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

Alternate Title

Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Supportive care Closed 5 to 75 NCI FHCRC-1500.00 RPCI-DS-99-27, NCI-H01-0067, NCT00010283

Objectives

I. Determine the frequency of treatment success in patients with intestinal 
graft-versus-host disease with contraindications to high-dose 
immunosuppressive therapy treated with beclomethasone.

II. Determine the frequency of adverse events related to the use of this drug 
in these patients.

III. Assess the natural history and outcome of the medical problem for which 
high-dose immunosuppressive therapy was a contraindication.

Entry Criteria

Disease Characteristics:

Histologically proven intestinal (esophagus, stomach, small intestine, or
colon) graft-versus-host disease (GVHD) exhibiting symptoms such as nausea,
vomiting, anorexia, diarrhea, or abdominal pain in the absence of another
explanation for these symptoms

Specific contraindications to high-dose immunosuppressive therapy, such as:
 Recurrent malignant disorder for which an allogeneic antitumor effect is
  desired
 Aspergillus or other fungal infection
 Severe myopathy, hyperglycemia, bone problems, or neuropsychiatric symptoms
  related to corticosteroid use
 Thrombotic thrombocytopenic purpura or hemolytic uremic syndrome related to
  immunosuppressive therapy
 Epstein-Barr virus-related immunoproliferative disease

No GVHD unresponsive to prior high-dose immunosuppressive therapy

No concurrent infections involving the intestinal tract such as:
 Salmonella
 Shigella
 Clostridium difficile (toxin positive)
 Rotavirus
 Giardia lamblia
 Cytomegalovirus by shell vial culture

Prior/Concurrent Therapy:

Biologic therapy:
 At least 7 days since prior anti-thymocyte globulin 

Chemotherapy:
 Concurrent cyclosporine, methotrexate, tacrolimus, mycophenolate mofetil, or
  prednisone allowed if plan in place to taper or discontinue

Endocrine therapy:
 See Disease Characteristics

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 At least 7 days since prior investigational agents
 At least 7 days since prior immunosuppressive agents
 At least 24 hours since prior drugs that suppress gastric acid secretion
  (e.g., H2 receptor antagonists or omeprazole)
 No concurrent drugs that suppress gastric acid secretion

Patient Characteristics:

Age:
 5 to 75

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Platelet count adequate

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 Able to swallow oral capsules
 No persistent vomiting of all oral intake
 No multiorgan failure
 No sepsis syndrome, including positive bacterial or fungal cultures within 72
  hours of study

Expected Enrollment

A total of 40-100 patients will be accrued for this study within 3 years.

Outline

Patients receive oral beclomethasone 4 times daily for 28 days.  Treatment may 
repeat for an additional 28 days as needed.  Patients are interviewed weekly 
to assess treatment success and adverse events.

Patients are followed at 1 and 2 weeks.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

David Hockenbery, MD, Protocol chair		Ph: 206-667-4611

Registry Information
Official Title		Oral Beclomethasone Dipropionate Capsules for Treatment of Intestinal Graft-Versus-Host Disease: Compassionate Use in Patients with Contraindictions to High-Dose Immunosuppressive Therapy
Trial Start Date		2000-07-28
Registered in ClinicalTrials.gov		NCT00010283
Date Submitted to PDQ		2001-01-03
Information Last Verified		2007-07-12
NCI Grant/Contract Number		CA18029, CA15704

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