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

Graft Versus Host Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

• NCT number: NCT00055666
• Study type: Interventional
• Source: Roswell Park Cancer Institute
• Status: Completed
• Phase: N/A
• Start date: March 2001
• Completion date: April 2006