Trial Information

Trial of Chemotherapy Utilizing Carboplatin, Vincristine, Cyclophosphamide and Etoposide for the Treatment of Central Nervous System Primitive Neurectodermal Tumors of Childhood

OBJECTIVES: I. Determine whether chemotherapy utilizing carboplatin, vincristine,
cyclophosphamide, and etoposide improves the prognosis for children with primitive
neuroectodermal tumors of the central nervous system when given after surgery and before
radiotherapy. II. Assess prospective factors that may determine ultimate prognosis in this
patient population. III. Determine the quality of survival of these patients on both
treatment regimens.

OUTLINE: This is a randomized study. Patients undergo surgical removal of the primary tumor.
Following surgery, patients are randomized to receive radiotherapy alone (arm I) or
chemotherapy followed by radiotherapy (arm II). Arm I: Patients begin receiving radiotherapy
as soon as possible after surgery, within 28 days. Radiotherapy is administered 5 times a
week for 6 weeks. Arm II: Within 28 days of surgery, patients receive vincristine IV on days
1, 7, 14, 21, 28, 35, 42, 49, 56, and 63. Carboplatin IV is administered over 1 hour on days
1, 2, 42, and 43. Etoposide IV is administered over 1 hour on days 1-3, 21-23, 42-44, and
63-65. Cyclophosphamide IV is administered over 4 hours on days 21 and 63. As soon as
possible after chemotherapy, patients receive radiotherapy as in arm I. Quality of life is
assessed every 3 months for the first year and annually thereafter. Patients are followed
every 6 weeks for the first year, every 3 months for the second year, every 4 months for the
third year, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
study.