drugset
drugset / Trial / NCT00066482

Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors

NCT00066482 ↗

Completed 19 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2004-07
Primary completion
2007-04
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 40 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 80 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 1.2 g Intravenous
Subject Cyclophosphamide Other / unclassified 1.8 g Intravenous
Subject Cyclophosphamide Other / unclassified 2.4 g Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule — Intravenous
Background Bleomycin Unknown 0.5 iu/kg Intravenous
Background Bleomycin Unknown 15 iu Intravenous
Background Cisplatin Other / unclassified 0.67 mg/kg Intravenous
Background Cisplatin Other / unclassified 20 mg/m2 Intravenous
Background Etoposide Small molecule 3.3 mg/kg Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications

childhood germ cell tumor extragonadal germ cell tumor