A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
- 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
- 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
- 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, Primary Purpose: Treatment
Joseph I. Clark, MD
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Loyola University Medical Center||Maywood, Illinois 60153|
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Summit Medical Center||Oakland, California 94609|
|Our Lady of Mercy Medical Center||Bronx, New York 10466|
|Earle A. Chiles Research Institute at Providence Portland Medical Center||Portland, Oregon 97213-2967|