NCT06528496

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

N10: Reduced Therapy for High-Risk Neuroblastoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Months – 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High-risk Neuroblastoma
• Neuroblastoma
• Childhood Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	DANYELZA	DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
BIOLOGICAL	Sargramostim	Yeast derived recombinant human Sargramostim (GM-CSF)
DRUG	Cytoxan	Cyclophosphamide is an alkylating agent related to nitrogen mustard
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).
DRUG	Doxorubicin	Doxorubicin is an anthracycline antibiotic
DRUG	Ifosfamide	Ifosfamide is a structural analogue of cyclophosphamide
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).
DRUG	Carboplatin	Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
DRUG	Irinotecan	Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
DRUG	Temozolomide	Temozolomide is administered intravenously

Timeline

• Start date: 2024-07-22
• Primary completion: 2029-07-22
• Completion: 2029-07-22
• First posted: 2024-07-30
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study