Trial Information

High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study

OBJECTIVES: I. Evaluate the early efficacy and toxicity profile of high-dose cisplatin,
etoposide, bleomycin, and amifostine in children with newly diagnosed, high-risk malignant,
extragonadal germ cell tumors. II. Determine whether the use of amifostine can reduce the
hematologic and nonhematologic toxic effects of this combination chemotherapy in these
patients when compared to similar patients treated on POG-9049/CCG-8881 with the same
combination chemotherapy. III. Determine the response rate of patients treated with this
regimen.

OUTLINE: Patients undergo surgical biopsy or resection. Patients then receive bleomycin IV
over 10 minutes on day 1 and etoposide IV over 1 hour, amifostine IV over 15 minutes, and
cisplatin IV over 1 hour on days 1-5. Treatment repeats every 3-4 weeks for 4 courses in the
absence of unacceptable toxicity or disease progression. Patients who have no disease after
4 courses of chemotherapy receive no further treatment. Patients who have residual disease
undergo second-look surgery. After surgery, patients who still have active tumor receive 2
additional courses of chemotherapy. Those patients who still have tumor after the 2
additional courses may have a third surgery. Patients are followed every month for 6 months,
every 2 months for 6 months, every 6 months for 1 year, and then annually thereafter until
death.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1.39 years.