A Randomized, Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence (ARISER)

Date de début de l'étude : 1 juillet 2004

DISEASE CHARACTERISTICS: * Histologically confirmed primary clear cell renal cell carcinoma * Meets 1 of the following high risk criteria: * T3a, N0/NX, M0 OR T3b, N0/NX, M0 OR T3c, N0/NX, M0 OR T4, N0/NX, M0 * Any T stage and N + disease and M0 * T1b, N0/NX, M0 OR T2, N0/NX, M0, each with grade ≥ 3 (Fuhrman or any other nuclear grading system with at least 3 grades) * Prior nephrectomy (total or partial) of primary renal cell carcinoma with documented clear cell histology within the past 12 weeks * No evidence of macroscopic or microscopic residual disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Platelet count \> 100,000/mm\^3 * WBC \> 3,000/mm\^3 * Hemoglobin \> 10 g/dL Hepatic * AST and ALT \< 3 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Hepatitis B surface antigen (HbsAg) negative * Hepatitis C antibody negative Renal * Creatinine \< 2.0 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV I and II negative * No concurrent unrelated illness which can significantly jeopardize patients' clinical status * No active infection * No inflammation * No medical condition or laboratory abnormalities that would preclude study participation * No other malignancies within the past 5 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * More than 5 years since prior immunotherapy * No prior murine or chimeric antibody therapy Chemotherapy * More than 5 years since prior chemotherapy Endocrine therapy * No concurrent corticosteroids above Cushing dose for another disease * Physiologic corticosteroid replacement therapy allowed at discretion of the primary investigator Radiotherapy * More than 5 years since prior radiotherapy Surgery * See Disease Characteristics * No prior organ transplantation Other * No concurrent immunosuppressive agents (e.g., cyclosporine or tacrolimus)