Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Institute of Child Health at University of Bristol
🇬🇧Bristol, England, United Kingdom
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
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 London Hospital
🇬🇧London, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Aberdeen Children's Hospital
🇬🇧Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
🇬🇧Cardiff, Wales, United Kingdom
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom