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.

Condition	Treatment or Intervention	Phase
Leukemia Testicular Cancer ovarian epithelial cancer Lymphoma Breast Cancer Multiple Myeloma kidney tumor	Drug: beclomethasone	Phase I Phase II

Further Study 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.

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

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

Study chairs or principal investigators

David Hockenbery,  Study Chair,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000068475; FHCRC-1500.00; NCI-H01-0067
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010283
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08