"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of bevacizumab with chemotherapy for children and teenagers who have soft tissue sarcoma that has spread (BERNIE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at bevacizumab alongside chemotherapy for soft tissue sarcoma that has spread to another part of the body (metastatic sarcoma). Bevacizumab is also known as Avastin.
The trial is for children and teenagers up to the age of 18 who have not had any other treatment for soft tissue sarcoma after it has spread. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.
Bevacizumab is a type of biological therapy called a monoclonal antibody. The aim of this trial is to see if having bevacizumab alongside chemotherapy is better than chemotherapy alone for children and young people with soft tissue sarcoma that has spread.
Who can enter
You may be able to enter this trial if you
- Are at least 6 months old but less than 18 years old
- Have soft tissue sarcoma that has spread from where it started to elsewhere in your body
- Have satisfactory blood test results
- Are willing to use a reliable form of contraception 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 sarcoma that has spread to your brain or spinal cord, or that is pressing on your spinal cord (spinal cord compression)
- Have sarcoma that is growing into a large blood vessel
- Have had any other cancer treatment that reaches your whole body (
- Need to have surgery or radiotherapy straight away – your doctors can advise you about this
- Have a wound or broken bone that has not healed
- Have an ulcer in your stomach or gut (
- Have had an experimental drug or taken part in another clinical trial in the last month
- Have a high risk of bleeding – the trial doctors can advise you about this
- Have any other medical condition that the trial team think could affect you taking part in this study
- Are known to be very sensitive to any of the drugs included in this study or to other monoclonal antibodies
- Take daily aspirin or a drug called clopidogrel to prevent blood clots
- Have had any other type of cancer
- Are pregnant or breastfeeding
This is a phase 2 trial. It will recruit about 150 children and teenagers. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by computer. Neither you nor your doctor can decide which group you are in.
Half the people taking part have bevacizumab alongside chemotherapy. The other half have chemotherapy alone.
The chemotherapy in this trial takes about 18 months all together and is in different phases. The first phase is called induction therapy and lasts about 6 to 7 months. You have drugs called ifosfamide, vincristine, and Actinomycin D. This treatment plan is called IVA. You have IVA in 3 week cycles of treatment. In the first 4 treatment cycles, you also have a drug called doxorubicin. You have all these drugs through a drip into a vein.
If you are in the group having bevacizumab, you have this through a drip into a vein once in each treatment cycle. You have it on the same day as your chemotherapy.
Everybody taking part has 9 cycles of induction chemotherapy all together. After about 6 cycles of treatment, your doctors will talk to you about whether or not you need to have radiotherapy or surgery (or both). If you have surgery, this will be after the 6th cycle of chemotherapy. If you have radiotherapy, this will start at the same time as the 8th cycle of chemotherapy.
You have vinorelbine through a drip into a vein 3 times in each cycle. You take cyclophosphamide as tablets every day. If you are in the group having bevacizumab, you have it once every 2 weeks during this phase. As before, you have it through a drip into a vein on the same day as you have chemotherapy.
When you finish the maintenance therapy, you move into the follow up phase of the trial which lasts for at least 4 years. You don’t have any more treatment, but the researchers monitor you for any signs of your sarcoma coming back.
The trial team will ask to take extra blood samples before you start treatment and then 6 times during the study. They will use these samples to look for substances called biomarkers, which can help to show doctors how well a treatment is working. You don’t have to give these samples for research if you don’t want to.
You will see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests and urine tests
- CT scan or MRI scan
- Bone marrow test
- Heart ultrasound (
- Lumbar puncture
The researchers will also take a sample of your sarcoma (a
During induction therapy, you go to hospital on 3 or 4 days in each 3 week treatment cycle. During the maintenance phase, you go to hospital 3 times in each 4 week cycle.
Throughout your treatment, you have regular blood tests and urine tests. You have a scan every 3 months.
During the follow up phase, you have hospital visits about once every 3 months for 18 months, then once every 6 months for the next 2½ years.
The common side effects of chemotherapy include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Loss of appetite and weight loss
- Sore mouth
- Diarrhoea or constipation
- Hair loss
The side effects of bevacizumab include
- High blood pressure
- Allergic reaction
- Kidney problems
- Heart problems
- Delayed wound healing
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 Julia Chisholm
European Paediatric Soft Tissue Sarcoma Study Group (EpSSG)