NCT04947501

A Study of N9 Chemotherapy in Children With Neuroblastoma

N9: Pilot Study of Novel Shortened Induction Chemotherapy for High-Risk Neuroblastoma

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 1 Year – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to find out whether N9 is a safe and effective treatment for children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV), Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine (CDV).

Conditions

• Neuroblastoma
• Pediatric Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-22
• Primary completion: 2026-06-22
• Completion: 2026-06-22
• First posted: 2021-07-01
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study