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

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

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Brian Kushner, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Months

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-22

Primary Completion

2029-07-22

Completion

2029-07-22

FDA Drug

Yes

Countries

• United States

Study Locations