Clinical Trials Directory

Trials / Completed

CompletedNCT00010283

Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon

Oral Beclomethasone Dipropionate Capsules for Treatment of Intestinal Graft-Versus-Host Disease: Compassionate Use in Patients With Contraindictions to High-Dose Immunosuppressive Therapy

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
—
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
5 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGbeclomethasone dipropionate

Timeline

Start date
2000-07-01
Primary completion
2002-07-01
Completion
2002-07-01
First posted
2004-04-13
Last updated
2010-04-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00010283. Inclusion in this directory is not an endorsement.