Extragonadal Germ Cell Tumor Clinical Trial
Official title:
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:
- Determine the maximum tolerated dose and toxicity profile of cyclophosphamide in
combination with bleomycin, etoposide, and cisplatin in pediatric patients with newly
diagnosed high-risk extracranial, extragonadal malignant germ cell tumors.
- Determine the response rate in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter, dose-escalation study of cyclophosphamide.
- Induction therapy: Patients receive bleomycin IV over 10-20 minutes on day 1, etoposide
IV over 1 hour and cisplatin IV over 4 hours on days 1-5, and cyclophosphamide IV over
1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously once daily
beginning on day 6 and continuing until blood counts recover. Treatment repeats every
21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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