Phase Ib Clinical Trial to Evaluate the Safety Profile of the Combination Tilray FS Oral Solution T10:C10 with Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma.
This research study is for adults newly diagnosed with glioblastoma, a type of brain cancer. It's a Phase 1 study, which means the main goal is to check the safety of a new combination treatment. Patients will receive a cannabis-based medicine (Tilray FS Oral Solution T10:C10) alongside their usual treatments of chemotherapy (temozolomide) and radiotherapy. The researchers want to understand if these treatments can be given together safely and what potential side effects might occur. This is an early stage of research, so they are not yet looking at how well the treatment works, but gathering important information about its safety.
At a glance
What is this study about?
This study is looking into a new way to treat glioblastoma, which is a serious type of brain cancer. When someone is diagnosed, they usually receive treatments like chemotherapy (using medicines to kill cancer cells, in this case, temozolomide) and radiotherapy (using high-energy rays to kill cancer cells). This study explores adding a cannabis-based medicine, called Tilray FS Oral Solution T10:C10, to these standard treatments.
Because this is an early-stage study, called Phase 1, the most important thing the researchers want to find out is if it's safe to give the cannabis-based medicine at the same time as chemotherapy and radiotherapy. They will also be carefully watching for any side effects and how people feel during the treatment. This will help them decide if it's a good idea to continue researching this combination in the future.
The idea is to see if combining these treatments could eventually offer a new approach for people with glioblastoma. By understanding the safety first, doctors can then, in later studies, find out if it can also help to treat the cancer itself more effectively. It’s a step-by-step process in discovering new potential medicines.
Key takeaways
- This study is for adults with newly diagnosed glioblastoma.
- It tests the safety of a cannabis-based medicine combined with standard treatments.
- It's a Phase 1 study, so safety is the main focus.
- Patients will receive existing chemotherapy and radiotherapy plus the new medicine.
- Regular hospital visits for monitoring will be required.
- You can stop participating at any time.
Who may be eligible?
This study is open to adults aged 18 or older who have been recently diagnosed with glioblastoma. Both men and women can take part. The doctors will need to check your general health and that your glioblastoma meets certain criteria for the study.
There will be specific health checks and tests to make sure that taking part in the study is safe for you. For example, if you have certain other medical conditions or are taking particular medications, you might not be able to join. The study team will review all your medical information carefully to see if you are a good fit.
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 recently diagnosed with glioblastoma?
- Are you able to receive standard chemotherapy (temozolomide) and radiotherapy?
- Are you healthy enough to take part in a study?
- Are you free from other serious medical conditions that would prevent participation?
- Are you taking any medications that might interact badly with the study drug?
What does participation involve?
If you decide to take part, you'll receive the cannabis-based medicine as a liquid to take by mouth, alongside your usual chemotherapy and radiotherapy. You will have regular appointments at the hospital for check-ups, blood tests, and scans. These visits are important for the doctors to monitor your health, check for any side effects, and see how you are responding to the treatment.
The study will involve several visits over a period of many months, starting from your diagnosis and continuing through your treatment and for some time afterwards to see how you are doing. The exact number and frequency of visits will be explained by the study team, but they are designed to ensure your safety and collect all necessary information. You will also be asked about any side effects you experience.
Potential risks and benefits
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Common questions
What is glioblastoma?
Glioblastoma is a serious type of brain cancer that starts in the brain.
What is a cannabis-based medicine?
It's a medicine derived from the cannabis plant. In this study, it's called Tilray FS Oral Solution T10:C10.
What does 'Phase 1' mean?
Phase 1 means this is an early study mainly focused on finding out if the new treatment combination is safe, not yet how well it works.
Will I still receive my usual cancer treatment?
Yes, you will receive the cannabis-based medicine in addition to your standard chemotherapy and radiotherapy.
How long will I be in the study?
The study will involve regular visits and monitoring over several months, covering your treatment period and some follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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