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

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00055666
First received: March 6, 2003
Last updated: March 7, 2011
Last verified: March 2011
History of Changes

March 6, 2003
March 7, 2011
March 2001
February 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00055666 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract
Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease

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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Graft Versus Host Disease
Drug: beclomethasone dipropionate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
April 2006
February 2005   (final data collection date for primary outcome measure)

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
Both
4 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00055666
CDR0000270747, RPCI-DS-01-04
Yes
Philip McCarthy,, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Study Chair: Philip L. McCarthy, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP