Clinical study to assess safety and efficacy of rapamycin in paediatric high grade glioma
Key facts
- Where
- Katowice, Lodz és Warsaw, LengyelországSee the 3 sites
- Phase
- 2. fázis
Where in Lengyelország
- Górnośląskie Centrum Zdrowia DzieckaKatowice, LengyelországNo longer taking part
- Uniwersytet Medyczny w LodziLodz, LengyelországNo longer taking part
- Instytut Pomnik Centrum Zdrowia DzieckaWarsaw, LengyelországNo 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
- Instytut Pomnik Centrum Zdrowia Dziecka
- Trial code
- EU 2024-515951-39-00
- Record updated
- 2025. január 11.
- Original description
The primary objective of the study is to determine safety and tolerability of rapamycin in the treatment of high grade glioma in childrenRead full original descriptionShow less
An open randomized phase II clinical trial evaluating the safety and efficacy of rapamycin in the treatment of gliomas high-grade malignant gliomas in children as part of the establishment management of rare and ultra rare diseases of the central nervous system associated with mTOR pathway activation: BraimTOR- ONKO
The primary objective of the study is to determine safety and tolerability of rapamycin in the treatment of high grade glioma 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; Histological diagnosis of glioma WHO grade III and IV confirmed by reference pathologist; Negative result of the pregnancy test performed within 2 weeks prior to the start of the study in patients of reproductive age; Written consent to the use of effective contraception in sexually active patients.
Exclusion: Live vaccine intake <6 weeks prior to study inclusion; Receipt of inactivated vaccine or mRNA vaccine <4 weeks prior to study inclusion; 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); Diagnosis of DIPG.