Sarcoma Clinical Trial
Official title:
Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with
newly diagnosed Ewing's sarcoma.
OBJECTIVES:
Primary
- 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
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