"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at bevacizumab and chemotherapy for children and young people with neuroblastoma (BEACON -Neuroblastoma)
This trial is looking at bevacizumab, temozolomide, irinotecan and topotecan for neuroblastoma that isn’t responding to treatment or has come back. The trial is supported by Cancer Research UK.
More about this trial
This trial is for children and young people up to and including the age of 21. We use the term 'you' in this summary, but if you are a parent, we are referring to your child.
Doctors can use different treatments for neuroblastoma including surgery, chemotherapy and radiotherapy.
But sometimes neuroblastoma gets worse despite having treatment. And even if it responds well to treatment to begin with, it may come back later on. In this situation, there are different treatments that doctors can use. Temozolomide with either irinotecan or topotecan are chemotherapy drugs they may use. But they don’t really know if having these drugs together is better than having temozolomide alone.
Researchers also want to find out if having a drug called bevacizumab can help children with neuroblastoma. Bevacizumab is a type of biological therapy called a monoclonal antibody that targets the tumour’s blood supply. Doctors can already use bevacizumab to treat a number of adult cancers. It is now being looked at in trials to see if it works in children.
The aims of this trial are to
- Find out whether having irinotecan or topotecan as well as temozolomide helps children and young people with neuroblastoma that isn’t responding to other treatment or has come back afterwards
- See if adding bevacizumab to chemotherapy helps children and young people in this situation
- Learn more about the side effects of the different drug combinations
Who can enter
You may be able to enter this trial if you
- Have neuroblastoma that has come back or neuroblastoma that isn’t responding to treatment – your doctor can explain this to you
- Have neuroblastoma that doctors can see and measure on a scan
- Are at least 1 year old but have not yet reached your 22nd birthday
- Have satisfactory blood test results
- Are willing to use reliable contraception during the trial and for 6 months afterwards if you are sexually active and there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have neuroblastoma that has grown into a major blood vessel
- Have neuroblastoma that has spread to your brain and is causing bleeding – you can take part if it has spread to your brain as long as it isn’t bleeding
- Have already had bevacizumab, irinotecan or temozolomide
- Have had major surgery in the last 4 weeks
- Have had radiotherapy or chemotherapy in the last 2 weeks
- Have had targeted radiotherapy called MIBG in the last 6 weeks
- Have had a stem cell transplant using your own cells in the last 8 weeks or a transplant using donor cells in the last 3 months
- Have had an experimental drug in the last 2 weeks
- Have had a
biopsyin the last week
- Have high blood pressure that can’t be controlled with medication
- Have certain heart problems – the trial team can advise you about this
- Are known to be very sensitive to anything in the trial drugs or to drugs made in a similar way
- Have ever had an abscess in your tummy (abdomen), a split in the wall of your bowel or an abnormal opening called a fistula in your abdomen
- Have had bleeding in your stomach or gut in the last 6 months
- Have problems with bleeding or are at increased risk of bleeding
- Have had a stroke or a blood clot in a blood vessel called an artery
- Have taken certain drugs to prevent fits (seizures) in the last few days – the trial team can advise you about this
- Are planning to have a
- Have any other medical condition that the trial team think could make it unsafe for you to take part
- Are pregnant of breastfeeding
This is a phase 2 trial. The doctors need around 160 children and young people to take part.
It is a randomised trial. The children and young people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
There are 6 possible treatments
- Temozolomide alone
- Bevacizumab and temozolomide
- Irinotecan and temozolomide
- Bevacizumab, irinotecan and temozolomide
- Temozolomide and topotecan
- Bevacizumab, topotecan and temozolomide
Depending on which group you are in, you have either 3 week or 4 week cycles of treatment. The trial team will explain exactly when you have the drugs in each treatment cycle.
Bevacizumab,irinotecan and topotecan are drugs that you have through a drip into a vein. Temozolomide is a tablet that you swallow.
You have up to 6 cycles of treatment. If your neuroblastoma stays the same size, gets smaller or disappears in this time, and you aren’t having bad side effects, the trial team may talk to you about having up to 6 more cycles of treatment.
During the trial, the team will take some extra blood samples to look for biomarkers. These are substances that doctors can measure to help them tell how a disease is developing or how a treatment is working. They will also get a sample of your tumour that was removed when you had surgery or a biopsy in the past. And if you have any more surgery as part of your neuroblastoma treatment, they will ask for another sample of the tumour.
Before you start treatment, they will ask if you wish to give an optional sample of saliva or blood that they can use to study your DNA.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine test
- Heart scan (
- Bone marrow test
- CT scan or MRI scan
- MIBG scan or PET-CT scan
- An X-ray of your left hand and wrist
During treatment, you see the trial team and have regular blood tests. You have a scan after every 2 cycles of treatment. You may have more bone marrow tests if you had neuroblastoma cells in your bone marrow at the beginning of the trial.
When you finish treatment, you see the trial team again. You have a physical examination, blood tests, urine tests, and another X-ray of your hand and wrist. You also have a CT or MRI scan and a PET-CT or MIBG scan. You may need to have another bone marrow test.
As only a small number of children have had bevacizumab so far, there may be side effects we don’t know about yet. In adults, the most common side effects include
- High blood pressure
- Feeling sick
- Tiredness (fatigue)
- Pain in your joints, muscles, chest or tummy (abdomen)
- Numbness or tingling in your fingers or toes (peripheral neuropathy)
- Slow wound healing
- Protein in the urine
- An increased risk of bleeding
- Poor appetite
Doctors don’t know if bevacizumab could affect bone growth. The trial team will monitor the growth of the children taking part and the X-rays of your hand and wrist also check this.
The most common side effects of irinotecan include
- Diarrhoea which can be severe
- Changes to the way your liver works
- Temporary hair loss
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
The most common side effects of topotecan include
- Feeling or being sick
- A drop in blood cells
- Tummy pain, diarrhoea or constipation
- High temperature (fever)
- Poor appetite
- Hair loss
- Itchy skin
The possible side effects of temozolomide include
- Feeling or being sick
- A drop in blood cells
- Swelling of your gums
- Weight loss
- Hair loss
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.
Dr Lucas Moreno
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Imagine for Margo
NIHR Clinical Research Network: Cancer
University of Birmingham
This is Cancer Research UK trial number CRUK/11/056.