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Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon Clinical research trials and Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon. Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon clinical trial. Participants frequently obtain the most expert healthcare available for their Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon  Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
For Condition: Leukemia,Multiple Myeloma,Lymphoma,Testicular Cancer,ovarian epithelial cancer,kidney tumor,Breast Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the frequency of treatment success of beclomethasone in patients with intestinal graft-versus-host disease with contraindications to high-dose immunosuppressive therapy. 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. PROTOCOL 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. PROJECTED ACCRUAL: A total of 40-100 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL 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 previous 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 or other immunosuppressive agents, including investigational agents - Chemotherapy: Concurrent cyclosporine, methotrexate, tacrolimus, mycophenolate mofetil, or prednisone allowed if plan in place to taper or discontinue - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified - Other: At least 24 hours since prior drugs that suppress gastric acid secretion (i.e., H2 receptor antagonists or omeprazole); No concurrent drugs that suppress gastric acid secretion --Patient Characteristics-- - Age: Not specified - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Adequate platelet count - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidHockenbery, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Additional Information:
Study ID Numbers: CDR0000068475; FHCRC-1500.00,NCI-H01-0067
Study Start Date: July 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010283
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Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
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