Phase 2 open label randomized study of radiotherapy, concomitant nimotuzumab and vinorelbine and re-irradiation at relapse versus radiotherapy and multiple elective radiotherapy courses with concomitant vinorelbine and nimotuzumab for newly diagnosed childhood and adolescence diffuse intrinsic pontine glioma (DIPG).
Key facts
- Where
- Genoa, Milan, Naples, Rome és Turin, OlaszországSee the 5 sites
- Phase
- 2. fázis
Where in Olaszország
- IRCCS Istituto Giannina GasliniGenoa, OlaszországNo longer taking part
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, OlaszországNo longer taking part
- L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-PausiliponNaples, OlaszországNo longer taking part
- Bambino Gesu Childrens HospitalRome, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Trial code
- EU 2024-513654-30-00
- Record updated
- 2024. június 26.
- Original description
Primary aim of this study will be compare the best response up to 36 weeks (CR+PR) between conventional and experimental irradiation.Read full original descriptionShow less
Primary aim of this study will be compare the best response up to 36 weeks (CR+PR) between conventional and experimental irradiation.
Inclusion: Patients from 2 to 21 years old will be eligible; No previous treatment consented apart from steroids; Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons) [Hargrave]; Symptoms lasting less than 6 months, life expectancy ≥4 weeks; Karnowski/Lansky performance status ≥ 40 %; No organ dysfunction; no pregnancy or breast-feeding; Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory; Written and signed informed consent from parents or legal guardians will be obtained before starting the treatment; For diffuse midline glioma observational arm, central reviewed pathology of the disease according to standard Italian procedure, i.e. referral to the Neuropathology at Sapienza University in Rome.
Exclusion: Pre-treatment with radio or chemotherapy; Metastatic disease as shown by MRI; Patients below 2 years or over 21; Neurofibromatosis 1; Non-typical imaging; Symptoms duration over 6 months, Lansky/Karnowski scores below 40%; Organ dysfunction, pregnancy or breast-feeding; Absence of parents, patient or tutor consent; Not central review diagnosis of diffuse midline glioma histone H3, K27 mutated.