 years. Previous Therapy
Chemotherapy:
Patients may have received prior adjuvant chemotherapy and/or concurrent chemoradiation as part of primary therapy, but must have received no therapy for recurrent/ progressive GBM (i.e. PX-866 must be first treatment for recurrence/ progression). A minimum of 28 days since the last dose of chemotherapy must have elapsed prior to registration.
Targeted Therapy:
No prior therapy with a phosphatidylinositol 3-kinase (PI-3K) inhibitor. Other targeted agents are permissible provided they were given as part of front line treatment. A minimum of 56 days (8 weeks) must have elapsed since last day for anti-angiogenic therapy and minimum of 28 days for other targeted agents.
Radiation:
Patients may have had prior radiation therapy provided at least 28 days have elapsed from the day of the last fraction of radiation to the date of registration.
* Previous Surgery: Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed prior to registration.
*1.7 Laboratory Requirements (must be done within 7 days prior to registration)
Hematology:
Granulocytes (AGC) >= 1.5 x 109/L Platelets >= 100 x 109/L
Chemistry:
Serum creatinine <= 1.5 x UNL Total bilirubin <= 1.5 x UNL ALT and AST <= 1.5 x UNL Glucose <= 8.9 mmol/L (<= Grade 1)
* Women must be post menopausal, surgically sterile or use a reliable form of contraception while on study and for 30 days after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration and must not be lactating.
* Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is provided. A copy of the initial full board REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to registration (exception for translations). Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
* Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
* In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration.
Exclusion Criteria:
* Patients who have other active malignancies (i.e. documented by imaging, clinical exam or marker) are to be excluded. (Please call NCIC CTG if any questions about the interpretation of this criterion).
* Known HIV-positive patients.
* Uncontrolled diabetes mellitus.
* Patients should be on a stable dose of steroid (i.e. no change in dose for 2 weeks prior to registration) when entered on study. Patients recently started on steroids or whose steroid dose was increased in the recent past should not be started on protocol treatment until at least 2 weeks have passed from the time of steroid dose increment or initiation. Under these circumstances, baseline CT or MRI scan for purposes of assessment of response to protocol treatment should be done at the time of initiation of protocol therapy (i.e., these patients must be re-imaged to control for steroid effects).
Note:
The idea behind this is to restrict entry to a subset of patients who are not rapidly changing: especially rapidly deteriorating. If a patient being worked up for the trial appears to need to have steroid introduced or increased, the patient should be treated as is medically appropriate (i.e., have the steroid introduced or increased). Steroid should NOT be withheld if clinically indicated just so that patients can be registered on study!
* Patients with upper gastrointestinal or other conditions that would preclude compliance or absorption of oral medication are not eligible.
* Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
* Patients are not eligible if they have a known hypersensitivity to the study drugs or their components.
* Patients who have had prior treatment with a PI3 kinase inhibitor.
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NCT_ID
NCT01259869
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Study_NameA Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression
| 11,135 |
Study Objectives
This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
Conditions: Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, DRUG: Leucovorin Calcium, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, DRUG: Prednisone, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine Sulfate
Location: United States, Australia, Canada, New Zealand, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Must be eligible for and enrolled on classification study COG-AALL03B1
* Newly diagnosed B-precursor acute lymphoblastic leukemia
* WBC > 50,000/mm^3 for patients age 1 to 9
* Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease
* Whit blood cell (WBC) criteria:
* Age 1 - 9 years: WBC >= 50,000/uL
* Age 10 - 30 years: any WBC
* Prior steroid therapy: any WBC
* Testicular disease: any WBC
* Patients shall have had no other prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
* Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with Down syndrome are ineligible to enroll onto this study
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NCT_ID
NCT00075725
|
Study_NameDexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
| 2,522 |
Study Objectives
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.
Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.
Conditions: Colorectal Cancer, Colorectal Carcinoma, Liver Metastases
Intervention / Treatment:
DEVICE: SIR-Spheres yttrium-90 microspheres, DRUG: Systemic chemotherapy (FOLFOX)
Location: Israel, Germany, Poland, United States, Spain, Australia, Italy, Belgium, France, New Zealand, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation.
* Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm).
* Suitable for either treatment regimen.
* Prior chemotherapy for metastatic colorectal cancer is not allowed.
* WHO performance status 0 <= age <= 1.
* Adequate hematological, renal and hepatic function.
* Age >= 18 years.
* Willing and able to provide written informed consent.
* Life expectancy of at least 3 months without any active treatment.
Exclusion Criteria
* Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
* Previous radiotherapy delivered to the upper abdomen.
* Non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
* Peripheral neuropathy > grade 1 (NCI-CTC).
* Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
* Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
* Pregnant or breast-feeding.
* Other active malignancy.
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NCT_ID
NCT00724503
|
Study_NameFOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
| 17,108 |
Study Objectives
The purpose of this study is to evaluate the safety and pharmacokinetics and assess the immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).
Conditions: Carcinoma, Renal Cell, Renal Cell Carcinoma of Papillary Histology, Renal Cell Carcinoma With Clear Cell Histology, Renal Cell Carcinoma With Non-Clear Cell Histology
Intervention / Treatment:
DRUG: AGS-16C3F
Location: Canada, 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:
* Dose determination cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or non-clear histology.
* Tumors with clear cell histology: subject must have progressed after at least one anti-vascular endothelial growth factor receptor (anti-VEGFR) therapy
* Tumors with non-clear cell histology must be ectonucleotide pyrophosphatase/phosphodiesterase family member 3 (ENPP3) positive at pre-screening. This sub-group does not have any prior therapy requirement.
* Dose expansion cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or papillary histology
* Tumors with clear cell histology: subject must have progressed after at least one anti-VEGFR therapy
* Tumors with papillary histology: includes unclassified histology with papillary features and must be ENPP3 positive at pre-screening. This sub-group does not have any prior therapy requirement.
* Measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
* Eastern Cooperative Group (ECOG) performance status of 0 <= age <= 1
* Hematologic function, as follows:
* Absolute neutrophil count (ANC) >= 1.5 x 109/L
* Platelet count >= 100 x 109/L
* Hemoglobin >= 9 g/dL (transfusions are allowed)
* Renal function, as follows:
* creatinine <= 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) > 50 mL/min if creatinine > 1.5x ULN
* Hepatic function, as follows:
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 x ULN or <= 5x ULN if known liver metastases
* Total bilirubin <=1.5 x ULN
* International normalized ratio (INR) < 1.3 (or <= 3.0 if on therapeutic anticoagulation)
* Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for 4 weeks after the last AGS-16C3F infusion administration
Exclusion Criteria:
* Current uncontrolled central nervous system (CNS) metastasis or malignant brain tumors
* Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved or returned to baseline
* Known sensitivity to any of the ingredients of the investigational product AGS-16C3F
* History of thromboembolic events and bleeding disorders <=3 months (e.g., (deep vein thrombosis) DVT or pulmonary embolism (PE))
* Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by outpatient medication.
* Major surgery within 4 weeks of study enrollment
* Women who are pregnant (confirmed by positive pregnancy test) or lactating
* Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen.
* Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening.
* History of eye surgery within 6 months, presence of cataracts or other ocular disorders significantly affecting vision
|
NCT_ID
NCT01672775
|
Study_NameA Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary Histology
| 11,955 |
Study Objectives
The SABR-ATAC trial (Stereotactic Ablative Radiotherapy and anti-TGFB Antibody Combination) is a phase I/II trial that studies the side effects and efficacy of fresolimumab, an anti-transforming growth factor beta (TGFB) antibody, when given with stereotactic ablative radiotherapy in patients with stage IA-IB non-small cell lung cancer. Fresolimumab may inhibit radiation side effects and block tumor growth through multiple mechanisms. Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiotherapy (SBRT), is a specialized form of radiation therapy that precisely delivers high dose radiation directly to tumors, thus killing tumor cells and minimizing damage to normal tissue. Giving fresolimumab with SABR may work better in treating patients with early stage non-small cell lung cancer than treating with SABR alone.
Conditions: Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma
Intervention / Treatment:
BIOLOGICAL: Fresolimumab, RADIATION: Stereotactic Body Radiation Therapy
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:
* Newly diagnosed, histologically proven (or strongly suspected, see below) T1-T2aN0M0 (Stage IA-IB) non-small cell lung cancer (NSCLC), with maximum tumor diameter =< 5 cm under consideration for stereotactic ablative body radiotherapy (SABR) as definitive primary treatment
* Patient judged to be inoperable or at high surgical risk by a board qualified thoracic cancer surgeon who has evaluated the subject within the prior 12 weeks, or the patient's case has been discussed at a multidisciplinary tumor board with a thoracic cancer surgeon in attendance, or a patient who refuses surgery or declines to be evaluated for surgery.
* Able to give informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
* Men or women of child bearing potential must agree to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for at least 90 days after last study treatment (radiation or fresolimumab)
Exclusion Criteria:
* Significant anemia (hemoglobin below 9.0 g/dL) or neutropenia (absolute neutrophil count [ANC] < 1000/mm^3)
* Prior history of multifocal adenocarcinoma in situ (ie, classic or pure bronchioloalveolar carcinoma)
* Prior history of keratoacanthoma (well differentiated squamous cell skin cancer variant, often centrally ulcerated); history of basal cell cancer is allowed
* Pre malignant skin lesion(s) noted on prescreening skin exam, except for actinic (solar) keratosis
* Prior radiotherapy overlapping with high dose region of planned SABR course
* Prior history of head and neck; oral; or bladder cancer
* Prior receipt of systemic treatment (chemotherapy, targeted therapy, or immunotherapy) for the lesion under consideration of treatment
* Uncontrolled, inter current or recent illness that in the investigator's opinion precludes participation in the study, including those undergoing therapy for a separate invasive malignancy
* Contraindication to receiving radiotherapy
* Known allergy to components of fresolimumab
* Pregnant or breastfeeding. All women of child bearing potential (last menstrual period within the previous 12 months and not surgically sterile) will be tested for pregnancy at pre entry.
|
NCT_ID
NCT02581787
|
Study_NameSABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer
| 18,457 |
Study Objectives
The primary objective of this study is as follows:
* To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors.
The secondary objectives of this study are as follows:
* To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors,
* To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors.
The exploratory objective of this study is as follows:
* To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells.
In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study:
* Long-term safety and tolerability of XL647 after repeat administration,
* Tumor response after repeat administration of XL647.
Conditions: Cancer
Intervention / Treatment:
DRUG: XL647
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:
* The subject has a histologically confirmed malignancy that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective,
* The subject has disease that is assessable by tumor marker, physical, or radiologic means,
* The subject is >=18 years,
* There have been at least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last treatment regimen included BCNU or mitomycin C),
* The subject has an ECOG performance status <=2 (Karnofsky >60%),
* The subject has a life expectancy of >=3 months,
* The subject has normal organ and marrow function (hemoglobin >10g/dL, leukocytes >3,000/mL, absolute neutrophil count >1,500/µL, platelets >100,000/µL, total bilirubin within normal institutional limits of normal,AST (SGOT)/ALT(SGPT) <2.5 times the upper limit of normal, and creatinine within normal limits,
* The subject is capable of understanding and complying with the protocol and has signed the informed consent document,
* Sexually active subjects (both male and female) must use an accepted method of contraception during the course of the study,
* Female subjects of childbearing potential (pre-menopausal) must have a negative pregnancy test.
Exclusion Criteria:
* The subject has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or has not recovered from AEs due to agents administered more than 4 weeks earlier,
* The subject has received another investigational agent within 30 days (or 5.5 half-lives) of the first dose of study drug,
* The subject has known brain metastases,
* The subject has a corrected QT interval (QTc) of >0.44 seconds,
* The subject has a history of allergic reactions attributed to aspartame or to any other component in the formulation vehicle,
* The subject has an 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,
* The subject is pregnant or nursing,
* The subject is known to be positive for the human immunodeficiency virus (HIV).
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NCT_ID
NCT00086528
|
Study_NameSafety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
| 20,842 |
Study Objectives
The goal of this clinical research study is to find the highest tolerable dose of 2 different combinations of drugs that can be given to patients with advanced cancer. The first combination of drugs is Tykerb (lapatinib) and Rapamune (sirolimus), and the second combination is lapatinib and Glucophage (metformin). The safety of these drug combinations will also be studied.
Conditions: Advanced Cancers
Intervention / Treatment:
DRUG: Lapatinib, DRUG: Sirolimus, DRUG: Metformin
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:
* Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
* Patients must be at least 3 weeks beyond their previous cytotoxic treatment. Patient must wait at least 5 half-lives or 3 weeks, whichever is shorter, from their previous targeted or biologic therapy; In addition, patients must be at least 3 weeks beyond the last session of radiation therapy or major surgery. Local palliative radiation therapy that is not delivered to all target lesions is allowed immediately before or during treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status should be less or equal to 3
* Patients must have normal organ and marrow function defined as: absolute neutrophil count (ANC) >= 750/mL; platelets >= 50,000/mL; creatinine <= 2x upper limit of normal (ULN) for the Sirolimus Arm and creatinine < 1.5 mg/dl for the Metformin arm; total bilirubin <=2.0 (For patients with Gilbert syndrome, bilirubin level > 2 could will be allowed on study if the hyperbilirubinemia is believed to be secondary only to the Gilbert syndrome); ALT (SGPT) <= 5x ULN; Exception for patients with liver metastasis: total bilirubin <= 3x ULN; ALT (SGPT) <= 8x ULN.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose
* Patients must be able to understand and be willing to sign a written informed consent document
* Patients with treated brain metastases are allowed in both arms of the study.
Exclusion Criteria:
* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
* Pregnant or lactating women.
* History of hypersensitivity to Lapatinib or any component of the formulation.
* Patients who have malabsorption syndrome
* Patients with class III or IV congestive heart failure as defined by New York Heart Association functional classification system
* Patients unwilling or unable to sign informed consent document
* History of hypersensitivity to Sirolimus or any component of the formulation (for Lapatinib and Sirolimus arm only)
* History of hypersensitivity to metformin or any component of the formulation (for Lapatinib and Metformin arm only)
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NCT_ID
NCT01087983
|
Study_NameLapatinib With Sirolimus or Metformin
| 20,560 |
Study Objectives
This is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced breast cancer patients
Conditions: Cancer
Intervention / Treatment:
OTHER: non-drug intervention educational programme
Location: Pakistan, Singapore, Korea, Republic of, Hong Kong
Study Design and Phases
Study Type: OBSERVATIONAL
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Inclusion Criteria:
* Signed written informed consent;
* Female outpatient aged >= 18 years;
* Subjects must be about to begin their initial treatment with lapatinib + capecitabine for HER2+ metastatic or advanced breast cancer according to physician's clinical judgement as per local prescribing information
* Subjects must be literate, be able to read, understand and write local language.
Exclusion Criteria:
* Women who is participating in any other interventional clinical trials concurrently;
* Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment;
* Primary lesions that are not of breast origin.
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NCT_ID
NCT01462604
|
Study_NamePilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer
| 9,829 |
Study Objectives
The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.
Symphogen was the sponsor for planning/conducting and reporting results for this trial.
Conditions: Carcinoma, Squamous Cell of Head and Neck
Intervention / Treatment:
DRUG: Sym004
Location: Belgium, Germany, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
* Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
* Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
* Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
* Documented disease progression (verified by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
* Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
* Other protocol-defined inclusion criteria could apply
Exclusion Criteria:
* More than 2 lines of prior chemotherapy in the palliative setting
* Expected survival <12 weeks
* Subjects with known brain metastases
* Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
* Anti-EGFR mAbs within 14 days prior to Visit 2
* Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from effects of major surgery
* Other protocol-defined exclusion criteria could apply
|
NCT_ID
NCT01417936
|
Study_NameSym004 in SCCHN Patients Failing Anti-EGFR Based Therapy
| 8,410 |
Study Objectives
This is a Phase 1, open label study to assess the safety and tolerability of U3 1565, determine maximum tolerated dose (MTD) or establish maximum administered dose (MAD) safety and tolerability.
Conditions: Advanced Solid Malignant Tumors, Advanced Ovarian Cancer
Intervention / Treatment:
DRUG: U3-1565
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:
* Pathologically documented advanced solid malignant tumor refractory to standard treatment or for which no standard treatment is available.
* Evaluable tumor for all parts of the study and, only for enrollment in Part 2b, measurable tumor per RECIST version 1.1. However, subjects with advanced ovarian cancer may be enrolled in Part 2b even if they do not have a tumor measurable per RECIST version 1.1, as long as they have circulating levels of CA125 higher than 35 U/mL.
* Eastern Cooperative Oncology Group (ECOG) performance status =< 1.
* Men or women >= 18 years.
* Willing to provide pre-existing diagnostic or resected tumor samples, such as paraffin embedded sections, if available.
* Willing, only for enrollment in Part 2b, to provide tumor biopsies before and after treatment.
* For female subjects, is postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile or, if otherwise of childbearing potential, has a negative urine or serum pregnancy test at entry into the study, uses maximally effective birth control during the course of the study, and is willing to use contraception for 6 months following the last study drug administration.
* For male subjects, is surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last study drug administration.
* Able to comprehend, sign, and date current Institutional Review Board- (IRB) approved informed consent form (ICF - including Health Insurance Portability and Accountability Act [HIPAA] authorization, if applicable) before performance of any study-specific procedures or tests.
Exclusion Criteria:
* History of lymphoma, leukemia, or other hematopoietic malignancy.
* History of human immunodeficiency virus (HIV) positivity. HIV testing is not required for establishing eligibility.
* History of bleeding diathesis.
* History of idiosyncratic reactions to antibody drug products.
* History of stem cell or bone marrow transplant.
* History of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF; New York Heart Association > Class II), unstable angina or unstable cardiac arrhythmia requiring medication
* History of clinically significant pulmonary disease after receiving epidermal growth factor receptor- (EGFR) targeting agents.
* Any concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
* Clinically active brain metastases defined as symptomatic or requiring treatment with steroids or anti-convulsants.
* Unresolved toxicities from prior anti-cancer therapy defined as toxicities, except alopecia, not yet resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade =< 1 or baseline values. Subjects with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator or Sponsor (eg, Grade 2 chemotherapy-induced neuropathy).
* Mean QTcF (Fridericia's correction) intervals > 450 msec for male subjects and > 470 msec for female subjects, based on screening electrocardiogram (ECG).
* Moderate to severe cardiac valvular abnormalities identified by echocardiography at screening.
* Hematological values, as follows:
Absolute neutrophil count (ANC) < 1.5 X 109/L Platelet count < 100 X 109/L Hemoglobin (Hb) < 9 g/dL - Renal function, as follows: Creatinine > 1.5 X upper limit of normal (ULN) or creatinine clearance < 60 mL/min, as calculated using the modified Cockcroft Gault equation.
* Hepatic function, as follows: Aspartate aminotransferase (AST) > 3 X ULN (if liver metastases are present, > 5 X ULN).
Alanine aminotransferase (ALT) > 3 X ULN (if liver metastases are present, >= 5 X ULN)
* Bilirubin > 1.5 X ULN
* Coagulation function, as follows:
Prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 X ULN
* Anti-cancer therapy, including antibody, retinoid, or hormonal treatment, within 3 weeks before enrollment. Prior and concurrent use of hormone replacement therapy, use of gonadotropin-releasing hormone modulators for prostate cancer, and use of somatostatin analogs for neuroendocrine tumors are permitted.
* Therapeutic radiation treatment within 4 weeks or palliative radiation treatment within 2 weeks before enrollment, as long as radiation toxicities have resolved to NCI CTCAE grade =< 1 or baseline values.
* Major surgery within 4 weeks before enrollment.
|
NCT_ID
NCT01290471
|
Study_NameStudy to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors
| 19,656 |
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