Trial Information

European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified

OBJECTIVES:

- Confirm that the management of infants with newly diagnosed stage IV neuroblastoma
without MYCN amplification treated with etoposide and carboplatin and cyclophosphamide,
doxorubicin, and vincristine followed by surgery does not require intensive high-dose
chemotherapy consolidation.

- Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic
factors in these patients.

- Determine whether there are other prognostic criteria that could be used in future
therapeutic stratification of these patients.

OUTLINE: This is a multicenter study.

Patients receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin
IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses.

Patients without disease progression receive 2 additional courses of VP-CARBO chemotherapy.
Patients with metastatic complete response (CR) undergo surgical resection of primary
disease.

Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy receive CADO
chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6
hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days
for 2 courses.

After 2 courses of CADO chemotherapy, patients with metastatic CR undergo surgical resection
of primary disease. Patients with residual disease receive 2 additional courses of CADO
chemotherapy. Patients with residual disease after 4 courses of CADO chemotherapy are
removed from the study. Patients with metastatic CR after additional CADO chemotherapy
undergo surgical resection of primary disease.

Patients are followed within 6 months and then annually for 5 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 4 years.