A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study
OBJECTIVES:
Primary
- Estimate the response, progression-free survival, and overall survival of patients with
metastatic renal cell carcinoma (RCC) treated with bevacizumab and high-dose
interleukin-2 (IL-2).
Secondary
- Compare the response and survival of patients with metastatic RCC treated with
bevacizumab and high-dose IL-2 with the historical data of patients treated with
high-dose IL-2 alone.
- Compare the toxicity of bevacizumab and high-dose IL-2 in patients with metastatic RCC
with the historical data of patients treated with high-dose IL-2 alone, in terms of
number of doses of IL-2 administered during the first course of therapy, toxicity after
the scheduled ninth dose of IL-2, and frequency of grade III and IV or unexpected or
rare toxicities.
- Compare the time to disease progression in patients with metastatic RCC treated with
bevacizumab and high-dose IL-2 with the historical data of patients treated with
high-dose IL-2 alone.
- Evaluate the pharmacokinetics and pharmacodynamics of bevacizumab and high-dose IL-2
during course 1.
- Correlate serum vascular endothelial growth factor (VEGF) levels, DC function, TCR zeta
chain expression, and arginase or arginine levels with toxicity, response, and survival
of patients treated with this regimen.
- Evaluate the utility of known prognostic criteria for RCC patients on clinical outcome.
OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (good
vs intermediate vs poor).
Patients receive bevacizumab IV over 30-90 minutes on days -13, 1, 15, 29, 43, 57, and 71
during course 1 and on days 1, 15, 29, 43, 57, and 71 during courses 2 and 3. Patients also
receive high-dose interleukin-2 every 8 hours on days 1-5 and 15-19. Treatment repeats every
84 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response
No
Fairooz F. Kabbinavar, MD
Study Chair
Jonsson Comprehensive Cancer Center
Unspecified
CDR0000460074
NCT00301990
September 2005
Name | Location |
---|---|
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |