Trial Information

INTERNATIONAL RANDOMIZED STUDY FOR THE SALVAGE TREATMENT OF GERM CELL TUMOURS

OBJECTIVES: I. Compare the event-free survival of male patients with germ cell tumors in
relapse or first partial remission treated with salvage therapy comprising cisplatin,
etoposide, and ifosfamide (PEI) or vinblastine, ifosfamide, and cisplatin (VeIP) with or
without high-dose carboplatin, etoposide, and cyclophosphamide, followed by autologous bone
marrow and/or peripheral blood stem cell transplantation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
complete remission to first-line treatment (yes vs no), primary site of disease (testicular
vs retroperitoneal vs mediastinal), and lung metastases at study entry (yes vs no).
Autologous bone marrow and peripheral blood stem cells (PBSC) are harvested. Part I
(salvage): Patients are assigned to regimen A if they previously received vinblastine as
part of a first-line treatment, such as cisplatin, vinblastine, and bleomycin (PVB) or
cisplatin, cyclophosphamide, doxorubicin, vinblastine, and bleomycin (CISCA VB). Patients
are assigned to regimen B if they previously received etoposide (VP-16) as part of a
first-line treatment, such as bleomycin, VP-16, and cisplatin (BEP). Regimen A: Patients
receive cisplatin IV over 2 hours, VP-16 IV over 2 hours, and ifosfamide IV over 1 hour on
days 1-5 (PEI). Regimen B: Patients receive cisplatin and etoposide as in regimen A and
vinblastine IV on days 1 and 2 (VeIP). Treatment on both regimens continues every 3 weeks
for 2 courses. Patients with refractory disease at day 43 are taken off study. Part II:
Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive 2 additional
courses of PEI or VeIP. Arm II: Patients receive 1 additional course of PEI or VeIP,
followed by 1 course of high-dose carboplatin IV over 2 hours, VP-16 IV over 2 hours, and
cyclophosphamide IV over 1 hour on days 1-4. Autologous bone marrow and/or PBSC are
reinfused on day 7 of the fourth course for patients on both arms. Patients on both arms
with residual disease after the fourth course may undergo surgery.

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.