N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma

February 9, 2026 updated by: Memorial Sloan Kettering Cancer Center

N10: Reduced Therapy for High-Risk Neuroblastoma

The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Brian Kushner, MD
          • Phone Number: 212-639-6793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
  • HR-NB, defined as MYCN-amplified stage L2/M/MS at any age and stage M in patients >18 months old.
  • No more than one prior cycle of HR-NB chemotherapy
  • Age <19 years.
  • 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 >/= to grade 3

    °Organ dysfunction due to direct effects of primary tumor or metastatic disease, or due to paraneoplastic syndromes associated with neuroblastoma, will not be considered in exclusion criteria. Similarly, complications of interventions to control above direct effects (e.g., steroid- induced hyperglycemia or hypertension) will also not be considered in exclusion criteria

  • Inability to comply with protocol requirements
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with Neuroblastoma
Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Biological: DANYELZA
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
Other Names:
  • Naxitamab
Biological: Sargramostim
Yeast derived recombinant human Sargramostim (GM-CSF)
Other Names:
  • GM-CSF
  • granulocyte-macrophage colony-stimulating factor
Drug: Cytoxan
Cyclophosphamide is an alkylating agent related to nitrogen mustard
Other Names:
  • Cyclophosphamide
Drug: Topotecan
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
Drug: Vincristine
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
Other Names:
  • Oncovin
Drug: Doxorubicin
Doxorubicin is an anthracycline antibiotic
Other Names:
  • Adriamycin
Drug: Ifosfamide
Ifosfamide is a structural analogue of cyclophosphamide
Other Names:
  • Isophosphamide
Drug: Etoposide
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).
Other Names:
  • VP-16
  • Etopophos
  • VePesid
Drug: Carboplatin
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
Other Names:
  • Paraplatin
Drug: Irinotecan
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
Other Names:
  • Camptosar
Drug: Temozolomide
Temozolomide is administered intravenously
Other Names:
  • Temodar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate participant response
Time Frame: After 2 cycles of mAb-based therapy (each cycle is 21 days)
To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients.
After 2 cycles of mAb-based therapy (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Brian Kushner, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Estimated)

July 22, 2029

Study Completion (Estimated)

July 22, 2029

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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