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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: | NCT00093769 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving bortezomib together with rituximab may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase II Study of VELCADE With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma |
Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (< 70% vs ≥ 70%), lactic dehydrogenase level (normal vs > upper limit of normal), age (18 to 60 years vs > 60 years), and lymphoma subtype (follicular vs marginal zone). Patients are randomized to 1 of 2 treatment arms.
Patients are followed at 30 days and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 24-66 patients (12-33 per treatment arm) will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
Relapsed or progressive disease after prior anti-neoplastic therapy, as indicated by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
No other malignancy within the past 5 years except completely resected basal cell or squamous cell skin cancer or an in situ malignancy
Previously diagnosed prostate cancer allowed provided the following criteria are met:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent investigational agents
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Sven De Vos, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000390235, UCLA-0401054-01, MILLENNIUM-M34103-061 |
Study First Received: | October 6, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00093769 History of Changes |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |
nodal marginal zone B-cell lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma |
Immunoproliferative Disorders Immunologic Factors Rituximab Bortezomib Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Follicular Lymphoma Recurrence Protease Inhibitors |
Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases B-cell Lymphomas Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Bortezomib Physiological Effects of Drugs Enzyme Inhibitors |
Pharmacologic Actions Protease Inhibitors Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |