A trial looking at adenovirus-delivered interferon alfa 2b with celecoxib and gemcitabine or celecoxib and gemcitabine for mesothelioma (INFINITE)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Mesothelioma

Status:

Closed

Phase:

Phase 3

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.

More about this trial

Adenovirus-delivered interferon alfa 2b (rAd-IFN) is a drug. It is an immunotherapy Open a glossary item drug used to treat some cancers. It works by stimulating T cells and other immune system 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 gene Open a glossary item 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 (NSAID Open a glossary item ).

Researchers think the combination of rAd-IFN and celecoxib might help people with mesothelioma of the lung.

In this trial you have either:

rAd-IFN with celecoxib followed by gemcitabine or
celecoxib followed by gemcitabine

The aims of the trial are to find:

out if having rAd-IFN with celecoxib followed by gemcitabine is better than having celecoxib on its own followed by gemcitabine
how safe it is to have rAd-IFN
how rAd-IFN affects quality of life

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 (pleural mesothelioma) that is epithelioid or biphasic cell type
have had at least 1 treatment and no more than 2 treatments for your mesothelioma, 1 of which must be the combination of an anti-folate drug and a platinum drug such as cisplatin or carboplatin
have an area of mesothelioma that can be seen and measured on a CT scan
can have a tube put into the space between the sheets of tissue that cover each lung (a pleural catheter)
are as active as you were before you had cancer, but might not be able to do heavy physical work (performance status 0 or 1)
have satisfactory blood test results
are willing to use contraception during and for 1 month after treatment for women and 6 months after for men if you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this trial if any of the below apply.

Cancer related
You:

have not had treatment with a combination of an anti-folate drug and a platinum drug
have had more than 3 treatments for mesothelioma
have mesothelioma that has spread from your chest to another part of the body (metastatic)
have had gemcitabine
have a CT scan that shows there is fluid around the heart (pericardial effusion)
have had chemotherapy in the past 3 weeks
have had a targeted drug in the past 2 weeks
have had a monoclonal antibody in the past month
have had an immunotherapy that isn’t an antibody such as a cancer vaccine in the past 6 weeks
have had radiotherapy in the past 2 weeks
have had blood cell growth factors in the past 2 weeks
have had an experimental drug in the past month
have another cancer and the treatment finished less than 2 years ago or you still have signs of the cancer. You might be able to join if you have another cancer as long as it is stable and does not need any treatment.

Medical conditions
You cannot join this trial if any of these apply. You:

have had interferon for another medical condition such as hepatitis
have a major problem with your breathing and how your lungs work
have heart problems such as congestive heart failure, a heart attack in the past year or problems with how well your heart pumps blood
have had an infection or chest pain (angina) that has not been controlled in the past year
have depression or another mental health problem that has not been controlled in the past year
have or might have an autoimmune disease apart from lightening of the skin (vitiligo), an underactive thyroid needing only hormone replacement, psoriasis not needing treatment that reaches the whole body or any condition not expected to happen again
are taking medication that damps down the immune system apart from steroids equal to or less than 10mg a day
have an allergic type reaction such as asthma, inflammation of the tissue lining the nose (rhinitis), hives or swelling of the lips, mouth or throat after taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) including COX 2 inhibitors such as rofecoxib, valdecoxib and ibuprofen
have had stomach ulcers or bleeding in your stomach or gut (intestines)
have high blood pressure that is not controlled or poorly controlled that needs you to take 3 or more different medications for it
have an abnormal heart trace (ECG ) that your doctor may be concerned about which shows a long QT interval
are taking lithium
have HIV or a similar disease that affects how well your immune system works
are not able to have a sugar found in milk called galactose or you are not able to digest and absorb other sugars such as lactose and glucose
have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part

Other
You cannot join this trial if you are pregnant or breastfeeding.

Trial design

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:

adenovirus-delivered interferon alfa 2b (rAd-IFN) with celecoxib followed by gemcitabine
celecoxib on its own followed by gemcitabine

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You have rAd-IFN into the space between the sheets of tissue surrounding the lung (the pleural space).

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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:

urine
spit (saliva)
break in the skin such as a wound

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:

2 to 3 hours
24 hours
7 days
14 days
21 days
28 days

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:

your general health
your ability to do daily activities
side effects of treatment

Hospital visits

You see the doctor for tests before taking part. These include:

physical examination
blood tests
urine test
heart trace (ECG )
CT scan

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:

a physical examination
blood tests
heart trace

After this, the trial team follow you up either at the clinic or by phone every 3 months.

Side effects

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:

feeling anxious (anxiety)
tiredness (fatigue)
feeling or being sick
diarrhoea or constipation
shortness of breath
high temperature (fever)
general feeling of discomfort
headache
muscle and or joint pain
difficulty sleeping
skin rash
low levels of oxygen
fast heart beat
low blood pressure
chest pain
a condition where pus and fluid from infected tissue collects inside a body cavity for example in the chest
mini stroke (TIA)
inflammation of the lining around the heart
a drop in blood cells causing tiredness, shortness of breath, an increased risk of infection, bruising and bleeding
high levels of transaminase in the blood
high levels of nitrogen containing compounds in the blood
high or low levels of bilirubin in the blood
changes to how your kidneys work showing as high levels of creatinine in the blood