A Study of N9 Chemotherapy in Children With Neuroblastoma

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

June 22, 2021

Primary Completion Date

June 22, 2026

Study Completion Date

June 22, 2026

Conditions
NeuroblastomaPediatric Cancer
Interventions
DRUG

Cyclophosphamide

"Administration of CTV - cycles 1 and 4~Days 1 \& 2: Cyclophosphamide 70 mg/kg/day (2100 mg/m2/day for patients \>10 years old), IV over 6 hrs.~Mesna 70 mg/kg (2100 mg/m2/day for patients \>10 years old) , by 24-hr IV infusion, starting with the cyclophosphamide infusion.~Days 1-4: Topotecan 2 mg/m2/day, IV over 30 minutes. Day 1: Vincristine 0.067 mg/kg (or 2 mg/m2, whichever is less) by IV piggyback; maximum dose is 2 mg.~\*\*\*\*\*\*\* Administration of CDV - cycle 3 Days 1 \& 2: Cyclophosphamide 70 mg/kg/day ((2100 mg/m2/day for patients \>10 years old), IV over 6 hrs.~Mesna 70 mg/kg ((2100 mg/m2/day for patients \>10 years old), by 24-hr IV infusion, starting with the cyclophosphamide infusion.~Days 1-3: Doxorubicin 25 mg/m2/day, by 24-hr IV infusion (total dose over 72 hr is 75 mg/m2).~Days 1-3: Vincristine 0.67 mg/m2/day or 0.022 mg/kg/day (whichever is less), by 24-hr IV infusion (total dose over 72 hr is 2 mg/m2 or 0.067 mg/kg); maximum dose is 0.67 mg/day, or 2mg over 72 hr."

DRUG

Topotecan

"Administration of CTV - cycles 1 and 4~Days 1 \& 2: Cyclophosphamide 70 mg/kg/day (2100 mg/m2/day for patients \>10 years old), IV over 6 hrs.~Mesna 70 mg/kg (2100 mg/m2/day for patients \>10 years old) , by 24-hr IV infusion, starting with the cyclophosphamide infusion.~Days 1-4: Topotecan 2 mg/m2/day, IV over 30 minutes. Day 1: Vincristine 0.067 mg/kg (or 2 mg/m2, whichever is less) by IV piggyback; maximum dose is 2 mg."

DRUG

Vincristine

"Administration of CTV - cycles 1 and 4~Days 1 \& 2: Cyclophosphamide 70 mg/kg/day (2100 mg/m2/day for patients \>10 years old), IV over 6 hrs.~Mesna 70 mg/kg (2100 mg/m2/day for patients \>10 years old) , by 24-hr IV infusion, starting with the cyclophosphamide infusion.~Days 1-4: Topotecan 2 mg/m2/day, IV over 30 minutes. Day 1: Vincristine 0.067 mg/kg (or 2 mg/m2, whichever is less) by IV piggyback; maximum dose is 2 mg."

DRUG

Doxorubicin

"Administration of CDV - cycle 3 Days 1 \& 2: Cyclophosphamide 70 mg/kg/day ((2100 mg/m2/day for patients \>10 years old), IV over 6 hrs.~Mesna 70 mg/kg ((2100 mg/m2/day for patients \>10 years old), by 24-hr IV infusion, starting with the cyclophosphamide infusion.~Days 1-3: Doxorubicin 25 mg/m2/day, by 24-hr IV infusion (total dose over 72 hr is 75 mg/m2).~Days 1-3: Vincristine 0.67 mg/m2/day or 0.022 mg/kg/day (whichever is less), by 24-hr IV infusion (total dose over 72 hr is 2 mg/m2 or 0.067 mg/kg); maximum dose is 0.67 mg/day, or 2mg over 72 hr."

DRUG

Ifosfamide

Administration of ICE - cycle 2 Days 1-5: Ifosfamide 1500 mg/m2/day (50 mg/kg/day if weight is \<10 kg), IV over 6 hrs. Mesna 1500 mg/m2/day, by 24-hr IV infusion, starting with the ifosfamide infusion. Days 1-2: Carboplatin 400 mg/m2/day (13.3 mg/kg/day if weight is \<10 kg), IV over 1 hr. Days 1-5: Etoposide 100 mg/m2/day (3.3. mg/kg/day if weight is \<10 kg), IV over 2 hrs.

DRUG

Etoposide

"Administration of ICE - cycle 2~Days 1-5: Ifosfamide 1500 mg/m2/day (50 mg/kg/day if weight is \<10 kg), IV over 6 hrs. Mesna 1500 mg/m2/day, by 24-hr IV infusion, starting with the ifosfamide infusion. Days 1-2: Carboplatin 400 mg/m2/day (13.3 mg/kg/day if weight is \<10 kg), IV over 1 hr. Days 1-5: Etoposide 100 mg/m2/day (3.3. mg/kg/day if weight is \<10 kg), IV over 2 hrs."

DRUG

Carboplatin

"Administration of ICE - cycle 2~Days 1-5: Ifosfamide 1500 mg/m2/day (50 mg/kg/day if weight is \<10 kg), IV over 6 hrs. Mesna 1500 mg/m2/day, by 24-hr IV infusion, starting with the ifosfamide infusion. Days 1-2: Carboplatin 400 mg/m2/day (13.3 mg/kg/day if weight is \<10 kg), IV over 1 hr. Days 1-5: Etoposide 100 mg/m2/day (3.3. mg/kg/day if weight is \<10 kg), IV over 2 hrs."

DRUG

Mesna

"Administration of CTV - cycles 1 and 4 Mesna 70 mg/kg (2100 mg/m2/day for patients \>10 years old) , by 24-hr IV infusion, starting with the cyclophosphamide infusion.~Administration of ICE - cycle 2 Mesna 1500 mg/m2/day, by 24-hr IV infusion, starting with the ifosfamide infusion.~Administration of CDV - cycle 3 Mesna 70 mg/kg ((2100 mg/m2/day for patients \>10 years old), by 24-hr IV infusion, starting with the cyclophosphamide infusion."

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER