Monoclonal Antibody Therapy in Treating Patients With Metastatic Renal Cell Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV clear cell renal carcinoma At least 1 site of measurable disease Meeting criteria for 1 of the following: Disease progression after prior interleukin-2 (IL-2) Ineligible for standard high-dose IV IL-2 due to comorbid medical conditions Minimal disease (lesions ≤ 3 cm that do not pose risk to organ function) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2 Indolent disease (defined as an increase in tumor size of < 50% within the past 6 months) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2 No true papillary, medullary, chromophobe, collecting duct, or oncocytic renal cancer PATIENT CHARACTERISTICS: Age 16 and over Performance status ECOG 0-1 Life expectancy At least 3 months Hematopoietic WBC ≥ 2,500/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Hematocrit ≥ 30% Hepatic AST ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ ULN (< 3.0 mg/dL for patients with Gilbert's syndrome) Hepatitis B surface antigen negative Hepatitis C antibody negative Renal Creatinine < 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No other malignancy except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for at least 5 years No autoimmune disease (including uveitis and autoimmune inflammatory eye disease) No active uncontrolled infection No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody At least 3 weeks since prior immunotherapy for renal cancer Chemotherapy At least 3 weeks since prior chemotherapy for renal cancer No concurrent chemotherapy Endocrine therapy At least 3 weeks since prior hormonal therapy for renal cancer More than 4 weeks since prior corticosteroids No concurrent systemic or topical corticosteroids Radiotherapy At least 3 weeks since prior radiotherapy for renal cancer Surgery Not specified Other Recovered from prior therapy At least 3 weeks since other prior therapy for renal cancer No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support