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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Andrew R. Belch, MD
Affiliation: Cross Cancer Institute at University of Alberta
Role: STUDY_CHAIR