Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

March 31, 2015

Conditions
Neuroblastoma
Interventions
DRUG

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"

DRUG

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"

DRUG

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"

DRUG

Cisplatin

Cycle 1, 2, and 4

DRUG

Cyclophosphamide

Cycle 3 and 5 with doxorubicin

DRUG

Mesna

Standard weight-based dosing with cyclophosphamide

DRUG

Hematopoietic Factor

Standard weight-based dosing after cycle 3 and 5 and if needed for neutropenic recovery after cycles 1,2 and 4

PROCEDURE

Primary tumor resection

Resection of primary tumor after cycle 3, 4, or 5 as clinically appropriate

Trial Locations (1)

77030

Texas Children's Hospital, Houston

All Listed Sponsors
lead

Baylor College of Medicine

OTHER

NCT00578864 - Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma | Biotech Hunter | Biotech Hunter