Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
This research is for older patients (aged 65 and over) newly diagnosed with an aggressive brain cancer called glioblastoma. Standard treatment often involves radiation and a chemotherapy drug called Temozolomide. However, some tumours have a specific marker (called "unmethylated MGMT") that means the usual Temozolomide might not be as effective. This study is exploring a different way to give Temozolomide chemotherapy. Instead of the usual schedule, it will be given daily over a period. The hope is that this new approach can help slow down the disease and improve how long patients live, especially for those whose tumours have this specific marker. It's a Phase 2 study, meaning it's still in the early stages of testing this specific treatment approach.
At a glance
What is this study about?
Glioblastoma is a serious and fast-growing type of brain cancer. When someone is diagnosed, the usual treatment involves a combination of radiation therapy (which uses high-energy rays to kill cancer cells) and a chemotherapy drug called Temozolomide. This standard approach usually starts with a three-week course of radiation given with some Temozolomide, followed by a break, and then more Temozolomide chemotherapy.
However, we know that glioblastoma tumours are not all the same. Some of them have a particular feature, a marker called "unmethylated MGMT." For patients whose tumours have this marker, the standard way of giving Temozolomide might not work as well as it does for others. This means we need to explore different ways to help these patients.
This study aims to find a better treatment option for older patients whose glioblastoma has this "unmethylated MGMT" marker. Instead of the usual chemotherapy schedule, this research is testing giving Temozolomide chemotherapy daily. The goal is to see if this different schedule can help control the cancer more effectively, slow its growth, and ultimately help people live longer and have a better quality of life.
Key takeaways
- Targets older patients (65+) with newly diagnosed glioblastoma.
- Focuses on tumours with a specific marker: 'unmethylated MGMT'.
- Tests a modified, daily schedule of existing Temozolomide chemotherapy.
- Aims to improve disease control and survival where standard treatment may be less effective.
- Participation involves regular hospital visits, blood tests, and MRI scans.
- You can withdraw from the study at any time.
Who may be eligible?
This study is for people aged 65 or older who have been recently diagnosed with a specific type of aggressive brain cancer called glioblastoma. Crucially, your tumour must have a particular marker called "unmethylated MGMT." You will also need to have already completed a three-week course of radiation therapy along with Temozolomide chemotherapy.
To be considered, you'll need to be generally well enough to take part in the study, which doctors will check using special scores (like ECOG and KPS). You'll also need to have healthy organ function, which will be checked with blood tests. Lastly, you must be able to have an MRI scan.
You cannot join if your cancer has spread to the lining of the brain, if you've had a severe reaction to Temozolomide or similar drugs before, or if you have severe bone marrow problems. Certain other serious or uncontrolled medical conditions, or a history of some other cancers, might also prevent you from joining.
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 65 years old or older?
- Have you recently been diagnosed with glioblastoma?
- Has your doctor told you your tumour has the 'unmethylated MGMT' marker?
- Have you completed the usual 3 weeks of radiation with Temozolomide chemotherapy?
- Are you generally well enough to participate in a clinical study?
- Can you have MRI scans?
What does participation involve?
If you decide to take part in this study, you will be given the chemotherapy drug Temozolomide every day for a period. The exact schedule will be explained by your medical team. You will have regular visits to the hospital for checks, which will include blood tests to monitor your health and how you are tolerating the treatment. You will also have regular MRI scans to see how the treatment is affecting the cancer.
The study involves ongoing assessment; the total duration of your participation will depend on how you respond to the treatment and will be discussed in detail with you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.
Potential risks and benefits
Locations (1)
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada· Recruiting
Common questions
What is glioblastoma?
Glioblastoma is a very aggressive type of brain cancer that grows quickly.
What does 'unmethylated MGMT' mean?
It's a specific feature in some glioblastoma tumours that means standard chemotherapy might not work as well, so different treatments are explored.
Is this a new drug?
No, Temozolomide is an existing chemotherapy drug. This study is testing a new way of giving it.
What is a Phase 2 study?
Phase 2 means it's an earlier stage of research, testing if a treatment works and is safe in a small group of patients.
Will I still get my usual care?
Yes, if you decide to leave the study, your medical team will continue to provide your usual standard care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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