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Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00009984 |
RATIONALE: Thalidomide may stop the growth of hematologic cancer by stopping blood flow to the cancer. Combining thalidomide with fludarabine may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drug. It is not yet known whether thalidomide is more effective with or without fludarabine for hematologic cancer.
PURPOSE: This randomized phase II trial is studying thalidomide and fludarabine to see how well they work compared to thalidomide alone in treating patients with hematologic cancer that has not responded to previous treatment with fludarabine.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: fludarabine phosphate Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Phase II Study Of Thalidomide Versus Thalidomide Plus Fludarabine For Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine |
Estimated Enrollment: | 70 |
Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are stratified according to time to relapse from last fludarabine treatment (less than 6 months vs more than 6 months). Patients are randomized to one of two treatment arms.
PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per treatment arm) will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
Confirmed chronic lymphocytic leukemia (CLL), meeting the following criteria:
Relapsed or refractory disease
Meets one of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 | |
NYU Cancer Institute at New York University Medical Center | |
New York, New York, United States, 10016 |
Study Chair: | Richard R. Furman, MD | Weill Medical College of Cornell University |
Study ID Numbers: | CDR0000068429, NYWCCC-MTS-00-0535ME, NCI-639 |
Study First Received: | February 2, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00009984 History of Changes |
Health Authority: | United States: Food and Drug Administration |
refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma |
Antimetabolites Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Hematologic Neoplasms Thalidomide Fludarabine monophosphate Angiogenesis Inhibitors Immunosuppressive Agents Recurrence |
Anti-Bacterial Agents Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Lymphoma |
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia Anti-Bacterial Agents Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Growth Substances Fludarabine monophosphate Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine Lymphoproliferative Disorders Leukemia, B-Cell Leprostatic Agents |