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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052416 |
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: thalidomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Thalidomide in Indolent Non-Hodgkin's Lymphoma: A Feasibility Study |
Study Start Date: | October 2002 |
OBJECTIVES:
OUTLINE: Patients receive oral thalidomide once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, monthly during study, and at the end of the study.
PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed indolent lymphoma or leukemia of one of the following subtypes:
Considered appropriate for expectant management
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No poorly controlled diabetes defined by either of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Vermont | |
Fletcher Allen Health Care - University Health Center Campus | |
Burlington, Vermont, United States, 05401 |
Study Chair: | Robin Joyce, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000258419, BIDMC-W-01-0384-FB, NEDH-W-01-0384-FB, BIDMC-2001-P-001950, NCI-V02-1714 |
Study First Received: | January 24, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00052416 History of Changes |
Health Authority: | United States: Federal Government |
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 stage I grade 1 follicular lymphoma stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma contiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma stage I grade 2 follicular lymphoma stage III grade 2 follicular lymphoma |
stage IV grade 2 follicular lymphoma Waldenstrom macroglobulinemia contiguous stage II marginal zone lymphoma contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma noncontiguous stage II marginal zone lymphoma stage I marginal zone lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage III marginal zone lymphoma stage IV small lymphocytic lymphoma stage IV marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Anti-Infective Agents Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Thalidomide Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Angiogenesis Inhibitors Immunosuppressive Agents Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell |
Anti-Bacterial Agents Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia Waldenstrom Macroglobulinemia B-cell Lymphomas Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoma, Non-Hodgkin Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |
Anti-Infective Agents Leukemia, Lymphoid Thalidomide Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia Anti-Bacterial Agents Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Lymphoma |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Growth Substances Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Lymphatic Diseases Neoplasms Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Leukemia, B-Cell Leprostatic Agents |