Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Adjuvant dendritic cell immunotherapy complementing conventional therapy for pediatric patients with high-grade glioma and diffuse intrinsic pontine glioma

This study is exploring a new treatment for children with serious brain tumours called high-grade glioma (HGG) and diffuse intrinsic pontine glioma (DIPG). The treatment uses a special vaccine called a 'dendritic cell vaccine,' which helps teach the body's immune system to fight cancer cells. Researchers want to find out if this vaccine is safe, how well it can be made, and if children can complete the treatment alongside their standard care. They are closely monitoring for any side effects and also looking at whether the vaccine helps slow down the disease or improve a child's quality of life. This is an early-stage study to understand more about this new approach.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Antwerp University Hospital

Enrolment target

Start

04 Nov 2024

High-grade glioma (HGG)Diffuse intrinsic pontine glioma (DIPG)

What is this study about?

This study is for children who have been diagnosed with two specific types of brain tumours: high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). These are serious conditions, and researchers are always looking for better ways to help children facing them.

The main idea behind this study is to see if a special type of 'vaccine' can be used safely and effectively alongside the usual treatments. This isn't a vaccine like the flu jab; instead, it's designed to help the body's own defence system, called the immune system, learn to recognise and fight the cancer cells. It's made by taking some special cells (called dendritic cells) from the child's blood and 'teaching' them in a lab to target specific parts of the cancer.

Because this is a new approach, the study has several important goals. First, it wants to make sure the vaccine is safe and doesn't cause too many serious side effects. Second, it's checking how practical it is to make this vaccine for each child and whether children can actually complete all parts of the treatment plan. They will also be looking closely at information such as how well patients respond to treatment, how long they stay well, their overall survival, and how their quality of life changes throughout the study. This information will help doctors understand if this new vaccine could be a helpful additional treatment in the future.

Key takeaways

This study is testing a new 'vaccine' treatment for children with certain serious brain tumours.
The vaccine aims to train the child's immune system to fight cancer cells.
It will be used in addition to a child's standard cancer treatments.
The study mainly wants to check if the vaccine is safe and practical to use.
Doctors will also look for signs that the treatment is helping children.
Participation involves blood collection, vaccine injections, and regular check-ups.

Who may be eligible?

This study is open to both boys and girls of any age who have high-grade glioma or diffuse intrinsic pontine glioma.

Before you or your child can join, the doctors will need to carefully check a few things to make sure the study is a good fit. This helps ensure that the treatment is as safe as possible and that the results of the study are clear and reliable.

They'll look at your child's overall health, their specific type of tumour, and any other treatments they might be having. It's really important to discuss all of this with the study doctors to understand if your child can take part.

Quick self-check

Does my child have high-grade glioma (HGG)?
Does my child have diffuse intrinsic pontine glioma (DIPG)?
Is my child currently receiving standard treatment for their brain tumour?
Can my child attend regular hospital visits for monitoring and vaccine administration?
Am I, or am I able to be, the legal guardian of the child?

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

What does participation involve?

If your child takes part in this study, it involves several steps over a period of time. First, some of your child's blood will be collected in a process called leukapheresis – this is similar to donating blood, but takes out specific cells. These cells are then used to make the special vaccine in a lab. Your child would then receive up to nine doses of this vaccine over several visits, usually given as injections. Throughout this time, and for a period afterwards, there will be regular hospital visits. During these visits, doctors will monitor your child closely, check for any side effects, and perform tests to see how the immune system is responding and how the tumour is behaving. They'll also ask about your child's wellbeing and quality of life. The exact duration of participation will depend on the child's response and the study schedule, but it involves monitoring for a significant period after vaccine administration.

Potential risks and benefits

Participating in a study like this offers the potential benefit of accessing an investigational treatment that might help the immune system fight the child's cancer, potentially improving their condition or quality of life. However, as it's a new treatment, there are also potential risks of side effects, which could range from mild discomfort at the injection site to more serious reactions. The research team will carefully monitor your child for any adverse effects. You and your child have the absolute right to withdraw from the study at any time, for any reason, without it affecting their future medical care.

Locations (1)

—
Belgium

Common questions

What is a 'dendritic cell vaccine'?

It's a treatment made from your child's own blood cells that helps teach their immune system to recognise and attack cancer cells.

What are high-grade glioma (HGG) and DIPG?

These are types of serious brain tumours that affect children. This study is specifically looking at new treatments for them.

Will this vaccine replace my child's current treatment?

No, this study is looking at using the vaccine "complementing conventional therapy," meaning it would be given alongside your child's usual treatments.

What does a 'Phase II' study mean?

This means it's an earlier stage study focused on finding out if the treatment is safe and practical to use, and if it shows any signs of working, rather than a large comparison study.

What kind of side effects might my child experience?

Side effects are being closely monitored. They could be mild, like soreness where the vaccine is given, or potentially more serious. The doctors will explain all known possibilities.