Thalidomide vs. Placebo for Steroid Dependent or Refractory Chronic Graft vs. Host Disease (cGVHD) IND #42782
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.
Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care
Barbara Jean Bambach, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|Cook Children's Medical Center - Fort Worth||Fort Worth, Texas 76104|
|Arkansas Children's Hospital||Little Rock, Arkansas 72202-3591|
|Louisiana State University School of Medicine||New Orleans, Louisiana 70112-2822|
|Cancer Center of the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|