A trial of Reolysin and GM-CSF for glioblastoma multiforme (ReoGlio)

Cancer type:

Brain (and spinal cord) tumours

Status:

Open

Phase:

Phase 1

This trial is looking at a treatment made from a virus called reovirus. It is for a type of brain tumour called glioblastoma multiforme. 

It is for people who have had surgery to remove their brain tumour, or have had a sample of tissue (biopsy) taken from their brain tumour. But they have not had any other treatment so far. 

Cancer Research UK supports this trial. 

More about this trial

Glioblastoma multiforme (GBM) is one of the most common types of brain tumour in adults. 

You usually have treatment for GBM with chemotherapy alongside radiotherapy. This type of treatment is called chemoradiotherapy. 

Temozolomide (Temodal) is a chemotherapy drug. For brain tumours, you usually have temozolomide alongside radiotherapy. You then continue with more temozolomide (adjuvant treatment Open a glossary item). This is the standard treatment.

Reolysin is a cancer treatment that uses a virus Open a glossary item called reovirus. This is a common virus that only causes minor problems such as:

  • cough
  • colds 
  • diarrhoea

Doctors think that Reolysin can kill cancer cells, but they want to find out for sure. 

Everyone taking part in this trial has Reolysin as well as the standard treatment. They also have a drug called GM-CSF Open a glossary item. This is a growth factor Open a glossary item. It works by stimulating the immune system to make more white blood cells. Doctors think that increasing the numbers of white blood cells can help to carry the Reolysin into the brain tumour.

The main aims of this trial are to:

  • find the safest dose of Reolysin to give with GM-CSF
  • learn more about the side effects of Reolysin with GM-CSF

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply:

  • you have grade 4 glioblastoma multiforme  
  • you have had surgery to remove the brain tumour, or you have had a sample of tissue (biopsy) taken in the past 6 weeks
  • doctors think you can have radiotherapy with temozolomide, followed by more temozolomide (standard treatment)  
  • 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 at least 18 years old
  • you are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility you or your partner could become pregnant

Who can’t take part
You cannot join this trial if any of these apply. 

Cancer related
You:

Medical conditions 
You:

  • are taking more than 8 mg of the steroid drug dexamethasone every day 
  • have had GM-CSF or G-CSF since you have been diagnosed with glioblastoma multiforme  
  • have taken drugs that damp down your immune system (immunosuppressants), unless it was a small dose of steroids 
  • have an infection that isn’t controlled 
  • have a problem with the rhythm of your heart (arrhythmias)
  • have heart problems such as hypertension that isn’t controlled, you have had a heart attack in the past year, or you have any other serious heart problem 
  • have HIV
  • have hepatitis B or hepatitis C 
  • have any other serious medical condition or mental health problem that the trial team thinks could affect you taking part 

Other
You:

  • are sensitive to any of the drugs used in this trial, or anything they contain  
  • are pregnant or breastfeeding  

Trial design

This is a phase 1 trial. Researchers need around 24 people to take part. 

This trial is in 2 parts. In part 1 researchers are looking for the safest dose of Reolysin that you can have with GM-CSF. 

The first few people joining part 1 have a low dose of Reolysin. If they don’t have any serious side effects, the next few people have a higher dose. And so on, until doctors find the best dose. 

Once doctors find the best dose, they start part 2. Everyone has the best dose of Reolysin found in part 1. 
 
Everyone taking part has all of the following:

  • radiotherapy with temozolomide, Reolysin and GM-CSF for 6 weeks
  • no treatment for 4 weeks
  • then temozolomide, Reolysin and GM-CSF for about 6 months (adjuvant treatment)

For the first 6 weeks, you have treatment as follows: 

  • radiotherapy every weekday, Monday to Friday
  • temozolomide capsules every day 

During the 1st and 4th week of radiotherapy, you also have Reolysin and GM-CSF. 

You have: 

  • GM-CSF as an injection just under the skin (subcutaneous) on Monday, Tuesday and Wednesday. 
  • Reolysin as a drip into a vein (intravenously) on Thursday and Friday. 

You then have no treatment for 4 weeks.   

Adjuvant treatment
You have treatment over 28 days. Each 28 day period is a cycle of treatment. The first day of each cycle of treatment is the day 1. 

During each cycle of treatment, you have:

  • temozolomide capsules from day 1 to day 5 
  • GM-CSF as an injection under the skin on day 1, 2 and 3 
  • Reolysin as a drip into your bloodstream on day 4 and 5 

You have no treatment from day 6 to day 28. You then start a new cycle of treatment. 

You continue to have treatment for as long as it is helping you and the side effects aren’t too bad. It can be up to 6 cycles of treatment (about 6 months).

Quality of life 
Everyone taking part completes a quality of life questionnaire before the start of treatment and at set times during the trial. 

The questionnaire asks about how you have been feeling and what side effects you have had. 

Blood tests 
You might have some extra blood tests before the start of treatment and at set times during the trial. This is only for people who are going to St. James’s Hospital in Leeds. 

Researchers want to find out how the treatment affects your immune system Open a glossary item. These blood tests are optional. You don’t need to have the extra blood tests if you don’t want to. You can still take part in the trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

  • an MRI scan 
  • heart trace (ECG Open a glossary item)
  • a physical examination
  • blood tests
  • urine tests
  • tests to check how well your brain and nervous system are working (neurological assessment) 

You go to hospital for treatment. You should not need to stay in hospital overnight. 

During treatment, you see the trial doctor regularly for blood tests and physical examinations. Your doctor can tell you how often you see them. 

You have an MRI scan every 12 weeks while you are having treatment. This continues for as long as your cancer stays the same and does not get worse. You stop treatment if your cancer gets worse. 

When you finish treatment, you see the trial team after a month. You then see them every 3 months to check how you are. You also have an MRI scan every 3 months. 

Side effects

The trial team monitor you while you are having treatment and between treatments. You have a phone number to call them if you are worried about anything. 

The trial team will tell you about all the possible side effects before you start the trial. 

The most common side effects of Reolysin are:

The most common side effects of GM-CSF are:

  • tiredness (fatigue)
  • pain in the bones and muscles
  • flu like symptoms 
  • swelling, redness and pain at the injection site
  • a high temperature for up to 4 hours after the injection
  • diarrhoea

We have more information about the side effects of temozolomide. And information about radiotherapy and chemotherapy for brain tumours.

Location

Glasgow
Leeds
Manchester

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 Susan Short

Supported by

Cancer Research UK 
The Brain Tumour Charity
Oncolytics Biotech Inc
Yorkshire Cancer Research
University of Leeds

Other information

This is Cancer Research UK trial number CRUKD/16/007

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14314

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

Rhys was only four years old when he was diagnosed with a brain tumour

A picture of Rhys

"He went through six operations and was placed on a clinical trial so he could try new treatments.”

Last reviewed:

Rate this page:

Currently rated: 5 out of 5 based on 1 vote
Thank you!
We've recently made some changes to the site, tell us what you think