Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer

OBJECTIVES:

• Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil vs observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive interleukin-2 subcutaneously (SC) on days 3, 4, and 5 of weeks 1 and 4 and on days 1, 3, and 5 of weeks 2 and 3. Patients also receive interferon alfa SC once weekly during weeks 1 and 4 and 3 times weekly during weeks 2, 3, 5, 6, 7, and 8. Patients then receive fluorouracil IV on day 1 of weeks 5, 6, 7, and 8.
• Arm II (control arm): Patients receive no adjuvant treatment before disease progression.

Quality of life is assessed at baseline and at 2 and 6 months after randomization.

Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed primary renal cell carcinoma meeting 1 of the following criteria:

• Stage T3b, T3c, or T4 tumor
• Any pT stage and nodal status pN 1 or 2
• Any pT stage and microscopic positive margins
• Presence of any microscopic vascular invasion
• Underwent surgical resection of primary tumor within the past month

• Removal of clinical N+ disease required
• No evidence of metastatic disease
• No evidence of macroscopic residual disease

PATIENT CHARACTERISTICS:

Age

• 75 and under

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Liver function tests no greater than 1.25 times upper limit of normal (ULN)

Renal

• Creatinine less than 1.5 times ULN

Cardiovascular

• No myocardial infarction within the past 6 months
• No unstable angina pectoris

Other

• Not pregnant or nursing
• No prior or other concurrent malignancies that would preclude study therapy or comparisons
• No other concurrent illness that would preclude study therapy
• No concurrent active infections requiring antibiotic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No other concurrent immunotherapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No concurrent corticosteroids
• No concurrent hormonal therapy

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics
• No prior major organ allografts

Other

• No other concurrent investigational drugs, agents, or devices