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Standard vs high-dose chemotherapy with craniospinal irradiation in pediatric metastatic medulloblastoma and other embryonal tumours
2024-518964-11-01Phase 2Authorised
- Sponsor
- Meyer Children's Hospital IRCCS
- Start
- Jan 2025
- Modality
- Small Molecules, Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
- Countries
- 1
01
Overview
Phase 2, open-label, single-arm trial of methotrexate, carboplatin, lomustine, cyclophosphamide, etoposide and 2 more in medulloblastoma, embryonal tumor and pineoblastoma (PB), sponsored by Meyer Children's Hospital IRCCS. Primary endpoints: Percentage of subjects with new neurological symptoms ≥ Grade 3 not present at baseline and not related to recurrence/progression, Percentage of subjects with serious adverse events (SAE) and 2 more. Planned start Jan 2025; status: authorised.
02
Drugs
methotrexatecarboplatinlomustinecyclophosphamideetoposide
03
Conditions
medulloblastomaembryonal tumorpineoblastoma (PB)
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