Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease
- 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
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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Philip L. McCarthy, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|