Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors
Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effect on the body of combining cyclophosphamide with cisplatin, etoposide, and bleomycin in treating children who have newly diagnosed malignant germ cell tumors that are not in the brain and gonads.
OBJECTIVES:
OUTLINE: This is a pilot, multicenter, dose-escalation study of cyclophosphamide.
Cohorts of 6 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are evaluated after 4 courses of therapy. Patients with partial response or stable disease undergo second-look surgery, receive 2 more courses of induction therapy, and are then re-evaluated. Patients who do not achieve complete response (CR) after a total of 6 courses may undergo a third surgery. Patients who still have tumor that cannot be removed are removed from study therapy. Patients who achieve a CR at anytime are followed.
Patients are followed monthly for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study within 1.3 years.
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed extracranial germ cell tumors, including 1 of the following types:
High-risk disease, defined as stage III or IV extragonadal germ cell tumors
Must be enrolled on study within 21 days of diagnostic surgical procedure
PATIENT CHARACTERISTICS:
Age
Performance status
ECOG 0-2
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR
Creatinine based on age as follows:
Pulmonary
FEV_1/FVC greater than 60% OR
Children who are uncooperative must meet all of the following criteria:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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