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Clinical Trial 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.


Clinical Trial Description

OBJECTIVES: I. Determine the frequency of treatment success in patients with intestinal graft-versus-host disease with contraindications to high-dose immunosuppressive therapy treated with beclomethasone. 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.

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. ;


Study Design

Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Disease
  • Gestational Trophoblastic Tumor
  • Graft Versus Host Disease
  • Graft vs Host Disease
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms, Plasma Cell
  • Neuroblastoma
  • Ovarian Cancer
  • Plasmacytoma
  • Preleukemia
  • Testicular Germ Cell Tumor
  • Testicular Neoplasms
  • Trophoblastic Neoplasms

NCT number NCT00010283
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2000
Completion date July 2002

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