An interventional, open-label, Phase II study, to evaluate safety and efficacy of standard and high-dose chemotherapy associated with craniospinal irradiation in patients with metastatic medulloblastoma and other embryonal tumours
Key facts
- Where
- Florence, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, 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
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Trial code
- EU 2024-518964-11-01
- Record updated
- 2025. január 27.
- Original description
To evaluate safety of first line standard and high-dose chemotherapy associated with craniospinal irradiation in pediatric and young adult patients with high risk medulloblastoma and other embryonal tumoursRead full original descriptionShow less
To evaluate safety of first line standard and high-dose chemotherapy associated with craniospinal irradiation in pediatric and young adult patients with high risk medulloblastoma and other embryonal tumours
Inclusion: First diagnosed, previously untreated, patients with high-risk medulloblastoma (according to WHO 2016 classification): metastatic; anaplastic or large cell; partially resected (residual volume on two floors> 1.5cm2) according to WHO classification (2016); N-MYC C-MYC amplified; Written informed consent obtained from the patient/parents or legal representative; Availability for treatment and ability to be compliant with the protocol; Patients with other embryonic tumors (WHO classification 2016) - embryonic tumor with C19MC-altered multilayer rosettes; embryonic tumor with multilayer rosettes not otherwise specified, medulloepithelioma, CNS neuroblastoma, CNS ganglioneuroblastoma, CNS embryonic tumor not otherwise specified, CNS embryonic tumor with rhabdoid features - of first diagnosis, previously untreated (with chemo and radiotherapy) and treated only surgically; First diagnosed Pinealoblastomas (WHO 2016), previously untreated (with chemo and radiotherapy) and treated only surgically; Males and females aged >3 years and <21 years at time of the diagnosis; Life expectancy > or = 12 months; Karnofsky/Lansky > or = 40 %; Adequate hematological function (leucocyte > or = 2.0 x 10^9/l - Hemoglobin > or = 10 g/dl - platelet > or = 50 x 10^9/l); Adequate liver function (total bilirubin < or = 2.5 x ULN - ALT/AST < or = 5.0 x ULN); Adequate renal function (serum creatinine < or = 1.5 x ULN).
Exclusion: Administration of a first-line chemotherapy cycle at the same time as the start of the study; Concomitant partecipation to other clinical trial; Concomitant administration of live attenuated vaccines; Any disease or condition that contraindicates the use of the study treatment (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy, psychosocial problems); Other contraindications reported in the SmPC; Pregnancy or breastfeeding; Inadequate contraception by patients of both sexes; Hypersensibility to active principles or excipients; Severe bone-marrow depression; Inability to comply for study follow-up.