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Compassionate Use of Oral Beclomethasone in Patients With Gastrointestinal Graft-Versus-Host Disease

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Supportive care Closed 4 to 70 NCI RPCI-DS-01-04
NCT00055666

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

See Disease Characteristics

Radiotherapy

Not specified

Surgery

Not specified

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

Expected Enrollment

A total of 24-45 patients will be accrued for this study within 3 years.

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Philip McCarthy, MD, Protocol chair
Ph: 716-845-4074; 800-685-6825
Email: philip.mccarthy@roswellpark.org

Registry Information

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

Trial Start Date		2001-03-27

Registered in ClinicalTrials.gov		NCT00055666

Date Submitted to PDQ		2003-01-07

Information Last Verified		2005-09-08

NCI Grant/Contract Number		CA16056

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.