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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030875 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Active Control, Non-Randomized, 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma
At least 1 bidimensionally measurable disease site*
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular
Pulmonary
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
No more than 2 prior systemic chemotherapy regimens
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, British Columbia | |
British Columbia Cancer Agency | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Canada, Manitoba | |
CancerCare Manitoba | |
Winnipeg, Manitoba, Canada, R3E 0V9 | |
Canada, Ontario | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Kingston Regional Cancer Centre | |
Kingston, Ontario, Canada, K7L 5P9 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Toronto Sunnybrook Regional Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Margaret and Charles Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Canada, Quebec | |
McGill University | |
Montreal, Quebec, Canada, H2W 1S6 | |
Maisonneuve-Rosemont Hospital | |
Montreal, Quebec, Canada, H1T 2M4 |
Study Chair: | Andrew R. Belch, MD | Cross Cancer Institute at University of Alberta |
Study ID Numbers: | CDR0000069207, CAN-NCIC-IND150 |
Study First Received: | February 14, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00030875 History of Changes |
Health Authority: | United States: Federal Government |
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma recurrent mantle cell lymphoma |
stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, Mantle-Cell Bortezomib Mantle Cell Lymphoma |
Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Recurrence Protease Inhibitors |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Lymphoma, Mantle-Cell Bortezomib Enzyme Inhibitors |
Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |