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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055666
• Other study ID #: CDR0000270747
• Secondary ID: RPCI-DS-01-04
• Status: Completed
• Phase: N/A
• First received: March 6, 2003
• Last updated: March 7, 2011
• Start date: March 2001
• Est. completion date: April 2006

Study information

• Verified date: March 2011
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2006
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 70 Years

Eligibility

DISEASE CHARACTERISTICS:

• Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract

• Failed standard therapy with or has a contraindication to systemic immunosuppressive agents

• No clinically significant intestinal infection (confirmed by stool culture)

• No persistent vomiting of all oral intake

• Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol

PATIENT CHARACTERISTICS:

Age

• 4 to 70

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Able to swallow medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

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

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• beclomethasone dipropionate

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States,