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Spots Global Cancer Trial Database for Bortezomib in Treating Patients With Mantle Cell Lymphoma

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Trial Identification

Brief Title: Bortezomib in Treating Patients With Mantle Cell Lymphoma

Official Title: A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma

Study ID: NCT00030875

Conditions

Lymphoma

Interventions

bortezomib

Study Description

Brief 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.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cross Cancer Institute, Edmonton, Alberta, Canada

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada

Kingston Regional Cancer Centre, Kingston, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada

Princess Margaret Hospital, Toronto, Ontario, Canada

Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada

McGill University, Montreal, Quebec, Canada

Contact Details

Name: Andrew R. Belch, MD

Affiliation: Cross Cancer Institute at University of Alberta

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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