Breast Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Supportive Care
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