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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00022555 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bryostatin 1 may help vincristine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus vincristine in treating patients who have recurrent or refractory lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: bryostatin 1 Drug: vincristine sulfate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Combination Bryostatin-1 and Vincristine in HIV-Related B-Cell Neoplasms |
Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of bryostatin 1.
Patients receive bryostatin 1 IV continuously on days 1 and 15 and vincristine IV over 5 minutes on days 2 and 16. Treatment continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 9-12 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 B-cell lymphoma
Eligible subtypes:
Received at least 1 prior systemic chemotherapy regimen with failure to respond or relapse after completion of first-line therapy, including one of the following doxorubicin-based combinations:
However,this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center | |
New York, New York, United States, 10032 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Scot C. Remick, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068830, AMC-029 |
Study First Received: | August 10, 2001 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00022555 History of Changes |
Health Authority: | United States: Federal Government |
AIDS-related peripheral/systemic lymphoma AIDS-related diffuse large cell lymphoma AIDS-related small noncleaved cell lymphoma AIDS-related diffuse mixed cell lymphoma |
Lymphoma, AIDS-related Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Immunologic Factors Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Vincristine Antimitotic Agents Bryostatin 1 Small Non-cleaved Cell Lymphoma Recurrence |
Lymphoma, B-Cell Lymphatic Diseases B-cell Lymphomas Lymphoma, AIDS-Related HIV Infections Tubulin Modulators Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, Large-cell Antineoplastic Agents, Phytogenic Lymphoma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Adjuvants, Immunologic Vincristine Antimitotic Agents Bryostatin 1 |
Pharmacologic Actions Lymphoma, B-Cell Lymphatic Diseases Neoplasms Lymphoma, AIDS-Related Therapeutic Uses Tubulin Modulators Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Lymphoma |