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Spots Global Cancer Trial Database for Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy

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We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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