Trial Information

Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies

OBJECTIVES:

- Determine the response rate of patients with newly diagnosed CNS germ cell tumors
treated with cisplatin and etoposide.

- Determine the survival of patients with CNS germ cell tumors treated with cisplatin and
etoposide followed by cranial radiotherapy.

- Determine endocrine and cognitive function in these patients before and after receiving
this regimen.

OUTLINE: Patients are stratified by histology (germinoma vs nongerminoma).

Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on
days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity. After completion of 4 courses, patients with
nongerminoma who achieve complete response (CR) and all patients with germinoma proceed to
radiotherapy. After completion of 4 courses, patients with nongerminoma who achieve less
than CR undergo resection of any residual cranial masses, if feasible, and then proceed to
radiotherapy. Patients who experience disease progression or unacceptable toxicity during
chemotherapy are restaged and proceed directly to radiotherapy.

Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after
recovering from any toxic effects of chemotherapy, eligible patients undergo a regimen of
craniospinal axis irradiation and/or localized cranial or spinal field irradiation based on
histology, extent of disease, and response to chemotherapy. Patients with gross spinal
meningeal disease after completion of chemotherapy undergo radiotherapy boost.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients with germinoma will be accrued for this study
within 3-6 years. A total of 12-25 patients with nongerminoma will be accrued for this study
within 6-12 years.