AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Phase I/IIa study of concomitant radiotherapy with olaparib and temozolomide in unresectable high grade gliomas patients

This research study is looking into a new treatment for a type of aggressive brain tumour known as glioblastoma. These are tumours that doctors can't remove with an operation. The study combines standard radiation therapy with two medicines, olaparib and temozolomide. Researchers want to find out if giving these treatments together is safe and if it can help shrink the tumour or slow its growth. This is an early-stage study, meaning it's one of the first times this specific combination is being tested in people. The aim is to understand how well people tolerate the treatment and if there are any promising signs it could be effective for future larger studies.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Centre Francois Baclesse

Enrolment target

Start

08 Nov 2024

Glioblastoma

What is this study about?

This study is about finding better ways to treat a serious type of brain tumour called glioblastoma. These tumours can be very difficult to treat, especially when they can't be fully removed with surgery. Doctors are always looking for new treatments to help people live longer and have a better quality of life.

In this study, researchers are combining a standard treatment, called radiotherapy (radiation therapy), with two new drugs: olaparib and temozolomide. Radiotherapy uses high-energy beams to kill cancer cells. Olaparib and temozolomide are drugs designed to target cancer cells in different ways. The idea is that using these treatments together might make them more effective than using them separately.

This is an early-stage study, called a Phase I/IIa study. This means the main goals are to check if the combination treatment is safe and what the right dose might be. It also aims to see if there are any early signs that the treatment is working. It's an important step in developing new treatments for glioblastoma.

Key takeaways

This study is for adults with an aggressive brain tumour called glioblastoma that cannot be removed by surgery.
It combines standard radiotherapy with two cancer drugs: olaparib and temozolomide.
The main aims are to check the new treatment's safety and look for early signs of effectiveness.
Participation involves regular hospital visits for treatment, tests, and monitoring.
You will be closely monitored for any side effects and can withdraw at any time.

Who may be eligible?

This study is for adults who have been diagnosed with an aggressive brain tumour called glioblastoma. Importantly, only people whose tumours cannot be completely removed by surgery are suitable for this study.

To join, participants must be at least 18 years old. Both men and women can take part. There will be other specific health requirements that your doctor will check to make sure the treatment is safe for you. These might include blood test results or how well other organs in your body are working.

It's important to remember that not everyone with glioblastoma will be able to join. The research team will carefully review your medical history to make sure this study is the right fit for you and that you meet all the criteria for safety.

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 18 years old or older?
Have you been diagnosed with glioblastoma?
Has your doctor told you that your glioblastoma cannot be fully removed by surgery?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive radiotherapy along with the two study drugs, olaparib and temozolomide. The treatment schedule, including how often you receive radiotherapy and the drugs, will be carefully explained to you by the study team. You will have regular appointments at the hospital to monitor your health, check for any side effects, and see how the treatment is affecting your tumour.

These appointments will involve physical examinations, blood tests, and imaging scans (like MRI scans) to track your progress. You will also be asked about how you are feeling and any symptoms you might have. Your total time in the study will depend on how you respond to the treatment and the study plan, but there will be a follow-up period after your main treatment has finished to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could potentially help you more than existing options, although there's no guarantee it will. The information learned from your participation will also help future patients. However, new treatments can have side effects, and some may be serious. The study team will monitor you closely for any unwanted effects and will explain all known risks before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is glioblastoma?

Glioblastoma is a very serious and fast-growing type of brain tumour that starts in the brain cells.

What does 'unresectable' mean?

It means the tumour is in a place in the brain where doctors can't safely remove all of it with surgery.

What are olaparib and temozolomide?

These are two different medicines that are used to treat cancer. In this study, they are being tested alongside radiation.

Is this a new treatment?

Yes, this study is testing a new combination of treatments to see if they work better together for glioblastoma.

Will I definitely get better if I join?

While doctors hope for positive results, there's no guarantee this treatment will cure your cancer or make you feel better. The main goal is to learn if it's safe and shows promise.