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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.
- 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.
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
Cancer Center and Beckman Research Institute, City of Hope
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:52-0400
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