Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma
- Assess the responsiveness of single-agent irinotecan hydrochloride in a patient
population with newly diagnosed high-risk Ewing's sarcoma.
OUTLINE: This is an open-label, multicenter study.
Patients receive irinotecan hydrochloride IV over 1 hour on day 1. Treatment repeats every
21 days for 2 courses. After completion of 2 courses of therapy, patients may receive
additional treatment at the discretion of the treating physician.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Response as measured by MRI following course 2
Bruce Morland, MD
Birmingham Children's Hospital
United States: Federal Government