Kidney Cancer Clinical Trial
Official title:
A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
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