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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00043147 |
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.
Condition | Intervention | Phase |
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Graft Versus Host Disease |
Drug: beclomethasone dipropionate Drug: methylprednisolone Drug: prednisone |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
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 Prednisone Therapy in the Treatment of Patients With Grade II Graft vs. Host Disease With Gastrointestinal Symptoms |
Study Start Date: | April 2002 |
OBJECTIVES:
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.
In both arms, treatment continues in the absence of poorly controlled GVHD at day 10 or unacceptable toxicity.
Patients are followed at days 51, 60, and 80 and then at 200 days post-transplantation.
PROJECTED ACCRUAL: A total of 130 patients (65 per treatment arm) will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed graft-vs-host disease (GVHD) with gastrointestinal symptoms
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Miguel-Angel Perales, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000256305, MSKCC-01149, ENTERON-00-02, NCI-G02-2098, RPCI-DS-01-09 |
Study First Received: | August 5, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00043147 |
Health Authority: | United States: Federal Government |
graft versus host disease |
Prednisone Methylprednisolone Graft versus host disease Prednisolone Methylprednisolone acetate |
Beclomethasone Graft vs Host Disease Prednisolone acetate Methylprednisolone Hemisuccinate Homologous wasting disease |
Anti-Inflammatory Agents Respiratory System Agents Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Antiemetics |
Protective Agents Neuroprotective Agents Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |