The primary objective of this prospective, randomized, controlled trial is to compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma (RCC) who were treated with adjuvant high-dose interleukin-2 vs observation alone.
Patients are stratified according to their disease classification and randomized to one course of IL-2 \[600,000 U/kg every 8 hours on days 1 to 5 and days 15 to 19 (maximum 28 doses)\] or observation.
