Study of the effectiveness of drugs selected depending on the molecular profile of diffuse intrinsic pontine glioma (DIPG).
Key facts
- Where
- Katowice és Warsaw, LengyelországSee the 2 sites
- Phase
- 2. fázis
Where in Lengyelország
- Górnośląskie Centrum Zdrowia DzieckaKatowice, LengyelországTaking people
- Instytut Pomnik Centrum Zdrowia DzieckaWarsaw, LengyelországTaking people
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
- Instytut Pomnik Centrum Zdrowia Dziecka
- Trial code
- EU 2024-515952-19-00
- Record updated
- 2025. április 25.
- Original description
The aim of the study is to develop the optimal treatment for patients with DIPG by identifying molecular markers important for therapy, adjusting the type of medicinal product to the indicated markers and assessing the safety and efficacy of selected drugs (sirolimus, trametinib) in the treatment of DIPG in childrenRead full original descriptionShow less
Multicenter, open label study using molecularly determined targeted therapies in children 3-18 years of age with DIPG (diffuse intrinsic pontine glioma- DIPG)- DIPGen
The aim of the study is to develop the optimal treatment for patients with DIPG by identifying molecular markers important for therapy, adjusting the type of medicinal product to the indicated markers and assessing the safety and efficacy of selected drugs (sirolimus, trametinib) in the treatment of DIPG in children
Inclusion: Age 3 to 18 years, inclusive; Informed consent signed by parents or legal guardian of minor and by patient over 13 years of age) for the study diagnostic and therapeutic procedures, including molecular -based diagnostic and prognostic tests using NGS method; Diagnosis of diffuse intrinsic pontine glioma (DIPG) based on clinical and radiological criteria; Histological diagnosis of glioma WHO grade III and IV confirmed by reference pathologist.
Exclusion: Previous (< 5 yrs ) diagnosis of malignant neoplasm; Concomitant use of CYP3A or PgP inhibitors; Major surgery in the past 28 days; Any severe comorbid disease (eg kidney insufficiency, immunological deficiencies, HIV infection); Clinically significant cardiovascular condition ( eg arrythmia); Active infection requiring systemic treatment; Known allergy to the studied products; Radiological evidence of active intracranial hemorrhage (excluding receding post biopsy or focal bleeding).