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OpenTrials
Completed

NCT Number: NCT00055666

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

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.

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Key information

Conditions

Graft Versus Host Disease Graft vs Host Disease Immune System Diseases

Age range

4 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beclomethasone dipropionate

Drug

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease

Important dates

Study start
2001
Primary completion
2005
Study completion
2006
First posted
Mar 7, 2003
Registry last updated
Mar 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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