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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058227 |
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as flavopiridol and fludarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects, best way to give, and the best dose of flavopiridol when given together with fludarabine and rituximab in treating patients with previously untreated or relapsed lymphoproliferative disorders or mantle cell lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: alvocidib Drug: fludarabine phosphate Drug: rituximab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Flavopiridol, Fludarabine and Rituximab in Indolent B-Cell Lymphoproliferative Disorders and Mantle Cell Lymphoma |
Estimated Enrollment: | 37 |
Study Start Date: | April 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive fludarabine IV over 15-30 minutes on days 1-5 and rituximab IV over 3-4 hours on day 1. Flavopiridol is administered IV over 60 minutes on day 1 in cohort 1; on days 1 and 2 in cohort 2; and on days 1, 2, and 3 in cohort 3. In cohorts 4 and 5, patients receive fludarabine and rituximab as above and flavopiridol IV over 30 minutes and then IV over 4 hours on day 1 of courses 2-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
A total of 10-12 patients are treated with flavopiridol at the maximum tolerated dose.
PROJECTED ACCRUAL: A total of 37 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 mantle cell lymphoma OR indolent B-cell lymphoproliferative disorders of any of the following types:
Evaluable disease with presence of 1 of the following criteria:
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, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 |
Study Chair: | Thomas S. Lin, MD, PhD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000287196, OSU-02H0281, OSU-0211, NCI-5745 |
Study First Received: | April 7, 2003 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00058227 |
Health Authority: | United States: Food and Drug Administration |
B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia untreated hairy cell leukemia Waldenstrom macroglobulinemia progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage I mantle cell lymphoma stage III mantle cell lymphoma |
stage IV mantle cell lymphoma recurrent mantle cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma contiguous stage II small lymphocytic lymphoma |
Leukemia, Lymphoid Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Lymphoma, B-Cell Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Waldenstrom macroglobulinemia Lymphoma Chronic lymphocytic leukemia Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic |
Fludarabine monophosphate Mantle cell lymphoma Recurrence Flavopiridol Lymphatic Diseases Leukemia, Hairy Cell Waldenstrom Macroglobulinemia B-cell lymphomas Fludarabine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Hairy cell leukemia Follicular lymphoma |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Growth Inhibitors Antirheumatic Agents |