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...
Date First Received: March 6, 2003
Last Updated: July 23, 2008
Verified by: National Cancer Institute (NCI), September 2005
Clinical Trial Phase: N/A | Start Date: March 2001
Overall Status: Active, not recruiting
Brief Summary
Official Title: “Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Supportive Care, Open Label
Detailed 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.
Intervention(s) in this Clinical Trial
- Drug: beclomethasone dipropionate
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 4 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Roswell Park Cancer Institute
Overall Clinical Trial Officials and Contacts
Philip L. McCarthy, MD Study Chair Roswell Park Cancer Institute
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00055666
Study ID Number: CDR0000270747
ClinicalTrials.gov Identifier: NCT00055666
Health Authority: United States: Federal Government
Clinical trial summary from the National Cancer Institute's PDQ® database
Clinical Trials Authorship and Review
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