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Sponsors and Collaborators: |
Massey Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005580 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: bryostatin 1 Drug: fludarabine phosphate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Bryostatin 1 (NSC 339555) and Fludarabine in Patients With Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma |
Study Start Date: | September 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to one of two treatment groups.
In both groups, courses repeat every 4 weeks for patients with stable or responding disease.
Cohorts of 3-6 patients receive escalating doses of fludarabine and 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. Once the MTD for fludarabine is determined, the dose of bryostatin
1 is escalated.
PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed chronic lymphocytic leukemia
Histologically confirmed indolent non-Hodgkin's lymphoma
Includes the following histologies:
B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/lymphomas
Follicular lymphoma
Marginal zone B-cell lymphoma
Peripheral T-cell and NK-cell neoplasms
Large granular lymphocyte leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
New York Presbyterian Hospital - Cornell Campus | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Virginia | |
Massey Cancer Center | |
Richmond, Virginia, United States, 23298-0037 |
Study Chair: | Steven Grant, MD | Massey Cancer Center |
Study ID Numbers: | CDR0000066433, MCV-CCHR-9801-2C, NCI-T97-0116 |
Study First Received: | May 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005580 History of Changes |
Health Authority: | United States: Federal Government |
recurrent cutaneous T-cell non-Hodgkin lymphoma Waldenstrom macroglobulinemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia B-cell chronic lymphocytic leukemia refractory hairy cell leukemia recurrent grade 1 follicular lymphoma |
recurrent grade 2 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult T-cell leukemia/lymphoma prolymphocytic leukemia recurrent mantle cell lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Antimetabolites Leukemia, Lymphoid Immunologic Factors Large Granular Lymphocyte Leukemia Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Follicular Lymphoma Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Mycoses |
Leukemia, Prolymphocytic Cutaneous T-cell Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Leukemia, B-cell, Chronic Lymphoma Prolymphocytic Leukemia Immunoproliferative Disorders Leukemia-Lymphoma, Adult T-Cell Hairy Cell Leukemia Adjuvants, Immunologic Bryostatin 1 Fludarabine monophosphate Immunosuppressive Agents Recurrence |
Antimetabolites Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Adjuvants, Immunologic Bryostatin 1 Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Leukemia, B-Cell |