Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis

Inclusion Criteria: Progressive histologically proven metastatic renal cell carcinoma. Patient with only 1 metastatic site and Karnofsky = 80% or more than 1 metastatic site and Karnofsky >= 80%. Age >= 18 No wide-field radiation therapy for 6 weeks at least. No active brain metastasis. Blood values within limits of normal (hematocrit > 30% and leukocyte count >= 4x109/l and platelet count >= 120x109/l). Creatinine < 150 µmol/l and bilirubin <= normal. Female patients of childbearing potential: effective method of contraception is necessary. Written, voluntary, informed consent. Exclusion Criteria: Previous treatment with cytokines. Only one metastatic organ and Karnofsky = 90% or 100% (inclusion in good prognosis group). More than one metastatic organ (at least one metastasis to the liver) and <12 months between initial diagnosis and diagnosis of metastasis. Active brain metastases. Patient with concurrent grade III/IV heart disorder (congestive heart failure, coronary artery disease, uncontrolled hypertension, severe arrhythmia, etc) and/or stroke volume < 50%. Severe pulmonary, hepatic, or renal disease potentially aggravated by treatment. Severe concurrent infection necessitating antibiotics Patient with known HIV or AIDS-related disease, or presence of HB antigen or known chronic hepatitis. Previous allograft. Patient under corticosteroid treatment. Previous or concurrent primary malignancies at other sites (except from baso-cellular skin cancer or cervical cancer in situ) Pregnant or lactating woman. Follow-up difficult because of geography or personal circumstances.