A study looking at VCN-01 to treat brain tumours

Cancer type:

Brain (and spinal cord) tumours
Secondary cancers




Phase 1

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) Open a glossary item 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 Open a glossary item 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 Open a glossary item 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 Open a glossary item
  • 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 Open a glossary item
  • have tested positive for COVID-19 
  • are in close contact with people whose immune systems Open a glossary item 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 Open a glossary item to join the study
  • have any other medical condition or mental health problem that could affect you taking part in the study

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 (biopsy Open a glossary item) 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 Open a glossary item 
  • urine test
  • heart trace (ECG Open a glossary item)
  • 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: 

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.



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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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