eligibility_summary
Eligibility: ≤30y HR NBL/GNBN per INRG/MYCN, on APEC14B1+MCI, BSA ≥0.25 m², limited prior tx allowed (emergent T/C, 1 cycle low/int‑risk, urgent local RT), HIV on effective ART ok, adequate renal (direct GFR/CrCl ≥70 or age‑based Cr), hepatic (bili ≤1.5×ULN, ALT ≤10×ULN[45]), and cardiac (SF ≥27%/EF ≥50%) function, PBSC feasible. Exclude: certain MYCN non‑amp age/stage, marrow failure, chronic immunosuppression, primary immunodeficiency needing IG, pregnancy/lactation, no contraception/consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 3 NCT06172296 tests adding dinutuximab to intensive multimodal therapy for newly diagnosed high‑risk neuroblastoma. Dinutuximab is a chimeric IgG1 monoclonal antibody against GD2 on neuroblastoma cells, it triggers immune killing via ADCC/CDC by NK cells and macrophages. Regimen components and mechanisms: cyclophosphamide, thiotepa, melphalan (alkylators, DNA crosslinking), cisplatin/carboplatin (platinum DNA crosslinkers), topotecan and irinotecan (topoisomerase I inhibitors), etoposide and doxorubicin (topoisomerase II inhibitors, doxorubicin also intercalation/ROS), vincristine (vinca alkaloid, microtubule inhibition), temozolomide (DNA methylator), isotretinoin (retinoid, induces differentiation). Additional modalities: surgery, radiation (DNA breaks), and tandem autologous HSCT. Targets/pathways: GD2+ neuroblastoma cells, DNA replication/repair, mitotic spindle, topoisomerases, and retinoic acid signaling.