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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00055666

Enrollment

Registered

2003-03-07

Start date

2001-03-31

Completion date

2006-04-30

Last updated

2011-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease

Keywords

graft versus host disease

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.

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.

Interventions

DRUGbeclomethasone dipropionate

Study design

Allocation

NON_RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026