Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
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|ClinicalTrials.gov Identifier: NCT00276692|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: irinotecan hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||July 2009|
- Response as measured by MRI following course 2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276692
|Study Chair:||Bruce Morland, MD||Birmingham Children’s Hospital|