Trial Information

Study Of Reduced Dose Craniospinal Radiotherapy (1800 cGy) And Chemotherapy In Children With Newly-Diagnosed Standard-Risk Posterior Fossa Primitive Neuro-ectodermal Tumor (PNET/Medulloblastoma)

OBJECTIVES:

- Reduce the late cognitive, auditory, and endocrinologic effects in children with newly
diagnosed standard-risk posterior fossa primitive neuroectodermal tumor or
medulloblastoma by reducing the adjuvant craniospinal radiotherapy dose by 25%, but
maintaining a therapeutic efficacy (86% 3-year relapse-free survival) of current
standard therapy by using maintenance chemotherapy comprising lomustine, cisplatin, and
vincristine alternated with cyclophosphamide and etoposide.

- Evaluate the acute and subacute toxicity of this regimen in these patients.

- Evaluate the late neurotoxic effects of low-dose craniospinal radiotherapy, in terms of
cognitive, endocrinologic, and auditory function, in these patients.

OUTLINE: This is a multicenter study.

- Adjuvant induction chemoradiotherapy: Beginning within 28 days after prior resection,
patients undergo radiotherapy to the craniospinal axis 5 days a week for 2 weeks and
then conformal radiotherapy to the tumor bed 5 days a week for 4 weeks. Beginning 1
week after the initiation of radiotherapy, patients receive vincristine IV weekly for 6
weeks.

- Maintenance chemotherapy: Beginning 4 weeks after the completion of induction
chemoradiotherapy, patients receive two 6-week courses of regimen A as outlined below
alternated with one 6-week course of regimen B as outlined below for a total of 9
courses (6 courses of regimen A and 3 courses of regimen B).

- Regimen A: Patients receive oral lomustine and cisplatin IV over 8 hours on day 0
and vincristine IV on days 0, 7, and 14.

- Regimen B: Patients receive cyclophosphamide IV on days 0 and 1 and etoposide IV
on days 0 and 1 and then orally on days 14-34.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 3 years.