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Sponsors and Collaborators: |
University of Arkansas Celgene Corporation |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083707 |
The purpose of this research is to study how helpful thalidomide is in controlling the disease and to study any side effects from taking thalidomide.
Condition | Intervention | Phase |
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Waldenstrom Macroglobulinemia |
Drug: Thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | UARK 99-006, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia |
Estimated Enrollment: | 40 |
Study Start Date: | January 1999 |
Estimated Study Completion Date: | February 2003 |
Patients will receive thalidomide in the oral form each night before bed. The dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects.
Routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. Blood tests will be done to monitor the tumor response.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
University of Arkansas for Medical Sciences/MIRT | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Athanasios Fassas, M.D. | UAMS |
Study ID Numbers: | UARK 99-006 |
Study First Received: | May 27, 2004 |
Last Updated: | November 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00083707 |
Health Authority: | United States: Food and Drug Administration |
Macroglobulinemia Waldenstrom Thalidomide |
Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Lymphatic Diseases Waldenstrom Macroglobulinemia Hemorrhagic Disorders Waldenstrom macroglobulinemia Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors |
Pharmacologic Actions Anti-Bacterial Agents Neoplasms Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |