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)

Criterios de inclusión

• Endocrine therapy
• 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
• 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
• 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)