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

Primary Purpose

Graft Versus Host Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
beclomethasone dipropionate
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Graft Versus Host Disease focused on measuring graft versus host disease

Eligibility Criteria

4 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 6, 2003
Last Updated
March 7, 2011
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00055666
Brief Title
Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract
Official Title
Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
Keywords
graft versus host disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
beclomethasone dipropionate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip L. McCarthy, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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