Overview

Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia

Status:
Completed
Trial end date:
2003-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Arkansas
Collaborator:
Celgene Corporation
Treatments:
Thalidomide
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.