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Brief Title: Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy
Official Title: High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy
Study ID: NCT00258180
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Name: David M. Loeb, MD, PhD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: PRINCIPAL_INVESTIGATOR
Name: Maria Oliva-Hemker, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: PRINCIPAL_INVESTIGATOR