A Phase 2 interventional study of irinotecan hydrochloride in Sarcoma, sponsored by Children's Cancer and Leukaemia Group. Completed at 21 sites in 2 countries. Open to participants aged Up to 19 Years. Per ClinicalTrials.gov, last updated 2013-06-26.
Sponsored by Children's Cancer and Leukaemia Group · Phase 2, Interventional, and Treatment
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
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 35 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Children's Cancer and Leukaemia Group is the lead sponsor of 44 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed Ewing's tumor
Measurable primary and/or metastatic disease
PATIENT CHARACTERISTICS:
No abnormal cardiac function, including any of the following:
PRIOR CONCURRENT THERAPY:
Response as measured by MRI following course 2
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Children's Cancer and Leukaemia Group