Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma|
|Study Start Date:||June 1997|
|Study Completion Date:||August 2002|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
- 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.
|United States, California|
|Cancer Center and Beckman Research Institute, City of Hope|
|Duarte, California, United States, 91010-3000|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|Summit Medical Center|
|Oakland, California, United States, 94609|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0752|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, New York|
|Our Lady of Mercy Medical Center|
|Bronx, New York, United States, 10466|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28232-2861|
|United States, Oregon|
|Earle A. Chiles Research Institute at Providence Portland Medical Center|
|Portland, Oregon, United States, 97213-2967|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|Study Chair:||Joseph I. Clark, MD||Loyola University|