BridgeMD
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
EU CTIS ID: 2024-518964-11-01
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- Administration of a first-line chemotherapy cycle at the same time as the start of the study
- Concomitant partecipation to other clinical trial
- Pregnancy or breastfeeding
- Inadequate contraception by patients of both sexes
See the full eligibility criteria
- 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)
- 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
- Administration of a first-line chemotherapy cycle at the same time as the start of the study
- Concomitant partecipation to other clinical trial
- Pregnancy or breastfeeding
- Inadequate contraception by patients of both sexes
- Hypersensibility to active principles or excipients
- Severe bone-marrow depression
- Concomitant administration of live attenuated vaccines
- Inability to comply for study follow-up
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.