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


Phase 2
3 Years
N/A
Not Enrolling
Both
Graft Versus Host Disease, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed chronic graft vs host disease following
an allogeneic bone marrow transplant (BMT) Greater than 100 days since BMT Must be
receiving at least 1 mg/kg of prednisone or equivalent immunosuppression

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

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care

Principal Investigator

Barbara Jean Bambach, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067064

NCT ID:

NCT00003894

Start Date:

March 1999

Completion Date:

June 2002

Related Keywords:

  • Graft Versus Host Disease
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • unspecified adult solid tumor, protocol specific
  • graft versus host disease
  • Graft vs Host Disease
  • Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Medical College of WisconsinMilwaukee, Wisconsin  53226
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Arkansas Children's HospitalLittle Rock, Arkansas  72202-3591
Louisiana State University School of MedicineNew Orleans, Louisiana  70112-2822
Cancer Center of the Medical College of WisconsinMilwaukee, Wisconsin  53226