Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia
Completed · Phase 2
Conditions studied: Waldenstrom Macroglobulinemia
In brief
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.
Key facts
- Study ID
- NCT00083707
- Run by
- University of Arkansas
- People needed
- 40
- Starts
- 1999-01-01
- Expected to finish
- 2003-02-01
- Last updated by the study team
- 2010-07-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Arkansas for Medical Sciences/MIRT — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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