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

Conditions

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

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

Experimental: Participants with Neuroblastoma
Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.

Evaluate participant response [ Time Frame: After 2 cycles of mAb-based therapy (each cycle is 21 days) ]

Facility	City	State	ZIP	Site coordinators
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Brian Kushner, MD 212-639-6793

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