Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease
Graft Versus Host Disease
About this trial
This is an interventional supportive care trial for Graft Versus Host Disease focused on measuring graft versus host disease
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed graft-vs-host disease (GVHD) with gastrointestinal symptoms Endoscopic evidence of grade II intestinal GVHD without another plausible etiology Confirmed by biopsy of colon, stomach, small intestine, esophagus, or skin within 72 hours prior to study entry At least 10 days post allogeneic hematopoietic stem cell transplantation Received prior anti-candidal prophylaxis of the oropharynx with an effective drug Confirmed absence of intestinal infection within the past 7 days No liver GVHD with bilirubin greater than 3 mg/dL No skin GVHD other than a slowly evolving rash that involves no more than 50% of the body surface No more than 1,000 mL/day of diarrhea on any 1 day within the past 3 days PATIENT CHARACTERISTICS: Age Not specified Performance status Not specified Life expectancy At least 3 months Hematopoietic Not specified Hepatic See Disease Characteristics Renal Not specified Other HIV negative Able to swallow tablets No multi-organ failure No sepsis syndrome No other condition with high mortality No infection of the mouth or esophagus with a fungal organism No persistent vomiting of oral intake Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 30 days since prior biologic agents Chemotherapy Not specified Endocrine therapy At least 30 days since prior systemic (oral or parenteral) prescription corticosteroids administered for prophylaxis or treatment of GVHD or another inflammatory disease process Concurrent dexamethasone as an antiemetic or to lessen side effects during medication or blood product administration allowed Radiotherapy Not specified Surgery See Disease Characteristics Other No prior beclomethasone dipropionate At least 30 days since prior investigational drugs or devices Concurrent immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus, methotrexate, or mycophenolate mofetil) allowed for GVHD prophylaxis
Sites / Locations
- Roswell Park Cancer Institute
- Memorial Sloan-Kettering Cancer Center