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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030875 |
Purpose
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: | Treatment, Non-Randomized, Active Control |
| 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.
Eligibility| 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:
Contacts and Locations| 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 | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Study Chair: | Andrew R. Belch, MD | Cross Cancer Institute at University of Alberta |
More Information
| 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 |
|
stage I mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma |
stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma |
|
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 |