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RECRUITING
NCT06528496
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Official title: N10: Reduced Therapy for High-Risk Neuroblastoma

Key Details

Gender

All

Age Range

18 Months - 19 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-07-22

Completion Date

2029-07-22

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States