Clinical Trial: Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose
Brief 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.
Detailed Summary:
OBJECTIVES:
- Compare the efficacy of beclomethasone dipropionate and prednisone vs placebo and prednisone, in terms of time to treatment failure, in patients with grade II graft-vs-host disease with gastrointestinal symptoms.
- Compare the proportion of treatment failures on study days 10, 30, 50, 60, and 80 in patients treated with these regimens.
- Compare the cumulative systemic corticosteroid exposure in patients treated with these regimens.
- Compare the incidence and degree of hypothalamic-pituitary-adrenal axis suppression in patients treated with these regimens who have not experienced treatment failure by study day 50.
- Compare the safety of these regimens in these patients.
- Compare the total deaths and causes of death through 200 days post-transplantation of patients treated with these regimens.
- Assess the pharmacokinetic profile of beclomethasone dipropionate in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel, multicenter study. Patients are stratified according to graft tissue source (2 HLA haplotype-identical sibling vs all others) and topical steroid use at baseline (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral beclomethasone dipropionate 4 times daily on days 1-50. Patients also receive oral prednisone (or methylprednisolone IV) twice daily on days 1-10 with a rapid taper on days 11-17 followed by low-dose prednisone on days 18-80.
- Arm II: Patients receive oral placebo 4
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: August 5, 2002
Date Started: April 2002
Date Completion:
Last Updated: May 29, 2013
Last Verified: December 2004