"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of TroVax with pemetrexed and cisplatin for pleural mesothelioma (SKOPOS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a vaccine called TroVax alongside chemotherapy for mesothelioma in the lining of the lungs (the pleura).
Mesothelioma is a type of cancer that can develop in the tissues covering the lungs or lining the
In this trial, researchers want to see if they can improve the treatment of pleural mesothelioma by adding a vaccine called TroVax.
TroVax helps the immune system to recognise and attack cancer cells. Many mesothelioma cells carry a protein called 5T4. In this trial, researchers want to find out if TroVax helps the immune system to recognise 5T4 and attack the mesothelioma cells that carry this protein.
The aim of the trial is to see if TroVax and chemotherapy helps people with pleural mesothelioma more than chemotherapy alone.
Who can enter
You may be able to enter this trial if you
- Have pleural mesothelioma that has grown into surrounding tissue or has spread to another part of your body
- Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Finished any other treatment for your mesothelioma (such as surgery or radiotherapy) at least 4 weeks ago
- Are willing to use 2 forms of contraception during the trial and for a month after your last dose of TroVax (3 months for women), if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain
- Have had a serious infection in the last 4 weeks
- Have already had treatment with TroVax or chemotherapy for mesothelioma
- Have had drugs that contain radioactive material (such as strontium) in the last 8 weeks
- Have had an experimental drug as part of another trial in the last month
- Have had any other cancer in the last 3 years, apart from carcinoma in situ of the cervix or non melanoma skin cancer
- Have an
- Have certain heart problems or any other medical condition that could affect you taking part
- Are taking steroids on a long term basis
- Have had an allergic reaction to another vaccination in the past
- Are allergic to eggs
- Are known to be HIV, hepatitis B or hepatitis C positive
- Have had an organ transplant
- Are pregnant or breastfeeding
This phase 2 trial will recruit 29 people in the UK.
Everybody taking part has chemotherapy and TroVax. You have the chemotherapy drugs through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. You have 4 cycles of chemotherapy.
You have TroVax as an injection into the muscle at the top of your arm. You have 9 injections over 24 weeks (nearly 6 months) starting 3 weeks before you start having chemotherapy.
To help control the side effects of pemetrexed, you take a steroid tablet called dexamethasone for 5 days in each cycle of chemotherapy. You also have folic acid tablets every day for 13 weeks, and you have vitamin B12 injections twice during the trial.
If you need to have fluid drained from your lungs as part of your treatment (a
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan (if you haven’t had one in the last 4 weeks)
- Heart trace (
- Heart ultrasound (
The trial treatment lasts for 24 weeks (nearly 6 months). During this time, you go to hospital at least 13 times. You have regular blood tests and 2 more CT scans.
After you finish treatment, you see the trial team 4 more times during the next 6 months, and you have 2 more CT scans.
- Feeling or being sick
- Damage to your kidneys
- A drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Numbness or tingling in your hands or feet (peripheral neuropathy)
- Changes to your hearing
- Taste changes
- Loss of appetite
The possible side effects of TroVax include
- Pain, itching or swelling at the injection site (or in nearby
- High temperature (fever) or chills
- Flu like symptoms
How to join a clinical trial
Dr Jason Lester
June Hancock Mesothelioma Research Fund
NIHR Clinical Research Network: Cancer
Velindre Cancer Centre Stepping Stones Appeal
Velindre NHS Trust
Wales Cancer Trials Unit