"He went through six operations and was placed on a clinical trial so he could try new treatments.”
A trial of hydroxychloroquine (HCQ) with radiotherapy for high grade gliomas in people aged 70 or over
This trial is looking at adding a drug called hydroxychloroquine (HCQ) to radiotherapy as treatment for a type of brain tumour called a high grade glioma in people aged 70 or over. The trial is supported by Cancer Research UK.
Doctors usually treat high grade gliomas with surgery and radiotherapy. Some people also have chemotherapy. But chemotherapy is not
Doctors use hydroxychloroquine (HCQ) to treat other diseases such as malaria and rheumatoid arthritis. But recent research has suggested it may also help people with certain types of cancer to live longer.
The aims of this trial are to
- Find out if having HCQ as well as surgery and radiotherapy helps people aged 70 or over who have a high grade glioma
- Learn more about the side effects
Who can enter
You may be able to enter this trial if you
- Have had a biopsy or surgery and been diagnosed as having a high grade glioma
- Are at least 70 years old
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Can start radiotherapy within 4 weeks of having surgery
- Have scored more than 17 out of 30 in a memory test doctors often use, called the Mini Mental Status Exam
You cannot enter this trial if you
- Have already had radiotherapy, chemotherapy, biological therapy, hormone therapy or an experimental drug for your brain tumour
- Have had any other cancer in the last 5 years apart from very early stage cancer (
carcinoma in situ) that was successfully treated or basal cell skin cancer
- Have a skin complaint called psoriasis, unless it is treated by a specialist and is well controlled with medication
- Have had eye problems called macular degeneration or diabetic retinopathy – your doctor can advise you about this
- Have a condition called porphyria which can make you very sensitive to light
- Are lacking a body protein called G6PD – your doctor can advise you about this
- Have alcoholic liver disease
- Have a bad infection, any other serious medical condition that can’t be controlled with medication or a mental health problem that the study team think could affect you taking part
- Take a heart drug called amiodarone or drugs that can affect body substances called cytochrome P (CYP) enzymes – your doctor can advise you about this
- Have had side effects from a drug called chloroquine (or a similar drug)
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.
After surgery or a biopsy, you see the trial team and have some tests. The tests include
- Physical examination including an eye test
- Blood tests
- Heart trace (
- MRI scan of your brain
If you are in the HCQ group, you have a more detailed eye test before you start the tablets.
During your radiotherapy treatment you see the trial team once a week. After your radiotherapy, you see them once a month for 3 months and then every 2 months until your brain tumour starts to grow again.
Everybody taking part in the trial has an MRI scan 12 weeks after finishing radiotherapy. People in the HCQ group also have a heart trace 4 weeks after finishing radiotherapy, and eye tests after 3 months, 6 months and 18 months. Then once a year for the whole time you are taking the HCQ tablets.
If you take part in the PET-MRI sub study, you have 4 more hospital visits for the extra scans.
The possible side effects of hydroxychloroquine (HCQ) include
- Changes to your eyesight such as blurred vision
- Low blood sugar (hypoglycaemia)
You must tell your doctors if you have either of these side effects.
If you notice changes to your eyesight, you must stop taking the tablets straight away,
HCQ tablets can affect the way diabetic drugs such as metformin and insulin work. And the diabetic drugs can also affect the way the HCQ tablets work. If you take drugs for diabetes and have low blood sugar a number of times then you might need to stop the HCQ tablets. Your doctors will advise you about this and how often you will need to check your blood sugar.
Other side effects of HCQ include
- Feeling sick
- Stomach pain
- Skin rash or itchy skin
You must also tell your doctor if you have any of these.
If you are male and in the HCQ group, you must use reliable contraception during the trial and for 6 months after finishing the tablets if there is any chance your partner could become pregnant.
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.
Professor Susan Short
Cancer Imaging Centre
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUK/11/057.