Bortezomib in Treating Patients With Mantle Cell Lymphoma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma|
|Study Start Date:||July 2002|
|Study Completion Date:||December 2009|
- Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed mantle cell lymphoma.
- Determine the toxicity of this drug in these patients.
- Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients.
- Determine the time to progression and response duration in patients treated with this drug.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 courses beyond documentation of CR. Patients with stable disease receive a maximum of 4 courses. Patients with partial response (PR) continue therapy until disease progression or for 2 courses beyond documentation of stable PR.
Patients are followed at 4 weeks and then every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030875
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Kingston Regional Cancer Centre|
|Kingston, Ontario, Canada, K7L 5P9|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Toronto Sunnybrook Regional Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Montreal, Quebec, Canada, H1T 2M4|
|Montreal, Quebec, Canada, H2W 1S6|
|Study Chair:||Andrew R. Belch, MD||Cross Cancer Institute at University of Alberta|