Bortezomib in Treating Patients With Metastatic Kidney Cancer
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients|
- Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses [ Time Frame: 2 months ]
|Study Start Date:||April 2006|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Velcade IV twice a week for two weeks on Days 1, 4, 8 and 11 of each cycle. A 10 day-rest period (Days 12-21) with no Velcade will follow the 2 weeks of treatment in each cycle. one cycle = 21 days
- Determine, preliminarily, the efficacy of bortezomib in patients with metastatic non-clear cell renal cell carcinoma in terms of objective response rate after a minimum of 2 courses of treatment.
- Correlate clinical response in these patients with baseline von Hippel-Lindau expression and nuclear factor-KB activity.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month and then periodically for 2 years.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276614
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Matthew B. Rettig, MD||Jonsson Comprehensive Cancer Center|