Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed Ewing's tumor Ewing's sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue High-risk disease (R3), defined as metastases at extrapulmonary/pleural sites Newly diagnosed disease Measurable primary and/or metastatic disease At least one bidimensionally measurable lesion Concurrent enrollment on EURO-Ewing99 clinical trial required PATIENT CHARACTERISTICS: No abnormal cardiac function, including any of the following: Fractional shortening < 29% Ejection fraction < 40% Glomerular filtration rate ≥ 60mL/min Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No prior or current history of chronic diarrhea, bowel obstruction, sub obstruction, Crohn's disease, or ulcerative colitis No other medical, psychiatric, or social condition incompatible with the study treatment PRIOR CONCURRENT THERAPY: No prior chemotherapy No more than 45 days since prior definitive biopsy

Ages Eligible for Study
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Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response as measured by MRI following course 2 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor