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Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00055666
Collaborator
(none)
51
Enrollment
1
Location
61
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: beclomethasone dipropionate
 N/A

Detailed Description

OBJECTIVES:

  • Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids.

  • Minimize the serious side effects associated with systemic steroid use in these patients.

OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year.

PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease
Study Start Date :
Mar 1, 2001
Actual Primary Completion Date :
Feb 1, 2005
Actual Study Completion Date :
Apr 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263-0001

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Study Chair: Philip L. McCarthy, MD, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00055666
    Other Study ID Numbers:
    • CDR0000270747
    • RPCI-DS-01-04
    First Posted:
    Mar 7, 2003
    Last Update Posted:
    Mar 8, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    graft versus host disease
    Additional relevant MeSH terms:
    Graft vs Host Disease
    Beclomethasone

    Study Results

    No Results Posted as of Mar 8, 2011