High-Dose Cyclophosphamide for the Treatment of 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Treatment-free remission at 1 year after study completion
No
David M. Loeb, MD, PhD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
J0326, CDR0000441133
NCT00258180
June 2005
January 2009
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |