Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease.
PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.
|Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Graft Versus Host Disease Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor||Drug: beclomethasone dipropionate||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||Oral Beclomethasone Dipropionate Capsules for Treatment of Intestinal Graft-Versus-Host Disease: Compassionate Use in Patients With Contraindictions to High-Dose Immunosuppressive Therapy|
|Study Start Date:||July 2000|
|Study Completion Date:||July 2002|
|Primary Completion Date:||July 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the frequency of treatment success in patients with intestinal graft-versus-host disease with contraindications to high-dose immunosuppressive therapy treated with beclomethasone. II. Determine the frequency of adverse events related to the use of this drug in these patients. III. Assess the natural history and outcome of the medical problem for which high-dose immunosuppressive therapy was a contraindication.
OUTLINE: Patients receive oral beclomethasone 4 times daily for 28 days. Treatment may repeat for an additional 28 days as needed. Patients are interviewed weekly to assess treatment success and adverse events. Patients are followed at 1 and 2 weeks.
PROJECTED ACCRUAL: A total of 40-100 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010283
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||David Hockenbery, MD||Fred Hutchinson Cancer Research Center|