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:

Brain (and spinal cord) tumours

Children's cancers

Status:

Closed

Phase:

Phase 1/2

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.

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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 DNA Open a glossary item 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:

06/02/2017

Recruitment end:

17/05/2019

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.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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)