A Study of N9 Chemotherapy in Children With Neuroblastoma

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

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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Brian Kushner, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-22

Primary Completion

2026-06-22

Completion

2026-06-22

FDA Drug

Yes

Countries

• United States

Study Locations