Thalidomide in Treating Patients With Chronic Graft-Versus-Host Disease Following Bone Marrow Transplant
NCT ID: NCT00003894
Last Updated: 2011-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
1999-03-31
2002-06-30
Brief Summary
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PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating patients who have chronic graft-versus-host disease following bone marrow transplantation.
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Detailed Description
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OUTLINE: This is a randomized study. Patients are stratified according to the type of bone marrow transplant received (allogeneic vs matched unrelated donor) and type of chronic graft vs host disease (steroid dependent vs steroid refractory). Patients receive either oral thalidomide or placebo 2-4 times a day for 6 months. The drug is then tapered until stopped. If disease recurs, the drug may be restarted for a second 6 month course. The maximum duration of treatment is 18 months. Patients continue on steroid therapy, which is tapered during study therapy. If no response is seen after 8 weeks, patients may cross over to the other alternate drug. Patients are followed weekly for 1 month, then every month for 1 year.
PROJECTED ACCRUAL: A total of 36 patients (18 per arm) will be accrued for this study.
Conditions
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Study Design
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PARALLEL
SUPPORTIVE_CARE
Interventions
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thalidomide
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: Not specified
3 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Roswell Park Cancer Institute
Principal Investigators
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Barbara Jean Bambach, MD
Role: STUDY_CHAIR
Roswell Park Cancer Institute
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Louisiana State University School of Medicine
New Orleans, Louisiana, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Cancer Center of the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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RPCI-RP-9809
Identifier Type: -
Identifier Source: secondary_id
CDR0000067064
Identifier Type: -
Identifier Source: org_study_id
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