NCT00258180

Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy

High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diarrhea
• Gastrointestinal Complications
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
DRUG	cyclophosphamide	Administered IV over 1 hour on days 1-4

Timeline

• Start date: 2005-08-15
• Primary completion: 2009-02-24
• Completion: 2009-02-24
• First posted: 2005-11-24
• Last updated: 2019-04-16
• Results posted: 2019-04-16

Locations

1 site across 1 country: United States