2024-515951-39-00CompletedPhase 2
Clinical study to assess safety and efficacy of rapamycin in paediatric high grade glioma
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Jan 2025
Brief summary (registry, in English)
The primary objective of the study is to determine safety and tolerability of rapamycin in the treatment of high grade glioma in children
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 16 Oct 2024
- Start date
- 16 May 2023
- Lead sponsor
- Instytut Pomnik Centrum Zdrowia Dziecka
- Diseases
- Childhood cancers
- EU CT number
- 2024-515951-39-00
- EudraCT number
- 2021-006689-18
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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).
Other
- Diagnosis of DIPG
Who the study is looking for
- 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.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Górnośląskie Centrum Zdrowia Dziecka | Katowice | Poland | Completed |
| Uniwersytet Medyczny w Lodzi | Lodz | Poland | Completed |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.