RecruitingOBSERVATIONAL

Targeted Pediatric High-Grade Glioma Therapy

This research is focused on understanding and potentially improving treatments for aggressive brain tumours in children, teenagers, and young adults. If you or someone you know has recently been diagnosed with a brain tumour like a high-grade glioma or DIPG, this study might be relevant. The main goal is to carefully examine the genetic information within these tumours. By looking closely at the genes, doctors hope to identify specific changes that could help guide future treatment options. Patients participating in this initial stage will have their tumour's genetic code mapped out. This information will then be used to determine if they might be eligible to join a separate, future treatment study that uses medicines tailored to these specific genetic changes. It's about finding the best way forward by understanding the unique biology of each tumour.

At a glance

Status

Recruiting

Sponsor

Nationwide Children's Hospital

Enrolment target

350

Start

02 Aug 2024

Estimated completion

28 Aug 2034

High Grade Glioma Diffuse Intrinsic Pontine Glioma Anaplastic Astrocytoma Glioblastoma Glioblastoma Multiforme Diffuse Midline Glioma, H3 K27M-Mutant Metastatic Brain Tumor WHO Grade III Glioma WHO Grade IV Glioma

What is this study about?

This study is designed to help children, teenagers, and young adults who have been newly diagnosed with a type of aggressive brain tumour called high-grade glioma, which includes conditions like Diffuse Intrinsic Pontine Glioma (DIPG).

The main idea behind this research is to get a much clearer picture of these tumours at their most basic level – their genes. Think of it like getting a very detailed blueprint of the tumour. By carefully studying this genetic blueprint, doctors hope to find specific features or changes that could make the tumour respond better to certain treatments. This detailed genetic information will be used to see if a patient might be suitable for specific new treatment programmes in the future.

Ultimately, this study aims to move towards more personalised treatment. Instead of a one-size-fits-all approach, the goal is to understand what drives each individual tumour and then match patients to treatments that are most likely to be effective for their unique condition. This detailed understanding can also help researchers discover new ways to track how a tumour is responding to treatment or why it might become resistant.

Key takeaways

This study aims to deeply understand childhood brain tumours through genetic testing.
It's for children, teenagers, and young adults (1-39 years old) with high-grade gliomas or DIPG.
The goal is to find personalised treatment approaches for the future.
Participation involves genetic analysis of your tumour sample and ongoing monitoring.
You can have had some initial treatments like surgery or radiotherapy.
This study helps shape future targeted treatment options.

Who may be eligible?

This study is for children, teenagers, and young adults between 12 months (1 year old) and 39 years old who have recently been diagnosed with a high-grade brain tumour, such as high-grade glioma or DIPG. The diagnosis of the tumour must have been confirmed by samples taken from a biopsy or surgery.

For most tumours, the grade needs to be WHO grade 3 or 4. If it's a DIPG, it must be located in a specific area of the brainstem and have features consistent with a diffuse glioma. The study is open to patients regardless of whether their tumour has spread or if it's in the spine.

Patients can have had some initial treatments like surgery, radiotherapy, or certain medications (like dexamethasone). However, generally, they should not have received other types of anti-cancer treatments for their high-grade glioma before joining this study.

Quick self-check

Are you between 1 and 39 years old?
Have you been newly diagnosed with a high-grade brain tumour (like glioma or DIPG)?
Has your tumour diagnosis been confirmed by a doctor?
Have you only had surgery, radiotherapy, or certain steroid medications (like dexamethasone) for your tumour so far?
Is a sample of your tumour available for genetic testing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, the main step involves doctors getting a sample of your tumour tissue. This sample will then undergo very detailed genetic testing to understand its unique characteristics. This will help determine if you could be eligible for a future treatment study tailored to the specific genetic changes found in your tumour.

Your journey will start with this 'screening' phase, where the genetic details of your tumour are mapped out. You'll also have regular check-ups, which may include blood tests, samples of the fluid around your brain and spinal cord (if appropriate), and advanced brain scans. These checks help doctors understand how your body is doing and how the tumour might be changing. The total duration of participation in this initial screening phase itself isn't specified, but it's focused on gathering information before potential enrollment in a treatment arm.

Potential risks and benefits

Taking part in research always has potential benefits and risks. A potential benefit of this study is gaining a very detailed understanding of your tumour's genetic makeup, which could help identify new insights for your care or future treatment options. It also contributes to a broader understanding of these brain tumours, which could help future patients. Risks are generally associated with the procedures to collect samples, such as biopsies or blood tests, which carry small risks like infection or bruising. You can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (21)

Children's Hospital Colorado
Aurora, United States· Not yet recruiting
Children's National Medical Center
Washington D.C., United States· Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, United States· Recruiting
Dana-Farber Cancer Institute
Boston, United States· Not yet recruiting
C.S. Mott Children's Hospital
Ann Arbor, United States· Recruiting
Duke University Health System
Durham, United States· Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, United States· Recruiting
Nationwide Children's Hospital
Columbus, United States· Recruiting
Children's Hospital of Philadelphia
Philadelphia, United States· Not yet recruiting
Texas Children's Hospital
Houston, United States· Recruiting
Seattle Children's Hospital
Seattle, United States· Recruiting
Sydney Children's Hospital
Randwick, Australia· Recruiting

+9 more sites — see the official record for the full list.

Common questions

What kind of brain tumours is this study looking at?

This study is focused on aggressive brain tumours in children, teenagers, and young adults, specifically high-grade gliomas, including a type called DIPG.

What will happen if I take part?

Doctors will analyse a sample of your tumour to understand its genetic information. This will help guide whether you might be suitable for specific treatment studies in the future.

Will I receive new treatment in this study?

This particular study focuses on understanding your tumour's genetics. Based on these findings, you might become eligible for a separate, future study that involves new treatments 'tailored' to your tumour.

How old do I need to be to join?

You need to be between 12 months (1 year) and 39 years old at the time of joining this study.

Have I had too much treatment already?

You can usually still join if you've had surgery, radiotherapy, or certain steroid medications. However, generally, you shouldn't have had other anti-cancer treatments for your brain tumour.

How to find out more

Kelsey H Troyer, PhD

kelsey.troyer@nationwidechildrens.org 16147223284 Official trial record

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