A trial of vinblastine and nilotinib for children and young people with a brain tumour (VINILO)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is for children and young people who either:
- have a low grade glioma that has come back (recurred) or continued to grow despite treatment (
refractory 
) - have a newly diagnosed low grade glioma and a condition called
neurofibromatosis type 1
It is for children and young adults aged between 6 months old and 21 years old. We use the term ‘you’ in this summary. But if you are a parent, we are referring to your child.
Cancer Research UK supports this trial.
More about this trial
Low grade gliomas are brain tumours that start in the glial cells of the brain. They are usually slow growing tumours.
Treatment for a low grade glioma depends on where the tumour is and the age of the child or young person. A common treatment is a chemotherapy drug called vinblastine (Velbe).
In this trial, doctors are looking at a targeted drug called nilotinib (Tasigna). Nilotinib blocks a protein that stimulates cancer cells to grow. It is already a possible treatment for people with a type of leukaemia called chronic myeloid leukaemia (CML). Doctors think that it can also help children and young adults with low grade glioma.
This trial is in 2 parts. In the first part, doctors looked for the highest dose of nilotinib that you can safely have with vinblastine. This part of the trial is closed. Doctors are now looking for people to join the 2nd part.
Everyone joining the 2nd part of this trial has 1 of the following:
- vinblastine
- vinblastine and nilotinib
The main aim of this trial is to find out whether vinblastine and nilotinib is better than vinblastine alone for children and young people with low grade glioma.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if 1 of the following applies.
- You have low grade glioma that has come back or continued to grow after at least 1 type of treatment. You may or may not have neurofibromatosis type 1
- You have low grade glioma and neurofibromatosis type 1. And you are going to have treatment with chemotherapy for the first time
As well as one of the above, all of the following must apply:
- you are aged between 6 months old and 21 years old
- you are able to care for yourself but not able to carry on with all your normal activities or do your active work (Karnofsky performance status 70 or more). Or your child can’t play as energetically as normal and spends less time than usual in play activity (Lansky play scale 70 or more). If you are in a wheelchair but are otherwise well you can enter the trial
- you have a tumour that can be seen and measured on an MRI scan
- you have satisfactory blood tests results
- you are willing to use reliable contraception during treatment and for 3 months afterwards if you are sexually active and there is any chance that you or your partner could become pregnant
- your heart is working well
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
- are having other cancer treatments
- have had vincristine in the past 2 weeks
- have had treatment with chemotherapy in the last 3 weeks (6 weeks if it was a drug called
nitrosourea) - have had radiotherapy in the last 6 weeks
- still have moderate or severe side effects from previous cancer treatment
Medical conditions
You:
- have taken steroids in the past week, unless it was a stable dose
- have an active infection
- have problems with your
digestive system that can affect how you absorb capsules - take drugs that affect your heart or an enzyme called CYP3A4 (your doctor can tell you more about this)
- have hepatitis B
- are sensitive to vinblastine
- have any other medical condition that doctors think could affect you taking part
Trial design
This is an international phase 1/2 trial. Researchers need up to 172 children and young adults to take part.
This trial is in 2 parts. In the first part, doctors looked for the highest safe dose of nilotinib that you can have with vinblastine. This part of the trial is closed. Doctors are now looking for 122 children and young adults to join the second part.
The 2nd part of this trial is randomised. This means that everyone is put into 1 of the following treatment groups by computer:
- vinblastine
- vinblastine and nilotinib
Neither you nor your doctor can choose which group you join.
Vinblastine
You have vinblastine as a drip into your vein every week. You have it for as long as it is helping you and the side effects aren’t too bad. It can be for up to a year.
Nilotinib
Nilotinib comes as capsules that you swallow whole, twice a day. You should wait at least 2 hours after eating before taking them. And after you have taken them, don’t eat for an hour afterwards.
You continue to take nilotinib for as long as it helps and the side effects aren’t too bad. It can be for up to a year.
Doctors will ask you to keep a diary to record each time you take nilotinib. This helps your doctor know how many doses of treatment you have had.
Blood tests
You might have extra blood tests as part of this trial. Researchers want to find out what happens to nilotinib and vinblastine in your body.
You have the extra blood tests a week after you start treatment. You may need to stay in hospital overnight to have them. Your doctor can tell you more about this.
Tissue sample
The trial team will ask to use a sample of your cancer taken at the time of your diagnosis. Doctors want to look at the cancer and find out why treatments work better for some people than others.
Hospital visits
You see a doctor and have some tests before taking part. The tests might include:
- a physical examination
- blood tests
- urine test
- an eye test
- MRI scan
- a test of your nervous system (a neurological examination)
- heart trace (
ECG ) and heart ultrasound (ECHO )
During treatment, you see the trial team every week for blood tests and a physical examination.
You may have an MRI scan 4 weeks after the start of treatment. You then have an MRI scan every 12 weeks.
This continues for as long as your cancer stays the same and the side effects aren’t too bad. It can be for up to a year.
When you finish treatment, you see the trial team after a month. You then continue to see your doctor as part of your normal follow up. This is usually every 3 to 4 months.
Side effects
The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about the possible side effects before you start the trial.
The most common side effects of vinblastine are:
- a drop in the number of blood cells increasing your risk of infection, tiredness and breathlessness and bleeding
- feeling or being sick
- constipation or diarrhoea
- loss of appetite
- hair loss
- skin problems such as blisters
- numbness or tingling in fingers and toes
- hearing loss
- mood changes such as depression
- heart problems such as high blood pressure
- pain in your tummy, bones and muscles
- mouth ulcers
- dizziness
The most common side effects of nilotinib are:
- tiredness (fatigue) during and after treatment
- a drop in the number of blood cells increasing your risk of infection, tiredness and breathlessness and bleeding
- headaches
- feeling or being sick
- constipation or diarrhoea
- pain in your tummy, joints and muscles
- hair loss
- skin rashes and itchy skin
- problems with your liver and pancreas
- a drop in the levels of phosphate in your body
We have more information about the possible side effects of vinblastine and nilotinib.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Susan Picton
Supported by
Cancer Research UK
Institute Gustave-Roussy
The Brain Tumour Charity
International Society of Paediatric Oncology (SIOP)
Innovative Therapies for Children with Cancer European Consortium (ITCC)
Other information
This is Cancer Research UK trial number CRUK/13/011
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
