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Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract



Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

For Condition: Graft Versus Host Disease
Status: Recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract. PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.
Details: OBJECTIVES: - Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids. - Minimize the serious side effects associated with systemic steroid use in these patients. OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year. PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 4 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract - Failed standard therapy with or has a contraindication to systemic immunosuppressive agents - No clinically significant intestinal infection (confirmed by stool culture) - No persistent vomiting of all oral intake - Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol PATIENT CHARACTERISTICS: Age - 4 to 70 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Able to swallow medication PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics Radiotherapy - Not specified Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PhilipMcCarthy,  Study Chair,  Roswell Park Cancer Institute

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Philip  McCarthy 716-845-8707


Additional Information:
Study ID Numbers:
  CDR0000270747;  RPCI-DS-01-04
Study Start Date: 
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055666

Other Graft Versus Host Disease Studies:
1. Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia

2. Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

3. Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment

4. Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia

5. Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma

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Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

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