NCT00043147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2002

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

May 30, 2013

Status Verified

December 1, 2004

First QC Date

August 5, 2002

Last Update Submit

May 29, 2013

Conditions

Graft Versus Host Disease

Keywords

graft versus host disease

Interventions

beclomethasone dipropionateDRUG
methylprednisoloneDRUG
prednisoneDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

BeclomethasoneMethylprednisolonePrednisone

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, ChlorinatedPrednisolonePregnadienediols

Study Officials

  • Miguel-Angel Perales, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Study Completion

January 1, 2005

Last Updated

May 30, 2013

Record last verified: 2004-12

Locations

US(2)