Overview
Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
Status:
Completed
Completed
Trial end date:
2009-07-01
2009-07-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Cancer and Leukaemia GroupTreatments:
Camptothecin
Irinotecan
Criteria
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