Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

Children's Cancer and Leukaemia Group35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoma

Interventions

irinotecan hydrochlorideDRUG

Eligibility

Sex: ALLMax age: 19 Years

Medical Language ↔ Plain English

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

Locations (21)

Our Lady's Hospital for Sick Children Crumlin

Dublin, Ireland

Outcomes

Primary Outcomes

Response as measured by MRI following course 2

Data from ClinicalTrials.gov

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