Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of vorinostat for advanced mesothelioma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called vorinostat (also known as MK0683) for mesothelioma of the lung that has continued to grow despite having chemotherapy.
Doctors can treat mesothelioma with chemotherapy. But this type of cancer often comes back and researchers are looking for new treatments to help people in this situation. In this trial they are looking at a drug called vorinostat.
In cancer cells, there are chemical messengers (
Everybody taking part in the trial will have all treatment that is available to help any cancer symptoms and to improve their quality of life. Researchers usually call this best
The aims of the trial are to
- See if vorinostat and best supportive care is better than best supportive care alone for advanced mesothelioma
- Learn more about the side effects
Who can enter
You can enter this trial if you
- Have mesothelioma of the lung that has got worse despite having at least 1 type of chemotherapy
- Are well enough to take part
- Have satisfactory blood test results
- Are at least 18 years old
You cannot enter this trial if you
- Have already had any other drugs that work in a similar way to vorinostat (the trial doctors can advise you about this)
- Have any other cancer apart from mesothelioma
- Are HIV, hepatitis B or hepatitis C positive
- Are pregnant, breastfeeding or planning to become pregnant
This is an international phase 3 trial that will recruit about 660 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
Half the people taking part will have vorinostat capsules to swallow twice a day. The other half will take capsules that contain a dummy drug (
Each week, you take the capsules on 3 days, followed by 4 days without treatment. The researchers call every 3 weeks of treatment a treatment cycle.
As long as it is not causing bad side effects, you can carry on having the trial treatment for as long as it helps you. Depending on the results of tests and scans during treatment, the trial doctors may reduce the dose you take, or change the number of days on which you take the capsules.
The researchers will ask you to fill out a questionnaire before you start treatment, at the beginning of the 2nd, 3rd, 4th and 8th treatment cycles, and when you finish treatment. The questionnaire will ask about any side effects you have had and how you have been feeling. This is called a quality of life study.
You will see the trial doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan
- Heart trace (
- Tests to measure your breathing (
lung function tests)
You go to see the trial doctors twice in the 1st cycle of treatment and once in each cycle you have after that.
You have a CT scan every 7 weeks during the 1st year of treatment. If you carry on having treatment for longer than a year, you will then have a scan every 3 months.
You go back to see the trial doctors about a month after you finish treatment. And you may need to have another scan. They will then continue to monitor your progress every 2 months until the trial is completely finished. This may be at hospital appointments, or a nurse will contact you by phone to see how you are and whether you have started any other treatment.
If you stop having treatment in the first 12 weeks, the researchers will ask you fill out a quality of life questionnaire every 3 weeks up to week 12.
Vorinostat is still quite a new drug and there may be side effects we don’t know about yet. The most common known side effects include
- Tiredness (fatigue)
- Diarrhoea or constipation
- Poor appetite and taste changes
- Feeling or being sick
- Dry mouth
- Shortness of breath or difficulty breathing
- High levels of sugar in your blood
- Changes to the way your kidneys work
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Weight loss
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.
Dr Paul Robinson
Experimental Cancer Medicine Centre (ECMC)
Sharp & Dohme