A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses
Matthew B. Rettig, MD
Jonsson Comprehensive Cancer Center
United States: Institutional Review Board
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|