Overview

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

Status:
Completed
Trial end date:
2002-07-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Beclomethasone may be an effective treatment for graft-versus-host disease. PURPOSE: Phase I/II trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus, stomach, small intestine, or colon.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Beclomethasone
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

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

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