Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic renal cell cancer Progressive disease after treatment with 0-2 courses of immunotherapy, chemotherapy, or other systemic therapy for advanced disease Measurable or evaluable disease No concurrent CNS metastases Prior CNS metastases allowed if no residual disease by MRI PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal Creatinine less than 2 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular No unstable angina No myocardial infarction within the past 6 months Other Cholesterol no greater than 350 mg/dL Triglycerides no greater than 400 mg/dL HIV negative Not immunocompromised No active autoimmune disorder No active infection requiring antibiotic therapy No other serious concurrent illness No known hypersensitivity to components of CCI-779, interferon alfa, diphenhydramine hydrochloride, or both acetaminophen and nonsteroidal anti- inflammatory drugs No other major illness that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 3 weeks since prior immunotherapy No prior interferon alfa No other concurrent immunotherapy No prophylactic growth factors Concurrent epoetin alfa allowed Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy No prior CCI-779 No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy for malignancy (megestrol for appetite loss allowed) Concurrent inhaled or replacement steroids allowed Radiotherapy At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery At least 3 weeks since prior surgery Other See Disease Characteristics At least 3 weeks since prior immunosuppressive agents At least 4 weeks since prior investigational agents No other concurrent investigational agents No concurrent immunosuppressive therapy No concurrent anticonvulsants known to be cytochrome P450 inducers, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide No concurrent maintenance therapy for life-threatening ventricular arrhythmia
Sites / Locations
- Memorial Sloan-Kettering Cancer Center