Trial Information

A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors

OBJECTIVES:

I. Determine whether children with newly diagnosed low- or intermediate-risk extracranial
germ cell tumors (GCTs) can maintain a 3-year event-free survival of at least 92% (for
intermediate-risk tumors only) and overall survival of at least 95% (both low-risk and
intermediate-risk tumors) after treatment with surgery followed by compressed cisplatin,
etoposide, and bleomycin (low-risk disease closed to accrual as of 01/20/10).

II. Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for
whom chemotherapy can be eliminated.

III. Determine the percentage of intermediate-risk patients who require only 3 courses of
therapy.

IV. Determine the acute toxic effects of compressed therapy in these patients. V. Determine
the long-term sequelae in patients treated with this regimen. VI. Determine the number of
hospital days and total drug doses required for patients treated with compressed therapy.

VII. Compare the number of protocol-directed treatment days used in CCG-8882 vs the number
of treatment days used in this study.

VIII. Determine the cytogenetic and molecular genetic features in patients treated with this
regimen.

OUTLINE: Patients are stratified according to disease risk (low vs intermediate).

SURGERY: Patients undergo surgical resection.

Low-risk disease: Patients with gonadal primaries and no evidence of disease after surgery
undergo monitoring for disease progression. Patients who remain disease free receive no
further treatment. Patients who have disease progression after surgery receive compressed
induction chemotherapy. (closed to accrual as of 01/20/2010)

Intermediate-risk disease: After surgery, patients proceed to compressed induction
chemotherapy.

COMPRESSED INDUCTION CHEMOTHERAPY: Patients receive cisplatin IV over 90 minutes and
etoposide IV over 90 minutes on days 1-3 and bleomycin IV over ≥ 10 minutes on day 1.
Treatment repeats every 3 weeks for 3 courses (weeks 0, 3, and 6).

After completion of compressed induction chemotherapy, patients who have no change in
disease status or disease progression are removed from study. Patients with no evidence of
disease receive no further therapy. Patients with a partial response or who have abnormal
tumor markers proceed to second-look surgery and/or 3 more courses of compressed
consolidation chemotherapy.

SECOND-LOOK SURGERY: Patients undergo surgical resection of residual tumor. After surgery,
patients who are in pathologic complete response and have normal tumor markers receive no
further therapy. Patients who remain with a partial response after surgery receive
compressed consolidation chemotherapy.

COMPRESSED CONSOLIDATION CHEMOTHERAPY: Patients receive cisplatin, etoposide, and bleomycin
as in induction chemotherapy in weeks 10, 13, and 16.

Patients are followed up monthly for 6 months, every 3 months for 18 months, and then
annually for up to 10 years.