An open-label dose escalation study to estimate maximum tolerated dose (MTD), identify dose-limiting toxicities (DLTs) and study pharmacokinetics following a single dose of intracranially administered temozolomide-based SI-053 as an add-on to the current standard of care (SoC), in adult patients with newly diagnosed glioblastoma (GBM).
This research study is looking at a new treatment approach for adults who have recently been diagnosed with glioblastoma, a serious form of brain cancer. The study involves a new way of giving an existing cancer medicine called temozolomide directly into the brain, alongside the usual treatments patients receive. The main goal is to find the highest safe dose of this new treatment method. Researchers will closely watch for any side effects and how the body handles the medicine. This is a very early-stage study, meaning it's the first time this specific treatment method is being given to people, to make sure it's safe before moving on to larger studies.
At a glance
What is this study about?
This study is looking into a new way to treat adults who have recently been diagnosed with glioblastoma, which is a type of brain cancer. The main idea is to deliver a medicine called temozolomide directly into the brain. Temozolomide is a chemotherapy drug already used for glioblastoma, but this new method, called SI-053, is designed to get the drug right where it's needed most in the brain. This is given in addition to the standard treatments that patients usually receive for their glioblastoma.
The main purpose of this study is to find the safest and most effective dose of SI-053. Because this is a new way of giving the medicine, researchers need to start with very small doses and gradually increase them, carefully watching for any side effects. They also want to understand how the body processes this new form of the medicine when it's given directly into the brain.
This kind of study is called a 'Phase I' study. This means it's one of the very first times this specific treatment method is being tested in people. The main goal at this stage isn't to cure the cancer, but to ensure the treatment is safe and to find the best dose to use in future, larger studies. The information gathered from this study will be very important for developing better treatments for glioblastoma in the future.
Key takeaways
- This study is for adults with newly diagnosed glioblastoma (a type of brain cancer).
- It's testing a new way to give an existing cancer medicine (temozolomide) directly into the brain.
- The main goal is to find the safest dose of this new treatment when taken with standard care.
- This is a very early-stage (Phase I) study, focusing on safety and finding the right dose.
- You would receive the new treatment in addition to your usual care.
Who may be eligible?
To be considered for this study, you must be an adult, meaning you are 18 years old or older. There is no upper age limit mentioned, so older adults may also be able to take part.
This study is specifically for people who have recently been diagnosed with glioblastoma. You will need to have a confirmed diagnosis of this type of brain cancer.
Both men and women are welcome to participate, as gender is not a factor in who can join this study. Other health checks and assessments will be done by the study team to make sure it is safe for you to take part.
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 recently been diagnosed with glioblastoma?
- Are you able to commit to regular hospital visits and follow-ups?
- Are you currently receiving or going to receive standard treatments for glioblastoma?
What does participation involve?
If you decide to take part in this study, you will receive the new treatment, SI-053, which involves giving the temozolomide medicine directly into your brain. This will be an addition to the standard treatments you would already be receiving for your glioblastoma. The study will involve regular visits to the hospital for checks and to receive the treatment.
During these visits, the study team will closely monitor your health. This will include blood tests, scans, and other assessments to see how you are responding to the treatment and to check for any side effects. The initial part of the study will involve increasing the dose to find the safest level. The total duration of your participation in the study will depend on how you respond to the treatment and the study plan, but there will be a follow-up period to continue monitoring your health.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedNetherlands
Common questions
What is glioblastoma?
Glioblastoma is a serious and fast-growing type of cancer that starts in the brain.
What is 'standard of care'?
Standard of care means the usual, accepted treatments that doctors currently use for a specific condition, like surgery, radiotherapy, and chemotherapy.
What does 'Phase I study' mean?
A Phase I study is the first step where doctors test a new treatment in a small group of people to see if it's safe and to find the right dose.
Will I get better if I join this study?
While the aim is to find better treatments, this early-stage study is mainly to check safety and find the right dose. There's no guarantee it will improve your condition.
What does 'intracranially administered' mean?
This means the medicine is given directly into the brain or skull area.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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