RecruitingPHASE2INTERVENTIONAL

Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma

This study is for adult patients whose glioblastoma, a common and aggressive type of brain tumour, has started to grow again after their first course of treatment. Current standard treatments don't always stop the cancer from coming back, and there's no clear best approach when it does. This study will test two different drug combinations, given directly into the blood vessels supplying the brain. This method aims to get more medicine to the tumour by bypassing the natural protective barrier around the brain. Researchers want to find out which combination is better at slowing down the cancer's growth and improving patients' overall health and quality of life.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Université de Sherbrooke

Enrolment target

120

Start

01 Aug 2025

Estimated completion

01 Apr 2028

Glioblastoma Multiforme Relapse

What is this study about?

Glioblastoma is the most common and aggressive type of brain tumour in adults. After surgery, patients usually have radiotherapy and chemotherapy with a drug called temozolomide. While this treatment helps, the tumour often starts to grow again. When this happens, doctors don't have a standard 'next step' treatment, and it can be challenging to get medicines directly to the brain because of a natural protective barrier called the blood-brain barrier.

This study is looking at a new way to deliver chemotherapy drugs directly into the blood vessels that supply the brain. This 'intra-arterial' (IA) method aims to get more of the medicine right to where the tumour is, hoping to make it more effective. The researchers want to see if this approach, using combinations of older, known chemotherapy drugs, can help slow the cancer's growth and improve how long patients live without the cancer getting worse.

Specifically, the study will compare two different drug combinations: carboplatin plus Caelyx (a form of doxorubicin) versus carboplatin plus etoposide phosphate. Both combinations will be given using the intra-arterial method. The main goal is to find out which combination works better at shrinking the tumour and stopping its growth, and how these treatments affect a patient's quality of life and brain function.

Key takeaways

This study evaluates new ways to treat recurrent glioblastoma.
It tests two drug combinations delivered directly to the brain via blood vessels.
The aim is to find better options when initial treatments stop working.
Participation involves regular treatments, MRI scans, and quality of life assessments.
It's for adults whose glioblastoma has come back after standard first-line therapy.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with glioblastoma. Your cancer must have started to grow again after you've already had the standard initial treatment, which includes radiotherapy and temozolomide. Doctors will need to see this growth on a scan, and you should be generally well enough to take part.

There are also some important blood test results needed to make sure your body can handle the treatment, particularly that your blood counts, liver, and kidney functions are within safe limits. Your heart health will also be checked. Women who are pregnant or breastfeeding, or who could become pregnant, will not be able to join. Also, if you have other serious health conditions like active autoimmune disease, a recent history of certain heart problems, or another cancer treated recently, you might not be eligible.

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?
Has your brain tumour (glioblastoma) grown back after your first treatment?
Are your blood counts, liver, and kidney functions generally healthy?
Do you have a KPS score of 60% or higher, indicating good general health and function?
Are you able to use contraception if necessary, or are you sterile?
Do you *not* have other serious medical conditions like active autoimmune disease or recent heart problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive treatment after your glioblastoma has relapsed. If your doctor thinks it's helpful, you might have surgery to remove some of the tumour first. Then, you would receive one of two drug combinations directly into the blood vessels of your brain (this is done through a small tube inserted into an artery, usually in your leg). These treatments are given every 4 to 6 weeks, and you could have up to 12 cycles, which means nearly a year of treatment.

Throughout the study, you'll have regular MRI scans every month to check how the tumour is responding. Doctors will also closely monitor you for any side effects from the treatment. You'll also be asked to complete questionnaires to assess your quality of life and some tests to check your brain function and memory.

Potential risks and benefits

Taking part in this study may offer some potential benefits by providing access to new treatment approaches that might help control your glioblastoma when standard options are limited. However, like all medical treatments, there are potential risks, including side effects from the chemotherapy drugs or the procedure to deliver them. The study team will carefully monitor you for these and explain them fully. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

CHUS
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is 'intra-arterial' drug delivery?

It means the medicines are given directly into the blood vessels that feed the brain, aiming to get more drug to the tumour and avoid the body's natural brain barrier.

What is the 'blood-brain barrier'?

It's a natural protective shield around your brain that stops many substances, including some medicines, from getting in.

What does 'relapse' mean in this study?

It means your glioblastoma cancer has started to grow again after you've already had your first course of treatment.

Will I know which drug combination I'm getting?

The study design will determine this, but typically in these types of studies, you would know which treatment group you are assigned to.

How long will I be in the study if I participate?

You could receive up to 12 cycles of treatment, with each cycle lasting 4-6 weeks, potentially meaning nearly a year of active treatment, plus follow-up assessments.

How to find out more

David Fortin, MD

david.fortin@usherbrooke.ca 819-346-1110 Official trial record

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