Status:
TERMINATED
Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the p...
Detailed Description
OBJECTIVES: Primary * Determine progression-free survival of patients with metastatic clear cell renal cell carcinoma treated with sunitinib and irradiated allogeneic lymphocytes. Secondary * Dete...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma
- Primary lesion or metastatic site demonstrating clear cell variant with \< 25% of any other histology
- Radiographically measurable disease by RECIST criteria
- Initiated treatment with sunitinib malate ≤ 6 weeks ago
- No radiographically detectable brain metastases by MRI or CT scan
- HLA-partially matched related donor available, as determined by serologic and/or DNA typing
- Appropriate HLA match (≥ 2/6 HLA A, B, DR match)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
- AST ≤ 3.0 times ULN
- Calculated creatinine clearance ≥ 40 mL/min
- Cardiac ejection fraction ≥ 50%
- QTc interval \< 500 msec by EKG
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- None of the following within the past 6 months:
- Myocardial infarction
- Severe/unstable angina
- Coronary/peripheral artery bypass graft
- Symptomatic congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- No ongoing ventricular cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
- No history of serious ventricular arrhythmia (e.g., ventricular tachycardia \> 3 beats in a row)
- No ongoing atrial fibrillation
- No other malignancies within the past 3 years, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast
- No other concurrent serious illness
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic therapy for metastatic renal cell carcinoma
- No prior immunotherapy
- No prior VEGF-targeted or mTOR-targeted therapies
- No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), St. John's wort, ketoconazole, dexamethasone, dysrhythmic drugs (e.g., terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
- No other concurrent investigational anticancer agents
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00853125
Start Date
February 1 2009
End Date
February 22 2014
Last Update
April 27 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903