Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
NCT ID: NCT00276692
Last Updated: 2013-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2003-08-31
2009-07-31
Brief Summary
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PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with newly diagnosed Ewing's sarcoma.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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irinotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Bruce Morland, MD
Role: STUDY_CHAIR
Birmingham Children's Hospital
Locations
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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
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, 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 Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000454550
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20582
Identifier Type: -
Identifier Source: secondary_id
CCLG-ET-2003-04
Identifier Type: -
Identifier Source: org_study_id
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