Trial Information

N7: EVALUATION OF MAXIMAL CHEMOTHERAPY DOSE INTENSITY PLUS MONOCLONAL ANTIBODY 3F8 IN THE TREATMENT OF NEUROBLASTOMA

OBJECTIVES: I. Improve the complete remission rate and progression-free survival and reduce
the relapse rate of patients with poor-risk neuroblastoma using intensive multimodality
therapy: cyclophosphamide/doxorubicin/vincristine and cisplatin/etoposide, external-beam
radiotherapy, and surgery (when feasible), followed by radioimmunotherapy with iodine I 131
labeled monoclonal antibody 3F8 followed by autologous bone marrow transplant and
immunotherapy with unlabeled 3F8. II. Identify biologic and clinical prognostic factors that
may guide future modifications in treatment approaches for this malignancy.

OUTLINE: Patients are stratified by prior therapy (yes vs no). Patients undergo surgery
either at diagnosis or after at least 4 courses of chemotherapy, then possibly again after
completion of chemotherapy. Patients receive cyclophosphamide IV over 6 hours on days 1-2,
and doxorubicin IV and vincristine IV over 72 hours on days 1-3 for courses 1, 2, 4, and 6.
Cisplatin IV over 1 hour on days 1-4 and vincristine IV over 2 hours on days 1-3 are
administered as courses 3, 5, and 7. Courses are administered every 16-21 days. Autologous
bone marrow is collected after 3 courses of chemotherapy providing marrow is negative for
tumor cells. Patients undergo radiotherapy after the completion of chemotherapy.
Radiotherapy is administered twice a day for 7 days. Patients then receive iodine I 131
labeled monoclonal antibody 3F8 (MOAB 3F8) on day -5 and again on days 1-5. Autologous bone
marrow is reinfused on day 5 and filgrastim (G-CSF) is administered IV or subcutaneously
beginning day 6. Patients who do not develop HAMA or an allergy to mouse proteins receive
unlabeled MOAB 3F8 IV over 1.5 hours, 5 days a week for 2 weeks. Treatment repeats every 1-2
months for up to 4 courses. Patients are followed every month for 2 years, every 3 months
for 1 year, then annually thereafter.

PROJECTED ACCRUAL: Up to 45 newly diagnosed patients will be accrued for this study within 5
years.