Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas
This research study is for children and young adults, aged 25 or younger, who have a type of brain tumour called low-grade glioma that has come back or grown. The study specifically looks at tumours that have certain genetic changes (called CRAF or BRAF alterations). Doctors are testing a combination of two existing medicines, tovorafenib and vinblastine, to see if they work better together. The study has two main parts: first, finding the best and safest dose of the combined medicines, and then checking how well that dose works. Taking part means regular hospital visits, scans, and blood tests over a period of up to two years, with medicine taken weekly.
At a glance
What is this study about?
This study is a research project for children and young adults, up to 25 years old, who have a type of brain tumour called low-grade glioma. These tumours are usually slow-growing, but in this specific study, the tumour has either returned after previous treatment or has started to grow again. Importantly, the study is looking at tumours that have specific genetic changes within them, known as CRAF or BRAF alterations. These changes can sometimes make the tumour behave differently.
The main goal of this study is to see if combining two medicines, tovorafenib and vinblastine, can be an effective treatment for these specific low-grade gliomas. Tovorafenib is a newer drug that targets the genetic changes, while vinblastine is a more established chemotherapy medicine. The doctors want to find the right balance of these medicines to ensure they are both effective and safe for patients.
To do this, the study is split into two phases. The first phase focuses on finding the best dose of the combined medicines. Once that dose is identified, the second phase will then test how well this combination works for a larger group of patients. This careful approach helps researchers understand the new treatment step-by-step.
Key takeaways
- This study is for young people (up to 25) with low-grade glioma that has returned or grown.
- It tests two medicines together: tovorafenib and vinblastine.
- The study focuses on tumours with specific genetic changes called BRAF or CRAF alterations.
- Participation involves weekly medication and regular hospital visits for about two years.
- Scans will be done every three months to monitor the tumour's response.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you must be 25 years old or younger. You need to have been diagnosed with a low-grade glioma that has either come back or gotten worse, and your tumour must have specific genetic changes called BRAF or CRAF alterations. Doctors will check for these changes using tests.
Your tumour must also have been confirmed by a pathologist and show signs of growth or recurrence. You will also need to have received at least one course of treatment for your glioma before, and have recovered from any serious side effects of those treatments. There are also specific timeframes for when you last received chemotherapy or radiation.
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 25 years old or younger?
- Has your low-grade glioma come back or started growing again?
- Do your tumour tests show BRAF or CRAF genetic changes?
- Have you had at least one other treatment for your glioma before?
- Have you recovered from any serious side effects of your past treatments?
What does participation involve?
If you decide to take part in this study, you will receive the combination of vinblastine and tovorafenib. Both medications will be given weekly for the first 17 cycles, with one cycle lasting 28 days. After these initial 17 cycles (approximately 16 months), you will continue taking only tovorafenib for an additional 7 cycles (about 7 months). The total treatment period is up to 24 cycles, which is roughly two years, unless your tumour gets worse or you experience side effects that make continuing difficult.
Throughout the study, you will have regular hospital visits for check-ups, blood tests, and to receive your medication. Every three cycles (around every three months), you will have scans to see how your tumour is responding to the treatment. It's important to know that if you miss a dose of either medicine, it won't be made up. You can stop participating in the study at any time.
Potential risks and benefits
Locations (1)
- The Hospital for Sick ChildrenVerified postcodeToronto, Canada· Recruiting
Common questions
What is a low-grade glioma?
It's a type of brain tumour that usually grows slowly, but in this study, it has either come back or started to grow again.
What are BRAF or CRAF alterations?
These are specific genetic changes found in some tumours that the study is targeting with the new treatment.
How long will the study treatment last?
The treatment could last for up to two years, involving weekly medication and regular check-ups.
Will I have scans during the study?
Yes, you will have scans approximately every three months to see how your tumour is responding.
Can I stop being part of the study?
Yes, you can choose to withdraw from the study at any time, for any reason.
How to find out more
Nirav Thacker
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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