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:

Brain (and spinal cord) tumours

Cancer spread to the brain

Secondary cancers

Status:

Closed

Phase:

Phase 1

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.