Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day induction course of prednisone. At study day 10, patients whose symptoms of GVHD are under control undergo a rapid prednisone taper over 7 days, while study drug is continued to study day 50. After discontinuation of study drug at study day 50, patients are followed for 30 additional days, to study day 80. The primary endpoint is treatment failure by day 50, that is, a flare of the symptoms of GVHD that requires immunosuppressive therapy. Secondary endpoints are treatment failure by day 80, treatment-emergent adverse events, and survival at transplant day 200. The hypothesis to be tested is that a topically-active corticosteroid (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone while maintaining control of intestinal GVHD.

Condition or disease	Intervention/treatment	Phase
Graft Vs Host Disease; Gastrointestinal Graft-Versus-Host Disease	Drug: Oral beclomethasone dipropionate (drug)	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	130 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Randomized, Placebo-Controlled, Multi-Center Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal Graft Vs. Host Disease
Study Start Date :	July 2001
Study Completion Date :	December 2004

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Treatment failure (that is, flares of GVHD requiring immunosuppressive drug therapy) at study day 50.

Secondary Outcome Measures :

1. Treatment failure at study day 80.
2. Survival at transplant day 200.
3. Adverse events.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Allogeneic hematopoietic cell transplant ≥10 days prior to screening
• Symptoms consistent with Grade II intestinal GVHD
• Diagnosis of GVHD confirmed by biopsy
• Confirmed absence of intestinal infection
• Demonstrated ability to swallow 2 tablets of the size and configuration of study drug
• Anti-candidal prophylaxis of the oropharynx
• If female and of childbearing potential, willing to use contraception
• Ability to read, understand, and sign informed consent

Exclusion Criteria:

• Skin GVHD other than a slowly evolving skin rash that involves ≤50% of body surface
• Liver GVHD with total serum bilirubin >3 mg/dL
• Negative intestinal biopsy for GVHD
• Systemic prescription corticosteroid use within 30 days
• Persistent vomiting of oral intake the precludes ingestion of study drug tablets
• Multiorgan failure
• Infection of the mouth or esophagus with a fungal organism
• Known HIV seropositivity
• Pregnancy or lactation
• Previous use of BDP tablets, capsules, or inhalation products
• Use of any investigational drug, biologic, or device within 30 days
• Inability to comply with study procedures and scheduled study visits

Contacts and Locations

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Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Enteron Pharmaceuticals

Investigators

Study Director:	Timothy C. Rodell, M.D.	Enteron Pharmaceuticals, Inc., a subsidiary of DOR BioPharma
Study Director:	Scott Cruickshank, Ph.D.	Enteron Pharmaceuticals Inc, a subsidiary of DOR BioPharma

More Information

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Publications of Results:

Hockenbery DM, Cruickshank S, Rodell TC, McDonald GB. A phase 3 randomized, placebo-controlled study of oral beclomethasone 17, 21-dipropionate (BDP) in conjunction with ten days of high-dose prednisone therapy for patients with gastrointestinal graft vs. host disease. Proceedings of the American Association for Cancer Research 45 (Supplement): 109, 2005. Presented at the annual meeting of the American Association for Cancer Research, Anaheim, CA, 2005.

Other Publications:

McDonald GB, Bouvier M, Hockenbery DM, Stern JM, Gooley T, Farrand A, Murakami C, Levine DS. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998 Jul;115(1):28-35.

Baehr PH, Levine DS, Bouvier ME, Hockenbery DM, Gooley TA, Stern JG, Martin PJ, McDonald GB. Oral beclomethasone dipropionate for treatment of human intestinal graft-versus-host disease. Transplantation. 1995 Dec 15;60(11):1231-8.

ClinicalTrials.gov Identifier:	NCT00233896 History of Changes
Other Study ID Numbers:	ENT 00-02
First Posted:	October 6, 2005
Last Update Posted:	October 6, 2005
Last Verified:	December 2004

Keywords provided by Enteron Pharmaceuticals:

Hematopoietic cell transplant; Acute graft-vs.-host disease; Gastrointestinal tract; Randomized trial	Topical corticosteroid; Beclomethasone dipropionate; Prednisone; Survival

Additional relevant MeSH terms:

Graft vs Host Disease; Immune System Diseases; Prednisone; Beclomethasone; Anti-Inflammatory Agents; Glucocorticoids; Hormones	Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anti-Asthmatic Agents; Respiratory System Agents