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Sponsors and Collaborators: |
University of Vermont National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005579 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with indolent lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: dolastatin 10 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia |
Study Start Date: | June 1998 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study. Patients are stratified by disease (chronic lymphocytic leukemia vs indolent lymphoma vs Waldenstrom's macroglobulinemia).
All patients receive dolastatin 10 IV bolus every 3 weeks. Patients continue treatment until disease progression, unacceptable toxicity, or patient's withdrawal from the study.
PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study over 15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Waldenstrom's macroglobulinemia must have at least one of the following:
Chronic lymphocytic leukemia must be intermediate or high risk stages I-IV and have progressed on fludarabine therapy unless patient cannot tolerate fludarabine
Intermediate risk group must have at least one indication of active disease:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Maryland | |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Ohio | |
Arthur G. James Cancer Hospital - Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
United States, Vermont | |
Vermont Cancer Center | |
Burlington, Vermont, United States, 05401-3498 |
Study Chair: | Steven M. Grunberg, MD | University of Vermont |
Study ID Numbers: | CDR0000066360, VCC-9802, NCI-T98-0007 |
Study First Received: | May 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005579 History of Changes |
Health Authority: | United States: Federal Government |
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 stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma |
stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma |
Leukemia, Lymphoid Blood Protein Disorders Lymphoma, Follicular Paraproteinemias Hemostatic Disorders Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoma Dolastatin 10 Immunoproliferative Disorders |
Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Antimitotic Agents Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Chronic Lymphocytic Leukemia Tubulin Modulators Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma, Non-Hodgkin Neoplasms, Plasma Cell |
Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Paraproteinemias Hemostatic Disorders Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Cardiovascular Diseases Lymphoma Dolastatin 10 Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Hematologic Diseases Mitosis Modulators Vascular Diseases Antimitotic Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Waldenstrom Macroglobulinemia Tubulin Modulators Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Leukemia, B-Cell Neoplasms, Plasma Cell |