A study looking at the effects of a drug called Reolysin in people with cancer affecting the brain (REO 13 BRAIN)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at a drug called Reolysin in people with cancer that started in, or has spread to, the brain.
More about this trial
Reolysin is a cancer treatment made from a type of virus called reovirus. Reovirus is common and causes only minor symptoms such as cough, colds and diarrhoea. We know from research that Reolysin can kill cancer cells. But we do not yet know if it can reach, or affect, cancer cells in the brain.
Researchers in this study will recruit people who have a primary brain tumour that has come back or who have cancer that has spread to the brain, and are waiting for surgery to remove these tumours. Everyone taking part will have Reolysin before their surgery. The team will then look at brain tumour tissue removed during your surgery to see if the reovirus affected the cancer cells. They will also monitor how your immune system responds to the virus.
The aim of this study is to find out more about the effect of reovirus on brain tumours that have come back after treatment, or on cancer that has spread to the brain from another part of the body. You will not have any direct benefit from taking part in this study, but the results will be used to help people with cancer in the future.
Who can enter
You may be able to enter this study if
- You have cancer that started in your brain and has come back after treatment, or has spread to your brain from another part of the body
- Your brain tumour is relatively fast growing (it is high grade)
- Your tumour can be measured on a scan
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception throughout the study and for 60 days afterwards if there is a risk that either you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this study if you
- Have had any radiotherapy, chemotherapy or surgery in the last 28 days - if you had a sample of tissue removed for diagnosis (a biopsy), you may still be able to take part
- Are still having side effects from any radiotherapy, chemotherapy or surgery
- Will be taking part in another clinical drug trial while you are on this study
- Are taking any medication that damps down your immune system, except steroids
- Have a serious heart problem
- Have hepatitis B, hepatitis C or HIV
- Have any mental problem, meaning that you were not able to understand fully about this study
- Are pregnant or breastfeeding
- Have any other condition that would make you unwell if you took part, or affect the results of the study – you can ask your doctor about this
Trial design
This study will recruit 24 people into 3 groups. The group you join will depend on when you enter the study. Everyone taking part will have Reolysin before their planned brain surgery.
- If you are in group 1, you have Reolysin on day 1 of the study
- If you are in group 2, you have Reolysin on days 1 to 3
- If you are in group 3, you have Reolysin on days 1 to 5
You have Reolysin through a drip into a vein. The study team will monitor your blood pressure, pulse and temperature before, during and up to an hour after you have the drug.
You fill out a diary card to record any side effects you may have such as cough, runny nose, diarrhoea or tummy pain. You will also give blood samples on the days you have Reolysin (if you are in group 1, you also give a blood sample on day 3 of the study), and before and after your surgery.
During the days you have Reolysin, and for 2 days afterwards, the team ask that you take the same precautions to protect others that you would if you had a cold or flu. This includes avoiding direct contact with people who have a severely compromised immune system. The team will give you some guidelines to follow for this.
Hospital visits
Before you start the study, you will see the doctor and have some tests. These tests include
- Physical examination
- Urine and blood tests, including blood tests for HIV and hepatitis
- Heart trace (
ECG 
) - CT scan or MRI scan
You visit the hospital each day you have Reolysin. If you are in group 1, you make an extra visit on day 3 to see the team and give another blood sample. So, depending on the group you are in, you could be making between 2 and 5 extra visits over the week.
Before your surgery and one month after surgery you have a physical examination and some blood tests. The team will pay for travel and car parking costs for visits directly related to this study.
Side effects
Side effects of Reolysin include
- Raised temperature
- Cough
- Runny nose
- Feeling sick
- Diarrhoea
- Tummy pain
- Headache
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 Alan Melcher
Professor Susan Short
Supported by
Brain Tumour Research and Support across Yorkshire (BTRS)
Experimental Cancer Medicine Centre (ECMC)
Oncolytics Biotech Inc.
University of Leeds
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
