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

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 22, 2024

Primary Completion Date

July 22, 2029

Study Completion Date

July 22, 2029

Conditions
High-risk NeuroblastomaNeuroblastomaChildhood 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

Trial Locations (1)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER