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Sponsors and Collaborators: |
National Institute on Aging (NIA) National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00087425 |
RATIONALE: Drugs used in chemotherapy, such as bryostatin 1, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Bryostatin 1 may help rituximab kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving bryostatin 1 together with rituximab works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia that has not responded to previous treatment with rituximab.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: bryostatin 1 Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial Of Bryostatin-1 In Combination With Rituximab In Rituximab-Refractory Indolent B-Cell Non Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 48 |
Study Start Date: | July 2004 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV continuously over 24 hours on days -6, 2, and 9 of course 1 and on days 2 and 9 of courses 2-6. Patients also receive rituximab IV over 4 hours on days 1, 8, 15, and 22 of courses 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 18-48 patients (9-24 with non-Hodgkin's lymphoma and 9-24 with chronic lymphocytic leukemia) will be accrued for this study within 12-30 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically or cytologically confirmed diseases:
Indolent B-cell non-Hodgkin's lymphoma (NHL)
Chronic lymphocytic leukemia (CLL) meeting 1 of the following risk criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No history of anaphylaxis or immunoglobulin (Ig) E-mediated hypersensitivity to murine protein
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
NIH - Warren Grant Magnuson Clinical Center | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Igor Espinoza-Delgado, MD | Gerontology Research Center |
Study ID Numbers: | CDR0000377250, NIA-CII0301, NCI-6216 |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00087425 |
Health Authority: | United States: Food and Drug Administration |
contiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma recurrent adult diffuse small cleaved cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma contiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma recurrent grade 1 follicular lymphoma stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma recurrent grade 2 follicular lymphoma stage III grade 2 follicular lymphoma |
stage IV grade 2 follicular lymphoma contiguous stage II marginal zone lymphoma noncontiguous stage II marginal zone lymphoma recurrent marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma refractory chronic lymphocytic leukemia Waldenstrom macroglobulinemia contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Bryostatin 1 Recurrence Lymphoma, B-Cell Leukemia |
Lymphatic Diseases Waldenstrom Macroglobulinemia Leukemia, Lymphocytic, Chronic, B-Cell B-cell lymphomas Waldenstrom macroglobulinemia Lymphoma, Non-Hodgkin Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Adjuvants, Immunologic Antirheumatic Agents Pharmacologic Actions |