Trial Information

Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

OBJECTIVES:

- Determine the outcome, in terms of local control, event-free survival, and overall
survival, of children with localized unresectable neuroblastoma without MYCN
amplification treated with carboplatin, etoposide, cyclophosphamide, doxorubicin, and
vincristine followed by surgery.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours on days 1-3
(courses 1 and 3). Patients receive cyclophosphamide IV over 1 hour on days 1-5 (or orally
on days 2 and 3), doxorubicin IV over 6 hours on days 4-5, and vincristine IV on days 1 and
5 (courses 2 and 4). Treatment repeats every 21 days for 4 courses. Patients then undergo
surgical resection followed by 2 additional courses of chemotherapy.

Patients are followed at months 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, and 60.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 4 years.