Status:
COMPLETED
Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Sarcoma
Eligibility:
All Genders
Up to 19 years
Phase:
PHASE2
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...
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, mult...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00276692
Start Date
August 1 2003
End Date
July 1 2009
Last Update
June 26 2013
Active Locations (21)
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1
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
2
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
3
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
4
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ