A trial of targeted drugs and chemotherapy for children and young people with cancer (eSMART)

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. 

In this trial there are several different treatments that you might be able to have. 

This is a list of the general entry conditions for this trial. There are other conditions for each treatment that will apply for you to be able to join or others that might mean you can’t join. Your doctor or the trial team will talk to you about these. 

Who can take part

You may be able to join this trial if all of the following apply. You:

• have cancer that has got worse after standard treatment or there is no standard treatment available
• gave a sample of cancer tissue (biopsy) for the SMPaeds programme that looks for certain changes (mutations) in the cells’ DNA 
• have an area of cancer that can be seen and measured on a scan
• are 13 years old or older and can care for yourself but may not be able to do your normal activities (Karnofsky performance score of 70 or more) or you are 12 years old or younger and you don't play as energetically as usual and you might spend less time than usual in active play (Lansky performance score of 70 or more)
• have satisfactory blood test results
• have had heart tests that show your heart is working well enough (this is only if your previous treatment could affect the heart)
• can swallow capsules if the drug you have in the trial is a capsule
• are at an age where you are sexually active and you are willing to use reliable contraception during treatment and for up to 7 months after if you or your partner could become pregnant
• are up to 17 years old, if you are 18 years old or older you might be able to join the trial if you were diagnosed with cancer when you were younger and now it has come back, got worse or treatment isn’t working. Or if your cancer is a cancer type most commonly found in children rather than adults. 

There are also certain other entry conditions for each treatment arm. Your doctor or the trial team will talk to you about these. 

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related
You:

• have cancer spread to the brain or spinal cord that is causing symptoms and you are having treatment to that area or you need increasing doses of steroids. If you are having steroids you must be on the same dose for at least 7 days to join the trial
• have had another cancer treatment within 3 weeks of starting treatment
• have had treatment to kill cells in the bone marrow  followed by a transfusion of your own stem cells (autogenic transplant) within 8 weeks of starting treatment
• have had a stem cell transplant with somebody else’s cell (allogeneic transplant ) within 3 months of starting treatment
• are taking medication to treat or prevent graft versus host disease (GVHD ) after a bone marrow transplant
• have had radiotherapy within 3 weeks of starting treatment. Or within 6 weeks for mIBG or radiotherapy to the head or spine.
• have ongoing moderate to severe side effects from previous treatment apart from hair loss, loss of hearing and nerve damage (peripheral neuropathy)

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

• have problems with your digestive system  such as ulcerative colitis, feeling or being sick or diarrhoea that could affect you well your gut absorbs medication
• have severe heart problems within the past 12 months that aren’t controlled by medication
• have an active hepatitis infection 
• have HIV
• have an infection that needs treating
• have had major surgery within 3 weeks of starting treatment
• are taking medication that could affect how your heart beats 
• are taking medication that affects the CYP enzymes unless it can be stopped a week before starting treatment and not taken during the trial

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

• are allergic to the drugs used in this trial or any of their ingredients
• have a live vaccine  within 4 weeks of starting treatment
• are pregnant or breastfeeding

There are also other conditions for each treatment arm which might mean you are not be able to join the trial. Your doctor or a trial team member will talk to you about them.