Active not recruitingPHASE2INTERVENTIONAL

Efficiency of Vaccination with Lysate-loaded Dendritic Cells in Patients with Newly Diagnosed Glioblastoma

This study is investigating a new approach for people recently diagnosed with glioblastoma, a serious type of brain tumour. Researchers are testing a special vaccine made from a patient's own tumour cells, given alongside their usual treatment. The goal is to see if adding this vaccine helps patients live longer compared to standard care alone, which includes surgery, radiation, and chemotherapy. This is a Phase 2 study, meaning it's still in earlier stages of testing, looking at how well the vaccine works and its safety.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

136

Start

06 Mar 2018

Estimated completion

01 May 2027

Glioblastoma

What is this study about?

This research study is focused on a type of brain tumour called glioblastoma. When someone is diagnosed with glioblastoma, they usually have surgery to remove as much of the tumour as possible, followed by a combination of radiotherapy and chemotherapy (a drug called temozolomide). This is known as standard care.

This study is trying a new approach by adding a special vaccine to this standard treatment. This isn't like a flu vaccine; it's a personalised vaccine made from your own tumour cells. The idea is to teach your body's immune system to recognise and fight any remaining cancer cells. Researchers want to find out if this vaccine helps people with glioblastoma live longer than they would with standard treatment alone.

The study involves patients who have recently been diagnosed with glioblastoma and have had most of their tumour removed during surgery. The vaccine would be given after your radiation and initial chemotherapy, and then alongside some of your later chemotherapy cycles. It's a 'randomised' study, meaning some participants will receive the vaccine plus standard care, while others will just receive standard care. This helps researchers fairly compare how effective the new treatment is.

Key takeaways

This study evaluates a personalised vaccine for newly diagnosed glioblastoma.
The vaccine is given in addition to standard treatments (surgery, radiation, chemotherapy).
It aims to train your immune system to fight cancer cells.
The main goal is to see if adding the vaccine helps patients live longer.
It's for people who have had most of their tumour removed by surgery.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have recently been diagnosed with a specific type of glioblastoma. It's important that you understand the study and agree to take part by signing a consent form.

A key requirement is that your surgeon must have removed almost all of the tumour, leaving very little behind (less than a small blueberry-sized piece). We'll also need a sample of your tumour tissue to create the special vaccine.

Your general health needs to be good enough to participate, meaning your liver, kidneys, and blood cell counts should be within a normal range. You'll also need to be able to move around fairly well.

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.

Are you at least 18 years old?
Have you recently been diagnosed with a specific type of glioblastoma?
Has most of your tumour been successfully removed during surgery (checked by scans)?
Is your overall health, including liver, kidney, and blood tests, considered good?
Are you able to understand and sign the consent form for the study?

Answer every question to see your result.

What does participation involve?

If you join this study, your regular treatment for glioblastoma (surgery, radiation, and temozolomide chemotherapy) would remain the same. The main difference is the addition of the new vaccine. This vaccine is made from your own tumour cells, which means a small piece of your tumour from surgery will be used to create your personalised vaccine.

Vaccinations would begin after you've completed your radiation and initial chemotherapy treatments. They will continue alongside the first few cycles of your ongoing temozolomide chemotherapy. The study team will monitor you closely throughout this period, requiring regular visits and tests to check your health and how you're responding to treatment.

Potential risks and benefits

Participating in a study like this isn't a guarantee of benefit, but there's a chance the vaccine could help improve your outcome or extend your life compared to standard treatment. However, as with any medical treatment, there are potential risks and side effects from the vaccine itself, which will be fully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Klinik für Neurologie, Knappschaftskrankenhaus Bochum
Verified postcode
Bochum, Germany
Klinik für Neurochirurgie, Sana Kliniken Duisburg
Verified postcode
Duisburg, Germany
Neurochirurgische Klinik, Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany
St. Marien Hospital Lünen, Klinik für Neurochirurgie
Verified postcode
Lünen, Germany
Klinik für Allgemeine Neurologie, Universitätsklinikum Münster
Verified postcode
Münster, Germany
Helios Klinikum Krefeld, Klinik für Neurochirurgie
Verified postcode
Krefeld, Germany

Common questions

What is glioblastoma?

Glioblastoma is an aggressive type of cancer that starts in the brain. It grows quickly and requires intensive treatment.

What is a 'vaccine' in this study?

It's not a vaccine like for the flu. This special vaccine is made using cells from your own tumour and is designed to teach your immune system to fight your cancer.

What does 'standard care' mean?

Standard care refers to the usual treatments for glioblastoma that are already scientifically proven to be effective. This typically includes surgery, radiation, and chemotherapy.

Why is my tumour removed first?

Surgery is the first step to remove as much of the glioblastoma as possible. A sample from this surgery is also crucial to make the personalised vaccine for the study.

Will I know if I'm getting the vaccine?

Because this is a 'randomised' study, some participants will receive the vaccine plus standard care, and others will receive standard care alone. The study team can explain if you will know which group you are in.