This phase 2 trial will recruit 57 people in the UK. It is a randomised trial. After having surgery or a biopsy, 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.
- People in group A have radiotherapy alone
- People in group B have radiotherapy and hydroxychloroquine (HCQ)
There will be twice as many people in the group having HCQ as in the group having radiotherapy alone.
Everybody taking part starts radiotherapy 4 weeks after having surgery or a biopsy. You have treatment 3 days a week for 2 weeks.
If you are in group B, you start taking hydroxychloroquine tablets between 14 and 20 days after your surgery. You must start taking the tablets at least 7 days before your radiotherapy. You take the tablets twice each day. As long as you don’t have bad side effects, you can carry on taking them for as long as they are helping you.
The trial team will ask you to keep a diary to note down when you take the tablets and if you have any problems with them.
The trial team will ask everybody to fill out a questionnaire before starting treatment and a number of times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you have your treatment at University College Hospital (UCH), London, the trial team may ask you to give an extra blood sample and some hair samples. They take the hair samples from the area of your head where you have radiotherapy. These can help researchers to learn more about the effects of your treatment. If you have radiotherapy alone, the trial team will take hair samples once, after you finish your treatment. If you are in the group having HCQ, they take hair samples twice – once before you start radiotherapy and then again after you finish radiotherapy.
The researchers at UCH will also ask some people in the group having HCQ to take part in a sub study looking at a new type of scan called PET-MRI. This is a way of having 2 different types of scan at the same time – a PET scan and an MRI scan. The study team want to find out if PET-MRI scans are better than MRI scans at diagnosing high grade gliomas and showing how well treatment with HCQ and radiotherapy works.
If your doctor thinks you may have a high grade glioma, a team of specialists decide whether you should have a biopsy or surgery to remove the tumour. The people taking part in the sub study will be having a biopsy rather than surgery to remove their tumour.
The study team will talk to people about joining this sub study before they have their biopsy. If you agree to take part, you have a PET-MRI scan before your biopsy. They will then ask 10 people in the HCQ group to have 3 more PET-MRI scans. These will be
- After your 2nd radiotherapy treatment
- After your 5th radiotherapy treatment
- 12 weeks after you finish radiotherapy
You don’t have to take part in this sub study if you don’t want to. You can still take part in the main trial.
