Sarcoma
Conditions
Keywords
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
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.
Interventions
DRUGirinotecan hydrochloride
Sponsors
Children's Cancer and Leukaemia Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response as measured by MRI following course 2 | — |
Countries
Ireland, United Kingdom
Outcome results
None listed