PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS

Trial Information

PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS

OBJECTIVES: I. Determine the efficacy of cyclophosphamide, carboplatin, and etoposide in
patients with non-testicular malignant germ cell tumors. II. Improve the quality of life of
these patients by shortening the length of treatment and the extent of initial surgical
resection. III. Determine whether histologic subtypes have prognostic significance. IV.
Determine the efficacy of short term chemotherapy in this patient population. V. Determine
the role of second look surgery in predicting curability of non testicular germ cell tumors.
VI. Determine the role of dose intensification of cyclophosphamide and the introduction of
doxorubicin, methotrexate, and dactinomycin for those patients with partial response, no
response, or progressive disease at the time of second look surgery.

OUTLINE: Patients undergo treatment on Regimen A consisting of surgical resection of tumor
as appropriate for disease followed by chemotherapy with cyclophosphamide IV over 20 minutes
on day 1, carboplatin IV on day 2, and etoposide IV on days 2-4. Patients receive filgrastim
(G-CSF) subcutaneously (SQ) daily beginning 24-48 hours following the last dose of etoposide
and continuing for 14 days or until blood counts recover (a total of 28 days). Chemotherapy
repeats every 3 weeks for 4 courses in the absence of disease progression. At week 11,
patients undergo second look surgery to evaluate response and resect any residual disease.
Patients with no residual disease receive no further therapy. Patients with good partial
response or no response receive salvage chemotherapy on Regimen B. Patients receive salvage
chemotherapy on Regimen B consisting of dactinomycin IV on days 1-3, doxorubicin IV and
vincristine IV continuously on days 1-3, and G-CSF SQ daily beginning 24-48 hours following
last dose of vincristine and continuing for 14 days or until blood counts recover. At week
3, patients receive cyclophosphamide IV on days 1-2, vincristine IV and doxorubicin IV
continuously on days 1-3 and G-CSF as previously given in Regimen B. At week 6, patients
receive methotrexate IV on day 1 and leucovorin calcium orally or IV every 6 hours for 3
days, beginning 16 hours after the completion of methotrexate. At week 8, salvage
chemotherapy repeats for an additional course. Patients achieving complete response
following salvage chemotherapy receive no further therapy. Patients with no response are
removed from study.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study over 6 years.