Breast Cancer Clinical Trial
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
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | July 2002 |
Est. primary completion date | July 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 75 Years |
Eligibility |
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 |
Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
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