Thalidomide in Treating Patients With Chronic Graft-Versus-Host Disease Following Bone Marrow Transplant
- Conditions
- Graft Versus Host DiseaseUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00003894
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
RATIONALE: Thalidomide may interfere with the body's ability to recognize transplanted bone marrow cells as foreign and may help treat patients with graft-versus-host disease.
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.
- Detailed Description
OBJECTIVES: I. Determine the efficacy of thalidomide in patients with steroid dependent or refractory chronic graft vs host disease following an allogeneic bone marrow transplant. II. Determine the toxicity of this regimen in these patients.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Louisiana State University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, 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
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States