From Cancer UK website:
The trial team will talk to you about joining the trial before you have surgery. This is because they need your permission to get samples of your tumour that they would be able to use to make the vaccine.
Agreeing to this doesn’t mean that you will definitely be able to take part in the trial. Whether or not you can take part depends on the results of MRI scans after surgery and radiotherapy, whether the researchers are able to get enough material from your tumour to make the vaccine, and other factors.
If it turns out that you can’t take part in the trial, the sample of your brain tumour will be used for research, unless you tell the trial team that you want it to be destroyed instead.
If it looks as though you can take part in the trial, the next step is for the researchers to get some of your white blood cells to make the vaccine. The way they do this is described in the hospital visits section below.
You then have radiotherapy and chemotherapy. After finishing radiotherapy, you have another MRI scan to check that your tumour hasn’t started growing again. You can only take part in this trial if your doctors are sure that your tumour hasn’t started to grow again.
Sometimes, it isn’t possible to tell from the results of a scan whether or not a tumour has started growing again. It may look as though there is growth, but it could be swelling (inflammation) or scarring after surgery. If the doctors are unsure what the results are showing, you have another MRI scan 2 months later. If this shows there is no growth, you may then be able to take part in the trial.
The trial is randomised. The 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. And neither of you will know which group you are in. This is called a double blind trial.
For every 3 people who take part, 2 have DCVax-L injections and 1 has a dummy injection (placebo Open a glossary item).
DCVax-L for glioblastoma multiforme trial diagram
You have the vaccine (or dummy) injections under the skin on your upper arm. You have them 3 times in the first month, 4 more times over the next year and then every 6 months until the end of treatment. You have 2 separate injections each time.
If scans show that your tumour starts to grow again during treatment, you can start having DCVax-L injections regardless of the group you are in. This is called a ‘crossover option’. You may have already been having the vaccine, or you may have been having the dummy drug – neither you nor your doctor will know. If you go into the crossover option, you still won’t know which treatment you’d been having up until then. But you will definitely be having the vaccine from then on.
Your doctor will tell you if your tumour has started to grow again and then it is your choice whether you want to definitely start having the vaccine or not.
If you do, you start the treatment from the beginning, so you have the vaccine 3 times in the next month, 4 more times over the next year and then every 6 months. You may have other treatment as well if your doctor thinks it is right for you.
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