NCT00055666

Brief Summary

RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract. PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

3.9 years

First QC Date

March 6, 2003

Last Update Submit

March 7, 2011

Conditions

Graft Versus Host Disease

Keywords

graft versus host disease

Interventions

beclomethasone dipropionateDRUG

Eligibility Criteria

Age4 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract * Failed standard therapy with or has a contraindication to systemic immunosuppressive agents * No clinically significant intestinal infection (confirmed by stool culture) * No persistent vomiting of all oral intake * Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol PATIENT CHARACTERISTICS: Age * 4 to 70 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Able to swallow medication PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * See Disease Characteristics Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Philip L. McCarthy, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2003

First Posted

March 7, 2003

Study Start

March 1, 2001

Primary Completion

February 1, 2005

Study Completion

April 1, 2006

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

US(1)