Overview

Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Cancer and Leukaemia Group
Treatments:
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