RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with no further therapy in treating patients with stage III or stage IV kidney cancer.

OBJECTIVES:

• Compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma treated with adjuvant high-dose interleukin-2 vs observation alone.
• Determine the overall tolerability, toxicity, and safety of adjuvant high-dose interleukin-2 in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease classification (T3b (N0) or N1 (T1-3b) vs T3c or T4 (N0-1) vs N2 or N3 disease (T1-4) vs M1 disease resected to no evaluable disease). Within 3-12 weeks after radical nephrectomy and/or resection of metastases, patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive high-dose interleukin-2 IV over 15 minutes every 8 hours on days 1-5 and 15-19 for a maximum of 28 doses.
• Arm II: Patients undergo observation alone. Patients may receive treatment as in arm I beginning at the first sign of recurrence.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

• Histologically proven high-risk renal cell carcinoma that has been completely resected within the past 12 weeks

  • T3b (N0); N1 (T1-3b); T3c or T4 (N0-1); N2 or N3 (T1-4) disease OR
  • M1 disease resected to no evaluable disease
• Postoperative radiographic evaluation must reveal no evidence of detectable residual disease
• No ascites or pleural effusions
• No detectable metastases

PATIENT CHARACTERISTICS:

Age

• 16 and over

Performance status

• ECOG 0-1 OR
• Karnofsky 80-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 4,000/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin no greater than 1.5 mg/dL

Renal

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No congestive heart failure
• No symptoms of coronary artery disease
• No serious cardiac arrhythmias
• No prior myocardial infarction
• Normal cardiac stress test required if over age 40

Pulmonary

• FEV1 greater than 2.0 liters or at least 75% predicted for height and age
• No chronic obstructive pulmonary disease

Other

• HIV negative
• No significant detectable infection
• No other significant medical disease
• No other invasive malignancy within the past 5 years except surgically cured nonmelanomatous skin cancer or carcinoma in situ or stage I carcinoma of the cervix
• No contraindication to pressor agents
• No seizure disorder
• No psychiatric illness that would preclude informed consent
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior interleukin-2 for renal cell carcinoma

Chemotherapy

• No prior systemic chemotherapy for renal cell carcinoma

Endocrine therapy

• No concurrent steroids

Radiotherapy

• Prior locoregional radiotherapy to solitary resectable metastases allowed

Surgery

• See Disease Characteristics
• Recovered from prior surgical resection
• No prior organ allografts

Other

• No other prior systemic therapy for renal cell carcinoma