"I am glad that taking part in a trial might help others on their own cancer journey.”
A trial of bevacizumab with radiotherapy and temozolomide for children with a high grade glioma (HERBY)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at adding bevacizumab to radiotherapy and chemotherapy after surgery for children with a type of brain tumour called a high grade glioma. It is for children who have a tumour that isn’t in the hindbrain (cerebellum) or brain stem.
The trial is for children from 3 years old, up to and including the age of 17. We use the term ‘you’, but of course if you are a parent, we are referring to your child.
Doctors usually treat high grade gliomas with surgery followed by radiotherapy and a chemotherapy drug called temozolomide. In this trial, doctors want to see if adding the drug bevacizumab improves treatment.
Bevacizumab is a type of biological therapy called a monoclonal antibody. It works by targeting a protein called vascular endothelial growth factor (VEGF) which helps a tumour to make new blood vessels. All cancers need a blood supply to be able to survive and grow. Blocking VEGF can stop the growth of new blood vessels and slow the growth of a tumour.
Doctors can already use bevacizumab to treat different types of adult cancers. The aim of the study is to see if adding bevacizumab to radiotherapy and temozolomide helps children with high grade gliomas.
Who can enter
You may be able to enter this trial if you
- Have recently been diagnosed with a glioma that is grade 3 or 4 and is above a part of your brain called the tentorium (a high grade supratentorial glioma)
- Are at least 3 years old but haven’t yet reached your 18th birthday
- Had surgery to remove your brain tumour at least 4 weeks ago
- Have satisfactory blood test results
- Are willing to use reliable contraception if you are sexually active
The trial will also recruit a small number of children between the ages of 6 months and 3 years who have a glioma anywhere in the brain that has come back or got worse despite having surgery and chemotherapy.
You cannot enter this trial if you
- Had surgery to remove your glioma more than 6 weeks ago
- Have had bleeding in your brain after surgery and it isn’t getting better
- Have more than one tumour or your glioma has spread into your spinal cord
- Have already had radiotherapy to your brain
- Have already had anti cancer treatment that reaches your whole body (
- Have problems with bleeding or certain heart problems – the trial doctor can advise you about this
- Have an ulcer in your stomach or food pipe (a
- Have a wound or a broken bone that isn’t healing
- Have had any other type of cancer in the last 5 years
- Have an infection
- Can’t take either of the drugs in the trial for any reason
- Are known to be very sensitive to drugs made in the same way as bevacizumab
- Take drugs called aspirin or clopidogrel each day to thin your blood, unless it is a low dose – the trial doctor can advise you about this
- Are pregnant or breastfeeding
This phase 2 trial will recruit about 120 children in different countries. It is a randomised trial. The children 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.
Half the children have radiotherapy and temozolomide. The other half have radiotherapy, temozolomide and bevacizumab.
Everybody taking part has radiotherapy everyday from Monday to Friday for 6 weeks. You take temozolomide tablets every day during this time. You then have a break from the tablets before starting them again 4 weeks later.
When you start taking the tablets again, you have 4 week cycles of treatment. You take temozolomide on the first 5 days of each treatment cycle. You have 12 cycles of treatment, lasting nearly a year.
If you are in the group having bevacizumab, you have this through a drip into a vein. It takes about an hour and a half each time. You have bevacizumab every 2 weeks throughout the whole treatment period.
There is also a small group of children under 3 joining the trial who have a glioma that has come back or got worse despite having surgery and chemotherapy. This part of the trial is not randomised. All these children have temozolomide and bevacizumab in 4 cycles of treatment for or up to a year.
The trial team will ask you (or your parents) to fill out a questionnaire before you start treatment, a number of times during treatment and 3 months after you finish treatment. The questionnaire will ask about how you are. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- MRI scans
- An X-ray of your hand or wrist
The trial team will ask permission to get a sample of your tumour that was removed during surgery. They will use this, along with some extra blood samples to look for substances called biomarkers. These can be measured and show how a treatment is working. But you don’t have to agree to this if you don’t want to. You can still take part in the trial.
When you start treatment, you have radiotherapy every day from Monday to Friday for 6 weeks.
If you are in the group having bevacizumab you go to hospital every 2 weeks throughout your treatment. If you are in the other group, the trial team will want to check how you are every 2 weeks. But they may be able to do this by phone sometimes, so you might have fewer hospital visits than children in the bevacizumab group.
You have regular physical examinations and blood tests during the trial. You have an MRI scan 4 weeks after finishing radiotherapy and then every 3 months for the rest of your treatment.
When you finish treatment, you see the trial team again every 3 months for 2 years. At each visit, you have a physical examination, blood tests, a urine test, an MRI scan and an X-ray of your hand or wrist to see if the treatment has affected your bone growth. If you have already stopped growing, you don’t need to have these X-rays.
The trial team will ask you to fill out another questionnaire 3 months and 2 years after finishing treatment. These questionnaires measure your IQ score.
The most common side effects of bevacizumab include
- High blood pressure
- Numbness or tingling in your fingers or toes
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Bleeding from the back passage (the rectum)
- Feeling or being sick
- Pain such as headache and joint pain
- Sore mouth
- Protein in the urine
- Tiredness (fatigue)
- Loss of appetite
- High temperature (fever)
- Runny nose and nose bleeds
- Dry skin
- Changes to your sense of taste
- Eye problems
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.
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer