Trial Information

A Study Of The Treatment Of Metastatic Neuroblastoma In Children More Than One Year Of Age At Diagnosis

OBJECTIVES:

- Determine the efficacy of induction chemotherapy followed by surgical resection and
consolidation chemotherapy with autologous peripheral blood stem cell transplantation
in patients with metastatic neuroblastoma.

- Determine the tolerability and feasibility of this regimen in these patients.

- Determine the medium and long-term results in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days
1 and 2 and doxorubicin IV continuously and vincristine IV continuously over days 1-3 of
courses 1, 2, 4, and 6. Patients receive cisplatin IV over 1 hour on days 1-4 and etoposide
IV over 2 hours on days 1-3 of induction courses 3, 5, and 7. Patients also receive
filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 5 of courses 3, 5, and 7
and continuing until blood counts recover. Treatment repeats every 21 days.

At the completion of induction chemotherapy, patients undergo surgical resection. Patients
in complete remission receive high-dose consolidation chemotherapy comprising oral busulfan
every 6 hours on days -7 to -3 and melphalan IV over 2 minutes on day -2. Autologous
peripheral blood stem cells (PBSC) are reinfused on day 0. Patients with n-myc tumor
amplification undergo radiotherapy at least 70 days after PBSC transplantation.

Patients are followed every 6 months.

PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.