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NCT Number: NCT06528496

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

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Key information

Conditions

High-risk Neuroblastoma Childhood Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

18 month–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Brian Kushner, MD

CONTACT

212-639-6793

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DANYELZA

Biological

DANYELZA is a humanized monoclonal antibody of the IgG1 subclass

Other names: Naxitamab

sargramostim

Biological

Yeast derived recombinant human Sargramostim (GM-CSF)

Other names: granulocyte-macrophage colony-stimulating factor, GM-CSF

Cytoxan

Drug

Cyclophosphamide is an alkylating agent related to nitrogen mustard

Other names: Cyclophosphamide

Topotecan

Drug

Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.

Vincristine

Drug

Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).

Other names: Oncovin

Doxorubicin

Drug

Doxorubicin is an anthracycline antibiotic

Other names: Adriamycin

ifosfamide

Drug

Ifosfamide is a structural analogue of cyclophosphamide

Other names: Isophosphamide

etoposide

Drug

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: VePesid, Etopophos, VP-16

carboplatin

Drug

Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.

Other names: Paraplatin

Irinotecan

Drug

Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor

Other names: Camptosar

Temozolomide

Drug

Temozolomide is administered intravenously

Other names: Temodar

radiation therapy

Radiation

Between first and second cycle of antibody

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Kushner, MD

CONTACT

[email protected]

8336755491

Fiorella Iglasias Cardenas, MD, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

N10: Reduced Therapy for High-Risk Neuroblastoma

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 30, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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