A trial looking at treatment for children and young people with neuroblastoma that has come back after treatment (BEACON2)

The following bullet points are a summary of 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 all of the following apply. You:

• have neuroblastoma
• have high risk neuroblastoma that has come back after treatment (relapsed) or got worse 
• have neuroblastoma that your doctor can measure on a scan . You can’t take part if you only have neuroblastoma that shows up on a bone marrow test . 
• can care for yourself, you may need help from time to time or you need a lot of help to look after yourself. (Karnofsky performance status 50 or more). Or your child plays actively, may not play as energetically as normal or takes part in quiet play and activities (Lansky play scale 50 or more). If you are in a wheelchair but are otherwise well you can enter the trial.
• have satisfactory blood test results 
• have satisfactory blood pressure measurements for your age. Your doctor will check this. You can take part if you take medication to control your blood pressure.
• are at least one year old 
• are willing to use reliable contraception during the trial and for a period after if you are sexually active and there is any chance you or your partner could become pregnant 

As well as the above, to join part two the following must apply:

• you have neuroblastoma that has come back more than once or you aren’t suitable to join part 1. Your doctor will know about this.

Who can’t take part

Cancer related 
You cannot join this trial if any of these apply. You:

• have had treatment that included chemotherapy, dinutuximab beta or a similar drug in the last 2 weeks, craniospinal radiotherapy or mIBG radiotherapy in the last 6 weeks, radiotherapy to the area of cancer in the last 2 weeks, a stem cell transplant  with your own cells in the last 8 weeks or with somebody else's cells in the last 3 months. Or you have had an experimental treatment in the last 2 weeks. 
• have areas of cancer spread elsewhere in the body that are bleeding. If you had this problem it must be at least 6 months since you last had any bleeding from these areas of cancer.

Medical conditions
You cannot join this trial if any of these apply. You:

• have significant side effects that have affected the brain, spinal cord and nerves. These include seizures (fits) or moderate numbness and tingling in the hands or feet. You can take part if you have side effects from previous spinal cord compression  or surgery to treat this. 
• have had a blood clot in the past that blocked an artery and caused a heart attack or stroke or you currently have a blood clot
• have or had inflammation of the lungs that needed steroid treatment 
• are allergic to treatment for a fungal lung infection. This means you can’t have medication used to prevent this. Your doctor will know about this. 
• have an infection that isn’t well controlled with medication 
• have had recent surgery. This includes minor procedures in the last day or 2, or major surgery in the last 2 weeks. 
• have had certain types of medication to prevent seizures (fits) within 3 days of joining the trial
• have a condition that could increase the side effects of bevacizumab. This includes a bleeding problem or you are at risk of this, inflammatory bowel disease or a blocked bowel.
• have moderate amounts of protein in your urine
• haven’t recovered from surgery and you have any moderate to severe problems with wound healing 
• have a problem with how your kidneys work
• have a bleeding problem that isn’t well controlled with medication
• have high blood pressure that isn’t well controlled with medication 
• aren’t on a stable dose of warfarin or medication to stop the blood clotting if you take this. You must be on a stable dose for at least 2 weeks before you join the trial. 
• have any other medical condition that could affect you taking part

Other 
You cannot join this trial if any of these apply. You:

• are allergic to any of the treatments in the trial or anything they contain
• can’t absorb or breakdown certain sugars such as lactose, fructose and galactose
• have had a live vaccine within 28 days of joining the trial. This does not apply to the COVID-19 vaccine or the seasonal flu vaccines as these aren’t live.
• are pregnant or breastfeeding

As well as the above, you can’t join part one if any of the following apply. You: 

• have had neuroblastoma that has come back or got worse more than once after starting treatment for high risk neuroblastoma
• have already had bevacizumab for neuroblastoma that has come back. You can take part if you have had the chemotherapy drugs irinotecan and temozolomide as long as your cancer didn’t get worse during this treatment. 
• have had treatment with dinutuximab beta or a similar drug alongside chemotherapy for neuroblastoma that has come back. You can take part if you had this treatment because the treatment you were having had stopped working (refractory neuroblastoma).