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RecruitingPHASE2INTERVENTIONAL

Pediatric Low Grade Glioma - MEKinhibitor TRIal vs Chemotherapy

This study is for children and young people aged 1 month to 25 years who have a slow-growing brain tumour called pediatric low-grade glioma (PLGG). While many patients do well, some tumours need treatment to prevent long-term problems. Current treatments sometimes don't stop the tumour from growing for long enough or can have side effects. This trial compares a new medicine, Trametinib, with a standard treatment, Vinblastine, to see if Trametinib is more effective at preventing the tumour from growing back. It's hoped that this new targeted treatment could improve outcomes, reduce side effects, and offer a better quality of life for young patients with specific types of PLGG.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
University Hospital, Strasbourg, France
Enrolment target
134
Start
05 May 2022
Estimated completion
01 Dec 2031

What is this study about?

This study focuses on a type of brain tumour in children and young adults called paediatric low-grade glioma (PLGG). These tumours are the most common brain tumours in this age group. While many children do very well, some tumours are in difficult locations or grow over time, meaning they need treatment to stop them causing problems.

Currently, there are standard treatments like chemotherapy, but doctors are always looking for ways to make treatments more effective, with fewer side effects. Recent discoveries have shown that some of these tumours have specific genetic changes. This has led to the development of new "targeted" medicines that specifically aim at these changes, potentially offering a more precise way to treat the tumour.

This trial, called PLGG-MEKTRIC, is looking at a new targeted medicine called Trametinib. It's being compared to a standard chemotherapy medicine called Vinblastine. The main goal is to see if Trametinib can prevent the tumour from growing or coming back for a longer period of time. This could mean better results and potentially a better quality of life for children and young adults with specific types of low-grade gliomas that are part of this study.

Key takeaways

  • Study for children/young adults (1 month - 25 years) with specific slow-growing brain tumours.
  • Compares a new targeted medicine (Trametinib) with a standard chemotherapy (Vinblastine).
  • Aims to see if Trametinib is better at preventing tumour growth.
  • Requires specific genetic test results for the tumour.
  • Involves regular hospital visits, scans, blood tests, and quality of life questionnaires.
  • Participation lasts up to 3 years.

Who may be eligible?

This study is suitable for children and young adults aged from 1 month up to 25 years. Participants must have a specific type of slow-growing brain tumour called grade 1 glioma, mixed glio-neuronal tumour, or pleomorphic xanthoastrocytoma.

Critically, your tumour must have specific genetic test results – it cannot have a mutation called BRAFv600, and it shouldn't be associated with a condition called NF1. If your child is under one year old and has a tumour in certain areas (chiasmatic and/or hypothalamic), they might also be considered.

Patients taking part need to be generally well enough, with a good level of physical activity, as assessed by doctors. There are also specific rules about how the tumour has changed over time or if it's causing new or worsening symptoms that mean treatment is needed, for example, if vision or nerve function is affected.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you/your child aged between 1 month and 25 years?
  2. Do you/your child have a Grade 1 glioma, mixed glio-neuronal tumour, or pleomorphic xanthoastrocytoma?
  3. Has the tumour been tested and confirmed to NOT have the BRAFv600 mutation and NOT be linked to NF1?
  4. Is the tumour causing symptoms or growing, requiring treatment?
  5. Are you/your child generally well enough to take part?
  6. Is a fresh or frozen tumour sample available for further testing?
Answer every question to see your result.

What does participation involve?

If you or your child join this study, you will be randomly assigned to receive either the new medicine, Trametinib, or a standard treatment, Vinblastine. This means it's like flipping a coin – you won't get to choose which one. Both treatments will be given over a period of time, with Vinblastine typically given weekly for about 18 cycles (lasting about 72 weeks). Trametinib is taken daily.

During the treatment period and for three years after the first dose, you will have regular hospital visits. These visits will involve scans (like MRI) to check the tumour, blood tests, and health assessments to see how you are responding to the treatment and to monitor for any side effects. You'll also complete questionnaires about your quality of life at various points. The total time you'll be involved with the study for follow-up could be up to three years.

Potential risks and benefits

Potential benefits of taking part could include receiving a new treatment that might be more effective at stopping the tumour from growing, or having closer monitoring of your condition. However, there are potential risks, as all medicines can have side effects. Doctors will carefully monitor for any side effects (adverse events) throughout the study. You will be told about all known risks before you decide to take part. It's important to remember that you are free to withdraw from the study at any time, for any reason, without affecting your or your child's future medical care.

Locations (25)

  • Chu Amiens Picardie
    Verified postcode
    Amiens, France· Not yet recruiting
  • Chu D'Angers
    Verified postcode
    Angers, France· Recruiting
  • Chu de Besancon
    Verified postcode
    Besançon, France· Recruiting
  • Groupe Hospitalier Pellegrin
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • Chu de Brest Morvan
    Verified postcode
    Brest, France· Recruiting
  • CHU CAEN
    Verified postcode
    Caen, France· Not yet recruiting
  • Chu Dijon Bourgogne
    Verified postcode
    Dijon, France· Not yet recruiting
  • Chu Grenoble Alpes
    Verified postcode
    Grenoble, France· Recruiting
  • Clcc Oscar Lambret Lille
    Verified postcode
    Lille, France· Recruiting
  • Chu Limoges
    Verified postcode
    Limoges, France· Not yet recruiting
  • Centre Leon Berard
    Verified postcode
    Lyon, France· Recruiting
  • APHM
    Verified postcode
    Marseille, France· Recruiting

Common questions

What is a 'low-grade glioma'?

It's a type of slow-growing brain tumour found in children and young adults. 'Low-grade' means it's less aggressive than other types.

What are 'targeted therapies'?

These are medicines that aim at specific features or changes in cancer cells, rather than affecting all cells like traditional chemotherapy. This can sometimes lead to fewer side effects.

Will I know which treatment I'm getting?

Yes, this is an 'open' study, meaning you will know if you are receiving Trametinib or Vinblastine.

How long will the treatment last?

The Vinblastine treatment is planned for about 72 weeks. The duration of Trametinib will be determined by how well the patient is tolerating it and how the tumour is responding.

What if my child's tumour grows worse on the standard treatment?

If patients on the standard Vinblastine treatment see their tumour grow, they may be offered the experimental Trametinib treatment instead.

How to find out more

Natacha ENTZ-WERLE

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Pediatric Low Grade Glioma - MEKinhibitor TRIal vs Chemother…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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