Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease
4 Years
70 Years
Both
Graft Versus Host Disease
Trial Information
Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
Philip L. McCarthy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000270747
NCT ID:
NCT00055666
Start Date:
March 2001
Completion Date:
April 2006
Related Keywords:
- Graft Versus Host Disease
- graft versus host disease
- Graft vs Host Disease
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
