RecruitingInterventionalPhase 2

N10: Reduced Therapy for High-Risk Neuroblastoma

NCT ID: NCT06528496Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-02-10

Summary

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

Arms & interventions

BiologicalDANYELZA
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
BiologicalSargramostim
Yeast derived recombinant human Sargramostim (GM-CSF)
DrugCytoxan
Cyclophosphamide is an alkylating agent related to nitrogen mustard
DrugTopotecan
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
DrugVincristine
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
DrugDoxorubicin
Doxorubicin is an anthracycline antibiotic
DrugIfosfamide
Ifosfamide is a structural analogue of cyclophosphamide
DrugEtoposide
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).
DrugCarboplatin
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
DrugIrinotecan
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
DrugTemozolomide
Temozolomide is administered intravenously

Outcome measures

Primary

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

Eligibility criteria

Sex: AllAge: 18 Months to 19 YearsHealthy volunteers: No

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 locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Brian Kushner, MD · Contact

212-639-6793