NCT00055666

Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 4 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract. PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.

Detailed description

OBJECTIVES: * Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids. * Minimize the serious side effects associated with systemic steroid use in these patients. OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year. PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	beclomethasone dipropionate

Timeline

• Start date: 2001-03-01
• Primary completion: 2005-02-01
• Completion: 2006-04-01
• First posted: 2003-03-07
• Last updated: 2011-03-08

Locations

1 site across 1 country: United States