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Taking people in PolandPhase 2

Tests drugs chosen by tumor molecular profile in children with DIPG brain tumor

Tests sirolimus or trametinib, chosen by tumor markers, in children with DIPG.

Key facts

Who runs it
Instytut Pomnik Centrum Zdrowia Dziecka
Where
Katowice and Warsaw, PolandSee the 2 sites
Registry title
Study of the effectiveness of drugs selected depending on the molecular profile of diffuse intrinsic pontine glioma (DIPG).
Status
Recruiting
Phase
Phase 2
People taking part
100 people, planned
Started
18 Dec 2024
Planned end
30 Jun 2026
Type of study
Interventional
Record updated
25 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 3 to 18 with diffuse intrinsic pontine glioma (DIPG), a brain stem tumour. They get drugs chosen by the molecular profile of the tumour.

Age
3 to 18 years, inclusive
Sex
All sexes
Disease stage
Diffuse intrinsic pontine glioma (DIPG) diagnosed by clinical and radiological criteria, with glioma WHO grade III or IV confirmed by a reference pathologist
Biomarker or test result
The tumour is tested for molecular markers with the NGS method; the drug (sirolimus or trametinib) is chosen to fit the markers found

Main reasons for not taking part

  • Any severe other disease, for example kidney insufficiency, immune deficiency or HIV infection
  • Clinically significant heart or blood vessel problem, for example arrhythmia
  • Another malignant tumour diagnosed in the past 5 years
  • Active infection that needs treatment with medicine given into the body (systemic treatment)
  • Major surgery in the past 28 days

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Poland

  • Górnośląskie Centrum Zdrowia DzieckaKatowice, PolandTaking people
  • Instytut Pomnik Centrum Zdrowia DzieckaWarsaw, PolandTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Multicenter, open label study using molecularly determined targeted therapies in children 3-18 years of age with DIPG (diffuse intrinsic pontine glioma- DIPG)- DIPGen
Plain-language title
Tests drugs chosen by tumor molecular profile in children with DIPG brain tumorGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
25 April 2025