Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Beclomethasone combined with prednisone may be an effective treatment for graft-versus-host disease caused by stem cell transplantation. It is not yet known if prednisone is more effective with or without beclomethasone in treating gastrointestinal graft-versus-host disease.

PURPOSE: Randomized phase III trial to determine the effectiveness of prednisone with or without beclomethasone in treating patients who have graft-versus-host disease afftecting the gastrointestinal system.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Beclomethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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