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Reduced Chemotherapy and Monoclonal Antibody Therapy for High-Risk Neuroblastoma

This study is looking into a treatment called N10 for children with high-risk neuroblastoma, a type of cancer that starts in nerve cells. The N10 treatment uses a combination of medicines: DANYELZA (a monoclonal antibody, which is a type of protein that can target cancer cells), Sargramostim, Cytoxan, Topotecan, and Vincristine. Researchers want to see if this treatment is safe and works well. You might be able to join if you are between 18 months and 19 years old, have high-risk neuroblastoma, and have not had much chemotherapy before. The main goal is to see how well participants respond to the treatment after two cycles of the DANYELZA-based therapy. The current status of this study is unclear, and it plans to enroll 45 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 45 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participant response will be evaluated after two 21-day cycles of the monoclonal antibody-based therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06528496

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

Recruiting
PHASE2Ages 18–19InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~45 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:DANYELZASargramostimCytoxanTopotecanVincristineDoxorubicin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate participant response
Measured over After 2 cycles of mAb-based therapy (each cycle is 21 days)

Conditions

High-risk Neuroblastoma
Neuroblastoma
Childhood Neuroblastoma

Explore related trials

NeuroblastomaMYCN Gene

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Brian Kushner, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Brian Kushner, MD
[email protected]
8336755491
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity \>/= to grade 3
Inability to comply with protocol requirements
Pregnancy

What this trial measures

  • Evaluate participant responseAfter 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.