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A Study of N9 Chemotherapy in Children With Neuroblastoma

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

NCT04947501•Memorial Sloan Kettering Cancer Center

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).

Eligibility

Age

1 - 19 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of NB as defined by histopathology (confirmed by the MSK Department of Pathology), BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
•HR-NB, defined as MYCN-amplified stage 2/3/4/4S at any age and stage 4 in patients \>18 months old.
•No more than one prior cycle of chemotherapy.
•Age \<19 years old.
•Signed informed consent indicating awareness of the investigational nature of this treatment.

Exclusion Criteria

•Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity ≥ grade 3.
•Inability to comply with protocol requirements.
•Pregnancy is not an issue because all patients will be pre-adolescents.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

June 22, 2021

Primary Completion Date

June 22, 2026

Completion Date

June 22, 2026

Last Updated

August 5, 2025

Enrollment

ACTUAL participants

Conditions

NeuroblastomaPediatric Cancer

Interventions

Cyclophosphamide

DRUG

Topotecan

DRUG

Vincristine

DRUG

Doxorubicin

DRUG

Ifosfamide

DRUG

Etoposide

DRUG

Carboplatin

DRUG

Mesna

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of N9 Chemotherapy in Children With Neuroblastoma

Inclusion Criteria

Exclusion Criteria

A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

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Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Familial Investigations of Childhood Cancer Predisposition