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

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06528496

Patient View

This study evaluates the safety and efficacy of N10 chemotherapy in children with high-risk neuroblastoma. Eligible participants must have a confirmed diagnosis, be under 19, and have limited prior chemotherapy. Interventions include monoclonal antibody DANYELZA, Sargramostim, and various chemotherapy drugs like Cyclophosphamide, Topotecan, and Vincristine. Informed consent is required.

Patient Parameters

Program Overview

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

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
  • HR-NB, defined as MYCN-amplified stage L2/M/MS at any age and stage M in patients >18 months old.
  • No more than one prior cycle of HR-NB chemotherapy
  • Age <19 years.
  • Signed informed consent indicating awareness of the investigational nature of this treatment.

Exclusion Criteria

  • Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity > grade 2
  • Inability to comply with protocol requirements
  • Pregnancy

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