Cyclophosphamide in Treating Young Patients With 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.
|Diarrhea Gastrointestinal Complications Unspecified Childhood Solid Tumor, Protocol Specific||Biological: filgrastim Drug: cyclophosphamide||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy|
- Treatment-free remission at 1 year after study completion
- Toxicities during study treatment
- Effect of treatment on anti-enterocyte antibody titers at 1 year after study completion
|Study Start Date:||June 2005|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258180
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||David M. Loeb, MD, PhD||Sidney Kimmel Comprehensive Cancer Center|
|Principal Investigator:||Maria Oliva-Hemker, MD||Sidney Kimmel Comprehensive Cancer Center|