A study looking at VCN-01 to treat brain tumours
Cancer type:
Status:
Phase:
This study is looking at the virus VCN-01 to help treat brain tumours.
It is for people who are due to have surgery to remove their brain tumour because:
- the brain tumour has come back after treatment or
- the cancer had spread to the brain from somewhere else in the body
This study is only for people having their care at St James’s Hospital in Leeds.
Cancer Research UK supports this study.
More about this trial
Sometimes brain tumours come back after treatment or cancer spreads to the brain from other parts of the body. It is usual to have surgery to remove these tumours if this is possible. Researchers are looking at ways to improve treatment for these groups of people. In this study they are looking at a virus called VCN-01.
VCN-01 comes from a naturally occurring virus called adenovirus. It can cause symptoms such as coughs, colds and diarrhoea.
VCN-01 has been changed in the laboratory to help it treat cancer. We know from previous research that the changed VCN-01 virus kills cancer cells but doesn’t affect healthy cells.
Researchers aren’t sure how well it will work for brain tumours. So they are doing this study to find out more.
In this study, everyone has an injection of VCN-01 followed by surgery as planned.
The main aims of this study are to find out if:
- VCN-01 can reach brain tumours
- how safe it is to have VCN-01 for brain tumours
- more about the side effects
Please note, you might not get any direct benefit from taking part in this study. It might help people with brain tumours in the future.
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:
- have a grade 3 or grade 4 glioma that has come back or you have a grade 2 glioma that has a high chance of growing quickly. Or you have a
solid tumour (cancer) 
that has spread to the brain from another part of the body. - are going to have surgery to remove the brain tumour
- are fully active but might not be able to do heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- are willing to use reliable contraception if there is any chance you or your partner could become pregnant
- have fully recovered if you have had a recent viral infection
- are at least 16 years old
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
- have side effects from past treatments unless they are mild
- have a condition called
Li-Fraumeni syndrome or you are known to have a fault in the RB1 gene. The RB1 gene can increase the risk of developing a rare type of eye cancer called retinoblastoma. Your doctor will know this. - have had treatment with a live
vaccine or an mRNA vaccine 3 weeks before having VCN-01 or you have these vaccines 2 weeks after having VCN-01 - have had treatment with another experimental treatment or it hasn’t cleared your body yet
Medical conditions
You cannot join this study if any of these apply. You:
- have HIV, hepatitis B or hepatitis C or any other active infection
- have a serious
autoimmune condition - are having treatment that damps down the immune system. This doesn’t include steroids.
- have or your doctor thinks you have a long term
liver problem - have tested positive for COVID-19
- are in close contact with people whose
immune systems don’t work well. This includes people who take medication to damp down their immune system, or who have AIDS. - are having treatment to thin the blood and this can’t be stopped within 2 days of having VCN-01
- have dementia or changes in your mental status that means you can’t give
informed consent to join the study - have any other medical condition or mental health problem that could affect you taking part in the study
Other
You cannot join this study if any of these apply. You:
- have a significant problem with alcohol
- are pregnant or breastfeeding
Trial design
This phase 1 study is only taking place at St James’s hospital in Leeds. The team need about 12 people to join.
Everyone has VCN-01 followed by surgery.
You have one dose of VCN-01. You have this as a drip into a vein 5 to 15 days before your planned surgery to remove the brain tumour.
Your doctor will talk you about your surgery, what this involves and how long you’ll be in hospital for.
Samples for research
The researchers might ask to access a sample of cancer tissue () that was taken when you were diagnosed with a brain tumour. They also ask to take a tissue sample when you have surgery.
The team also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to see what happens to VCN-01 in the brain tumour. And to understand more about this virus treatment.
Hospital visits
You see the doctor and have tests before you can take part. These include:
- blood tests
- a
physical examination - urine test
- heart trace (
ECG ) - a test of your nervous system (neurological examination)
You stay overnight at the hospital after you have VCN-01. You then see the team for a check up and blood tests:
- the day after having VCN-01
- 2 days after having VCN-01
- the day before or on the day of surgery
- 1 month and 3 months after having VCN-01
Side effects
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
VCN-1 is a new treatment so we don’t know what all the side effects are. The most common side effects we know about so far include:
- flu-like symptoms
- high temperature (fever)
- chills
- tiredness (fatigue)
- headache
- body aches, muscle or joint pain
- cough
- feeling or being sick
- loss of appetite
- diarrhoea
VCN-01 is a virus that can infect humans. You need to take precautions to avoid spreading it to other people for up to 7 days after the VCN-01 injection. These include measures you would use to prevent passing on a cold or flu virus such as:
- washing your hands with soap after using the bathroom
- avoiding sharing drinks and cutlery
- using detergent to wash your dishes, either by hand or in a dishwasher
- avoiding close contact with pregnant women and babies
- avoiding close contact with people with weakened immune systems
- cleaning your toilet with bleach after each use
The study doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask them any questions you may have.
Location
Recruitment start:
Recruitment end:
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.
Chief Investigator
Professor Adel Samson
Supported by
Cancer Research UK
University of Leeds
VCN Biosciences
Other information
This is Cancer Research UK trial number CRUKD/17/010.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
