Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia
This study has been completed.
Sponsor:
University of Arkansas
Collaborator:
Celgene Corporation
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083707
First received: May 27, 2004
Last updated: July 1, 2010
Last verified: July 2010
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Purpose
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 |
|---|---|---|
|
Waldenstrom Macroglobulinemia |
Drug: Thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | UARK 99-006, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia |
Resource links provided by NLM:
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- To determine tumor response, overall and progression free survival following thalidomide therapy in patients with Waldenstrom's Macroglobulinemia (WM)
Secondary Outcome Measures:
- To determine toxicities associated with 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have a confirmed diagnosis of previously treated, active Waldenstrom's Macroglobulinemia
- Patients must have adequate hematologic function as demonstrated by total white blood count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine < or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin < or = 1.5 mg/dl and transaminases < or = 4 x ULN
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria:
- No other concurrent therapy for WM is permitted while on thalidomide
- Pregnant or nursing women may not participate. Before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. Written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083707
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences/MIRT | |
| Little Rock, Arkansas, United States, 72205 | |
Sponsors and Collaborators
University of Arkansas
Celgene Corporation
Investigators
| Principal Investigator: | Athanasios Fassas, M.D. | UAMS |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00083707 History of Changes |
| Other Study ID Numbers: | UARK 99-006 |
| Study First Received: | May 27, 2004 |
| Last Updated: | July 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
Macroglobulinemia Waldenstrom Thalidomide |
Additional relevant MeSH terms:
|
Waldenstrom Macroglobulinemia Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013