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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055666
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : March 8, 2011
Information provided by:
Roswell Park Cancer Institute

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
Graft Versus Host Disease Drug: beclomethasone dipropionate Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2001
Actual Primary Completion Date : February 2005
Actual Study Completion Date : April 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 4 to 70

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Able to swallow medication


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • See Disease Characteristics


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055666

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Study Chair: Philip L. McCarthy, MD Roswell Park Cancer Institute

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Responsible Party: Philip McCarthy,, Roswell Park Cancer Institute Identifier: NCT00055666     History of Changes
Other Study ID Numbers: CDR0000270747
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011
Keywords provided by Roswell Park Cancer Institute:
graft versus host disease
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents