NCT00276614

Bortezomib in Treating Patients With Metastatic Kidney Cancer

A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	bortezomib

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-01-13
• Last updated: 2020-09-01
• Results posted: 2012-04-19

Locations

1 site across 1 country: United States