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

Phase

Condition

Neuroblastoma

Treatment

Irinotecan

Doxorubicin

Temozolomide

Clinical Study ID

NCT06528496

24-144

Ages 18-19
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosis of NB as defined by histopathology, BM metastases plus high urinecatecholamine 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 thistreatment.

Exclusion

Exclusion Criteria:

Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic,pulmonary, hematologic, or gastrointestinal toxicity >/= to grade 3

°Organ dysfunction due to direct effects of primary tumor or metastatic disease, ordue to paraneoplastic syndromes associated with neuroblastoma, will not beconsidered in exclusion criteria. Similarly, complications of interventions tocontrol above direct effects (e.g., steroid- induced hyperglycemia or hypertension)will also not be considered in exclusion criteria

Inability to comply with protocol requirements
Pregnancy

Study Design