
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people with mesothelioma of the lung (pleural mesothelioma) who have had previous treatment. Malignant pleural mesothelioma is a tumour of the lining of your lungs.
Adenovirus-delivered interferon alfa 2b (rAd-IFN) is a drug. It is an drug used to treat some cancers. It works by stimulating
and other
cells to attack the cancer cells.
rAd-IFN is a combination of an adenovirus and interferon alfa 2b. It is a changed adenovirus.
Adenoviruses are common viruses that cause colds and infections of the throat and airways. The adenovirus in this trial is changed so it can’t make copies of itself and is unlikely to cause an infection.
The adenovirus carries the gene for making interferon alfa 2b into the cells. Inside the cells this can then instruct the cells to make interferon alfa 2b.
When the gene gets into the mesothelioma cells it starts to make interferon alfa 2b. It does this for about 2 to 4 weeks and then the mesothelioma cells get rid of the gene.
Research in the laboratory shows that rAd-IFN might help people with mesothelioma.
Gemcitabine is a chemotherapy drug doctors use to treat mesothelioma of the lung.
Celecoxib is a nonsteroidal anti inflammatory drug ().
Researchers think the combination of rAd-IFN and celecoxib might help people with mesothelioma of the lung.
In this trial you have either:
The aims of the trial are to find:
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:
Who can’t take part
You cannot join this trial if any of the below apply.
Cancer related
You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if you are pregnant or breastfeeding.
This is an international phase 3 trial. 300 people worldwide are required to join this trial.
It is a randomised trial. There are 2 groups. Neither you nor your doctor choses which group you are in. You have an equal chance of being in either group. The 2 groups are:
You have rAd-IFN into the space between the sheets of tissue surrounding the lung (the pleural space).
You have a line (pleural catheter) that goes into the pleural space. If you don’t already have one, you have it put in before starting treatment.
You have 1 treatment with rAd-IFN in the hospital. The doctor puts it down the line into the pleural space. You stay in hospital for 6 hours afterwards so the health team can monitor you. You might need to stay overnight in hospital. Your doctor will talk to you about this if this is the case.
Celecoxib is a capsule or a tablet. You start taking it when you have rAd-IFN. You take celecoxib for 2 weeks. You take it twice a day. You have a diary to write down when you took celecoxib and how many.
You have gemcitabine as a drip into a vein. You start gemcitabine on the same day as your last dose of celecoxib.
You have gemcitabine treatment in cycles. Each cycle is 3 weeks. You have it once a week at the start of week 1 and week 2. You then have a week of no gemcitabine. You continue having gemcitabine as long as it is working and the side effects are not too bad.
Viral shedding
Viral shedding is where small bits of viruses come out in body fluids, for example:
As rAd-IFN is a changed virus, the team want to find out if this happens after having rAd-IFN.
To do this they will ask 30 people having rAd-IFN to collect their urine and spit. They will also collect a sample from the space between the sheets of tissue that cover each lung and wipe (swab) around where the pleural catheter enters the skin.
You do this after you have rAd-IFN at:
You don’t have to agree to this if you don’t want to. You can still take part in the trial.
Blood samples
You give blood samples several times during the trial. Your doctor or a member of the trial team will talk to you about this.
Quality of life
You fill in a quality of life questionnaire at the start of each cycle of gemcitabine. The questions ask about:
You see the doctor for tests before taking part. These include:
You see the doctor during treatment at regular times to see how you are.
You have another CT scan every 9 weeks.
At the end of treatment you see the doctor for:
After this, the trial team follow you up either at the clinic or by phone every 3 months.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
rAd-IFN can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.
If you have any of these side effects, you should tell the doctor or nurse as soon as possible. Tell them that you are having, or have had an immunotherapy.
The common side effects of rAd-IFN are:
When you have rAd-INF you might also get an infection or pain where the pleural catheter goes in.
The common side effects of celecoxib are:
We have information about gemcitabine and its side effects.
Your doctor or a member of the trial team will talk to you about the side effects of all the treatments before you agree to join the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Nicola Steele
Trizell Ltd.
Medpace Inc.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.