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Thalidomide vs. Placebo for Steroid Dependent or Refractory Chronic Graft vs. Host Disease (cGVHD) IND #42782 (NCT00003894)

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.
  • Drug: thalidomide
    Ages eligible for Study
    3 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    10 locations

    United States (10)
    • Arkansas Children's Hospital
      Little Rock, Arkansas, United States, 72202-3591
    • University of Kansas Medical Center
      Kansas City, Kansas, United States, 66160-7357
    • Louisiana State University School of Medicine
      New Orleans, Louisiana, United States, 70112-2822
    • Roswell Park Cancer Institute
      Buffalo, New York, United States, 14263-0001
    • Simmons Cancer Center - Dallas
      Dallas, Texas, United States, 75235-9154
    • Brooke Army Medical Center
      Fort Sam Houston, Texas, United States, 78234
    • Cook Children's Medical Center - Fort Worth
      Fort Worth, Texas, United States, 76104
    • University of Texas - MD Anderson Cancer Center
      Houston, Texas, United States, 77030
    • Cancer Center of the Medical College of Wisconsin
      Milwaukee, Wisconsin, United States, 53226
    • Medical College of Wisconsin
      Milwaukee, Wisconsin, United States, 53226
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    28 February, 1999
    Updated:
    02 March, 2011
    Participants:
    36
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