RecruitingEARLY_PHASE1INTERVENTIONAL

Pilot Trial for Treatment of Recurrent Glioblastoma

This is an early-stage study for people whose glioblastoma, a type of brain tumour, has returned. The trial will test personalised treatments based on the unique genetic make-up of each patient's tumour. Only 10 adults will take part. The main goals are to see if these new treatments are safe and well-tolerated, and to find out if it's practical to run a bigger study like this in the future. It's a 'pilot' trial, meaning it's a small-scale test to gather initial information, not a full trial designed to prove effectiveness yet. Participants will receive a specific drug from a pre-selected list, chosen to match their tumour's characteristics after surgery.

At a glance

Status

Recruiting

Phase

EARLY_PHASE1

Sponsor

AHS Cancer Control Alberta

Enrolment target

Start

27 Jun 2023

Estimated completion

01 Dec 2027

Glioblastoma Recurrent Disease Recurrent Glioblastoma

What is this study about?

This study is looking into a type of brain tumour called glioblastoma. When this type of tumour comes back after initial treatment, it's called 'recurrent glioblastoma'. This trial is an important early step to explore new ways to treat it. The idea is to offer a treatment that is tailored to each individual patient, based on the specific genetic information found in their tumour after it's been surgically removed.

Only a small number of people (10 adults) will take part in this initial pilot study. The main aims are to test if these personalised treatments are safe and if a larger study using this approach would be possible in the future. It's like a practice run, gathering important information before potentially moving on to a bigger, more comprehensive trial. The treatments being looked at here include several different medications: Afatinib, Dasatinib, Palbociclib, Everolimus, and Olaparib.

It's important to remember that this is a very early-stage trial. This means we don't yet know if these personalised treatments will be effective, but researchers hope to learn more as the study progresses. Taking part helps scientists understand more about glioblastoma and how best to treat it in the future, which could ultimately benefit many others.

Key takeaways

This is an early-stage study for recurrent glioblastoma.
Treatment will be personalised based on your tumour's genetics.
Only 10 adult patients will take part.
The main goal is to check safety and feasibility for future studies.
You must have surgery to remove the tumour before starting treatment.
Specific rules about contraception apply for both men and women.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. You will need to have a specific type of glioblastoma (called IDH-wild type) that has come back for the first or second time, even after you've had standard treatments like radiotherapy and chemotherapy (temozolomide).

Crucially, the doctors must be able to remove the tumour with surgery when it has returned. Your general health and ability to carry out daily activities should also be good to moderate (doctors use a score called ECOG, and you'd need to be 2 or less). All participants must agree to share their health information for the study by giving their informed consent.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting the study. Both men and women who could potentially have children must agree to use two reliable forms of contraception throughout the study and for six months after the last dose of treatment. This is to prevent pregnancy during the trial, as the effects of the study drugs on an unborn baby are unknown. Your doctor can explain which types of contraception are considered reliable for this study.

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 glioblastoma returned for the first or second time?
Can your recurrent tumour be surgically removed?
Are you able to manage your daily activities reasonably well (ECOG score of 2 or less)?
If you could get pregnant, are you willing to use two reliable forms of contraception?
If you are a man who could father a child, are you willing to use two reliable forms of contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have surgery to remove your recurrent glioblastoma. After surgery, your tumour's genetic makeup will be tested to help decide which specific study drug from the available options (Afatinib, Dasatinib, Palbociclib, Everolimus, or Olaparib) might be best for you. You will then receive this chosen personalised treatment.

Because this is a pilot study, the exact details of follow-up visits and tests will be explained to you by the study team. They will monitor your health closely to see how you are responding to the treatment and to check for any side effects. The total duration of your participation will depend on how you respond to the treatment and will be discussed with you before you join.

Potential risks and benefits

Participating in an early-stage clinical trial like this may offer potential benefits, such as access to new, personalised treatments not yet widely available. However, there are also potential risks, as these treatments are still being studied, and their full effects and side effects are not yet completely known. You might experience side effects from the medication. There is no guarantee that the treatment will be effective for your condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Arthur J.E. Child Comprehensive Cancer Centre
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is glioblastoma?

Glioblastoma is an aggressive type of brain tumour.

What does 'recurrent' mean?

Recurrent means the tumour has come back after previous treatment.

What is a 'pilot trial'?

A pilot trial is a small, early study to see if a bigger study is possible and to gather initial information.

Will I get to choose my treatment?

Your treatment will be chosen based on the genetic profile of your tumour after surgery, not by personal choice.

What are the drugs being tested?

The drugs are Afatinib, Dasatinib, Palbociclib, Everolimus, and Olaparib.

How to find out more

Paula de Robles, MD

paula.derobles@albertahealthservices.ca 587-231-6051 Official trial record

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