Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

Phase 2

Completed

• Conditions: Sarcoma

• Registration Number: NCT00276692
• Lead Sponsor: Children's Cancer and Leukaemia Group

Brief Summary

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

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 Timeline

• Study Start: 2003-08
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Primary Completion: 2008-09
• Status Verified: 2009-06
• Study Completion: 2009-07
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response as measured by MRI following course 2

Trial Locations

Locations (20)

Our Lady's Hospital for Sick Children Crumlin; 🇮🇪 Dublin, Ireland

Birmingham Children's Hospital; 🇬🇧 Birmingham, England, United Kingdom

Institute of Child Health at University of Bristol; 🇬🇧 Bristol, England, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey; 🇬🇧 Liverpool, England, United Kingdom

Royal London Hospital; 🇬🇧 London, England, United Kingdom

Great Ormond Street Hospital for Children; 🇬🇧 London, England, United Kingdom

Royal Manchester Children's Hospital; 🇬🇧 Manchester, England, United Kingdom

Scroll for more (10 remaining)