eligibility_summary
Include: Neuroblastoma by histology, BM+ with high urine catecholamines, or MIBG+. High-risk: MYCN-amplified stage L2/M/MS (any age) or stage M >18 months. ≤1 prior HR-NB chemo. Age <19. Consent. Exclude: grade ≥3 major organ toxicity (renal/cardiac/hepatic/neurologic/pulmonary/hematologic/GI) unless due to tumor/paraneoplastic/intervention, inability to comply, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 2 (MSK N10) for high‑risk pediatric neuroblastoma tests reduced chemotherapy plus mAb‑based immunotherapy. Immunotherapy: DANYELZA (naxitamab), a humanized IgG1 anti‑GD2 monoclonal antibody that binds GD2 on neuroblastoma cells and mediates ADCC and complement cytotoxicity, Sargramostim (GM‑CSF), a cytokine that expands/activates myeloid cells to enhance ADCC. Chemotherapy: cyclophosphamide, ifosfamide (alkylators), temozolomide (DNA‑methylating alkylator), carboplatin (platinum crosslinker), doxorubicin (anthracycline, DNA intercalation/topo II inhibition/ROS), etoposide (topo II inhibitor), topotecan, irinotecan (topo I inhibitors), vincristine (vinca alkaloid, microtubule inhibitor). Targets/pathways: GD2 on tumor, effector granulocytes/macrophages/NK cells and complement, DNA damage/crosslinking, topoisomerases I/II, microtubules.