Diarrhea Clinical Trial
Official title:
High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy
RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .
PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young
patients with severe autoimmune enteropathy.
OBJECTIVES:
Primary
- Determine the rate of treatment-free remission in young patients with severe autoimmune
enteropathy treated with high-dose cyclophosphamide.
Secondary
- Determine the toxic effects of this drug in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive
filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3
days or until blood counts recover.
After completion of study treatment, patients are followed periodically for up to 1½ years.
PROJECTED ACCRUAL: A total of 7-11 patients will be accrued for this study.
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