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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066508 |
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 diffuse large B-cell lymphoma that is refractory to previous chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) |
Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 20 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma, meeting criteria for 1 of the following:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 50,000/mm^3
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095 |
Study Chair: | Sven De Vos, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000316254, UCLA-0301090 |
Study First Received: | August 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00066508 |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders B-cell lymphomas |
Bortezomib Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Recurrence |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |