Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia
Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Waldenstrom Macroglobulinemia
Intervention: Thalidomide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Arkansas Official(s) and/or principal investigator(s): Athanasios Fassas, M.D., Principal Investigator, Affiliation: UAMS
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.
Clinical Details
Official title: UARK 99-006, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine tumor response, overall and progression free survival following thalidomide therapy in patients with Waldenstrom's Macroglobulinemia (WM)
Secondary outcome: To determine toxicities associated with thalidomide in patients with Waldenstrom's Macroglobulinemia
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas 72205, United States
Additional Information
Myeloma Institute for Research & Therapy website
Starting date: January 1999
Last updated: July 1, 2010
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