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


N/A
4 Years
70 Years
Not Enrolling
Both
Graft Versus Host Disease

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Philip L. McCarthy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000270747

NCT ID:

NCT00055666

Start Date:

March 2001

Completion Date:

April 2006

Related Keywords:

  • Graft Versus Host Disease
  • graft versus host disease
  • Graft vs Host Disease

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263