Bortezomib in Treating Patients With Mantle Cell Lymphoma

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

OBJECTIVES: - 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00030875
Study type	Interventional
Source	Canadian Cancer Trials Group
Contact
Status	Completed
Phase	Phase 2
Start date	November 19, 2002
Completion date	December 21, 2009

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