A trial looking at stimulating the immune system to treat mesothelioma of the lung (TILT)

Cancer type:

Lung cancer
Mesothelioma

Status:

Open

Phase:

Phase 2/3

The researchers are comparing 2 ways to stimulate the immune system to treat mesothelioma of the lung. 

Some people who are taking part in the ASSESS-meso study will be invited to join this trial.

More about this trial

Mesothelioma of the lung is difficult to treat. Researchers are looking for other treatments to help people with this cancer. 
 
One type of treatment they are looking at is immunotherapy.
 
The immune system protects the body from infection and illnesses including cancer. It can identify and attack cancer cells in the body.
 
But people with mesothelioma have a reduced number of immune cells around the lining of their lungs. This means mesothelioma can hide from the immune system. 
 
Doctors have noticed that people with mesothelioma live longer if they have had an infection in the lining of their lung. They think this is because the cells of the immune system move into the lining of the lung and attack the mesothelioma cells as well as the infection. 
 
Researchers want to try and stimulate your immune system to kill the cancer cells. This is called immunotherapy.
 
In this trial the researchers are comparing 2 different types of bacteria to stimulate your immune system. 
 
OK-432 is a drug made from bacteria that has been treated with an antibiotic called penicillin and heat. It has been treated so that it cannot cause an infection. It is used in other countries to treat:
  • fluid build up around the lung caused by cancer
  • abnormal growths of the lymphatic system
Laboratory studies show that OK-432 can kill cancer cells in the fluid from around the lung caused by mesothelioma. 
 
BCG is live bacteria that has been treated so that it is less able to cause an infection. BCG is used as a vaccination for tuberculosis (TB) and to treat early stage bladder cancer. 
 
The researchers want to do a large clinical trial to compare these 2 bacteria. Before doing so they need to know if it is possible and practical. To find this out they will do a feasibility trial.
 
The main aims of this feasibility trial are to find out:
  • the possibility and practicality of doing a large clinical trial
  • if this type of trial is acceptable to people with mesothelioma of the lung and their relatives

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 mesothelioma of the lung
  • are taking part in the ASSESS-meso study and have consented to be considered for and randomly selected for future trials
  • have a permanent tube (indwelling pleural catheter) in your chest that has drained more 50mls of fluid on more than 3 occasions or you are suitable and willing to have a tube put in to your chest to drain the fluid
  • are up and about, can look after yourself but can’t work (performance status 0,1 or 2or you are in bed or a chair for more than half the day, need help to look after yourself (performance status 3) and your doctor thinks you are well enough to join the trial
  • are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply.
 
Cancer related
You:
  • don’t have a tube in to drain the fluid away from your chest or you can’t have one put in
  • have mesothelioma that has spread to the brain or spinal cord
  • have had chest surgery in the past 2 weeks or you have had a procedure affecting the lining of the lung unless it was to diagnose fluid on the lung or drain the fluid
  • have had chemotherapy in the 4 weeks before joining this trial
  • are planned to have chemotherapy in the 4 weeks after joining the trial
  • have a lung that can’t re-inflate so that at least half of it is in contact with the chest wall after the fluid has been removed 
  • have quite a lot or a very high amount of separations in the fluid, forming pockets trapping the fluid making it more difficult to drain 
  • have already had an immunotherapy treatment
Medical conditions
You:
  • have an immune system that isn’t working well
  • are taking medication that damps down your immune system
  • have an infection or signs that you might have a serious infection called sepsis
  • have active tuberculosis (TB)
  • have any other medical or mental health condition that the team think could affect you taking part in the trial
Other
You:
  • are already taking part in a clinical trial
  • are sensitive or allergic to penicillin, OK-432 or BCG
  • are pregnant or breastfeeding

Trial design

This is a phase 2/3 trial. The team need 12 people to join this trial.
 
You will be identified as being able to join this trial from the information you have given in the ASSESS-meso study. 
 
This is a randomised trial. You are put into 1 of 3 groups by a computer:
  • the first group has OK-432 treatment
  • the second group has BCG treatment
  • the third group has usual care, with no extra trial treatment

You go to a clinic at the trial hospital to have the treatment. You have 1 treatment with either OK-432 or BCG. The treatment is a liquid that is injected down the tube in your chest.
 
The doctor will drain your tube beforehand. You then have a chest x-ray. As long as the x-ray looks fine you have the treatment. The treatment liquid is left in your chest for an hour. Your tube is then drained again to remove the liquid.
 
After treatment you stay at the hospital for an hour. The team will observe you to make sure everything is okay. After the hour if everything is okay you can go home.
 
Interviews
At the end of the trial the team will invite you to an interview with a member of the team. At the interview you can talk about your experience of being in the trial. 
 
Samples
The team take a sample of fluid from around your lung when it is drained and measured. This happens:
  • when you agree to take part in the trial
  • before you have treatment
  • 3 weeks after treatment
  • 6 weeks after treatment
  • 12 weeks after treatment
Quality of life 
You fill in a quality of life questionnaire when you agree to take part. Then at:
  • 3 weeks
  • 6 weeks
  • 12 weeks

Hospital visits

You see the doctor to have some tests before taking part. These tests include:
  • a physical examination
  • blood tests
  • chest x-ray
  • ultrasound of your chest
  • CT scan of your chest
You will also be asked to score your symptoms on a scale of 1 to 100.
 
On the day of your treatment you have:
  • your blood pressure, pulse and temperature taken
  • blood tests
  • chest x-ray
  • ultrasound of your chest
After treatment you see the doctor at:
  • 3 weeks
  • 6 weeks
  • 12 weeks
At these visits you have:
  • a physical examination
  • blood tests
  • chest x-ray
  • ultrasound of your chest
  • CT scan of your chest (if one hasn’t been done in the previous month)
At these visits you will also be asked to score your symptoms on a scale of 1 to 100.

Side effects

Your doctor or nurse will monitor you closely for any side effects when you have the treatment and for a while after.
 
When at home, let your trial team know as soon as possible if:
  • you have severe side effects
  • your side effects aren’t getting any better
  • your side effects are getting worse
  • you notice anything unusual or anything that has changed
The most common side effects of OK-432 include:
  • a mild fever that lasts less than a day
  • pain in or around your chest
  • feeling generally unwell and tired
  • loss of appetite
The most common side effects of BCG include:
  • a mild fever that can last up to 3 days
  • pain in and around your chest
  • feeling generally unwell and tired
  • loss of appetite
Because BCG is live bacteria there is a very small chance it might cause an infection in your chest or all over your body. If this does happen, you will be treated with medication used to treat tuberculosis (TB).
 
Your doctor, or member of the trial team will talk to you about all the side effects of OK-432 and BCG before you agree to take part in the trial.

Location

Bristol
Oxford
Taunton

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 Nick Maskell

Supported by

National Institute for Health Research (NIHR)
North Bristol NHS Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15340

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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