Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Recruitment status was Recruiting
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study|
- Response [ Designated as safety issue: No ]
- Progression-free and overall survival [ Designated as safety issue: No ]
- Comparison of response and survival with historical data [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Time to disease progression [ Designated as safety issue: No ]
- Pharmacokinetics and pharmacodynamics [ Designated as safety issue: No ]
- Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival [ Designated as safety issue: Yes ]
- Utility of known prognostic criteria [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301990
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA||Recruiting|
|Los Angeles, California, United States, 90095-1781|
|Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719|
|United States, Illinois|
|Cardinal Bernardin Cancer Center at Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202-5289|
|Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201-1379|
|Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756-0002|
|Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 email@example.com|
|United States, New York|
|Our Lady of Mercy Medical Center Comprehensive Cancer Center||Recruiting|
|Bronx, New York, United States, 10466|
|Contact: Janice P. Dutcher, MD 718-304-7200|
|United States, Oregon|
|Providence Cancer Center at Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213-2967|
|Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412|
|United States, Pennsylvania|
|UPMC Cancer Centers||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232-6838|
|Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480|
|United States, Virginia|
|University of Virginia Cancer Center||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Geoffrey R. Weiss, MD 434-243-0066 firstname.lastname@example.org|
|Study Chair:||Fairooz F. Kabbinavar, MD||Jonsson Comprehensive Cancer Center|