13
Participants
Start Date
March 31, 2007
Primary Completion Date
July 31, 2009
Study Completion Date
March 31, 2015
Protracted Oral Etoposide
"Cisplatin with Oral Protracted Etoposide for cycles 1, 2 and 4~Day 1 - 5~* Hour 0: Etoposide 50 mg/m2 po daily~* Hours 1 to 7: Cisplatin 40 mg/m2~Day 6 - 14~* Etoposide 50 mg/m2 po once daily"
Doxorubicin
"Given together with cyclophosphamide for cycle 3 and 5 of induction chemotherapy Day 1 and 2~* Hours 0 to 6: Cyclophosphamide 2000 mg/m2 (67 mg/kg if \< 12 kg) with Mesna 400 mg/m2 (13 mg/kg if \< 12 kg) in D5½NS 600 mL/m2 IV over 6 hours to run at 100 mL/m2/hr~* Hours 6 to 6.25: Doxorubicin 37.5 mg/m2 (1.25 mg/kg if \< 12 kg) IV over 15 minutes"
IV Bolus Etoposide
"Cisplatin with Bolus IV Etoposide~Day 1~Hours 0 to 6: Cisplatin 40 mg/m2~Days 2, 3, 4:~Hours 0 to 1: Etoposide 200 mg/m2 Hours 1 to 7: Cisplatin 40 mg/m2~Day 5:~Hours 0 to 6: Cisplatin 40 mg/m2"
Cisplatin
Cycle 1, 2, and 4
Cyclophosphamide
Cycle 3 and 5 with doxorubicin
Mesna
Standard weight-based dosing with cyclophosphamide
Hematopoietic Factor
Standard weight-based dosing after cycle 3 and 5 and if needed for neutropenic recovery after cycles 1,2 and 4
Primary tumor resection
Resection of primary tumor after cycle 3, 4, or 5 as clinically appropriate
Texas Children's Hospital, Houston
Baylor College of Medicine
OTHER