A trial of a new drug called ADI-PEG 20 with chemotherapy for people with mesothelioma (ATOMIC-Meso)

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 looking at a new drug called ADI-PEG 20 with cisplatin and pemetrexed. It is for people with mesothelioma that started in the lining of the lungs (pleura) and that can’t be cured by surgery.

More about this trial

Mesothelioma can start in the lining of the lungs or the tummy (abdomen). Pleural mesothelioma is when it starts in the lining of the lungs.

Some people with pleural mesothelioma have surgery. But surgery is not possible for many people with mesothelioma because their cancer has grown too far. This is advanced cancer.

You usually have treatment with chemotherapy for advanced pleural mesothelioma. Cisplatin and pemetrexed is a standard treatment for pleural mesothelioma.

But doctors are looking at new ways to help people with advanced mesothelioma. In this trial, they are looking at a new drug called ADI-PEG 20.

Researchers have found a new way of destroying cancer cells, by removing a substance called arginine. Arginine helps with different jobs in the body, including cell growth. Doctors think that if you remove arginine, cancer cells will not be able to replace it. And this might stop the cancer cells from growing.

Doctors know from laboratory studies and other clinical trials, that ADI-PEG 20 can remove arginine from cells.

Everyone taking part in this study has 1 of the following:

ADI-PEG 20 with pemetrexed and cisplatin
dummy drug (placebo ) with pemetrexed and cisplatin

The main aim of this trial is to find out how well ADI-PEG 20 with pemetrexed and cisplatin works for people with advanced mesothelioma.

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 a non-epithelioid (sarcomatoid or biphasic) pleural mesothelioma that can’t be cured by surgery – your doctor can tell you more about this
are going to have cancer treatment that reaches your all body (systemic) for the first time
are willing to have a sample of tissue taken, if there isn’t a suitable sample available that can be used to test for an enzyme called ASS1
have at least 1 area of cancer that can be seen and measured on a scan
have satisfactory blood test results
are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
are at least 18 years old
are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility you or your partner could become pregnant

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related
You:

have had ADI-PEG 20
have a type of mesothelioma called epithelioid
have had radiotherapy in the last 2 weeks, unless it was to help with symptoms (palliative radiotherapy)
have side effects from previous cancer treatment
have cancer spread in your brain or spinal cord and this is causing you symptoms
have had another cancer apart from carcinoma in situ of the cervix, basal or squamous cell skin cancer or any other cancer that have been successfully treated

Medical conditions
You:

have had a major surgery in the last month and you still have side effects from it (unless it was an operation to put a plastic tube into a vein of your chest or arm)
have an infection that needs treatment, or you have had antibiotics through a drip into your bloodstream (intravenously) in the last week
have heart problems such as congestive heart failure, an irregular heartbeat (arrhythmia), or you have had a heart attack in the past
have HIV
have fits (seizures)
are taking part, or are going to take part, in another clinical trial
have any other condition or mental health problem that the trial team thinks could affect you taking part

Other
You:

are pregnant or breastfeeding
are sensitive to cisplatin, pemetrexed, G-CSF or any other similar drug

Trial design

This is an international phase 2/3 trial. The researchers hope that around 386 people worldwide will take part.

This trial is randomised. Everyone is put into 1 of the following groups by computer:

ADI-PEG 20 with pemetrexed and cisplatin
dummy drug with pemetrexed and cisplatin

Neither you nor your doctor are able to decide which group you are in.

study diagram

You have ADI-PEG 20 or the dummy drug as an injection into the muscle of your shoulder, buttock or thigh. You have an injection every week.

Everyone has cisplatin and pemetrexed as a drip into a vein, every 3 weeks. It takes about 8 hours each time you have it.

To reduce the side effects of cisplatin and pemetrexed, you take folic acid tablets and vitamin B12 injections. Your doctor can tell you how often you need to have this.

You continue to have treatment for as long as it works and the side effects aren’t too bad. It can be for up to 18 weeks (4 and a half months).

You may be able to continue to have ADI-PEG 20 or the dummy drug after 18 weeks if it’s still helping you. Your doctor can tell you more about this.

Tissue sample
The researchers will ask to use a sample of your cancer taken when you were diagnosed. You need to have a biopsy Open a glossary item if there isn’t a suitable sample available.

Doctors want to test for an enzyme called ASS1. They might also use it in future studies to learn more about mesothelioma.

Doctors might also ask you to have a biopsy if your cancer gets worse. You don’t have to agree to this if you don’t want to. You can still take part in this trial.

Blood tests
You have some extra blood tests as part of this trial. Researchers are looking at the effect of ADI-PEG 20 in your body. They may also use the blood samples in future research studies.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

physical examination
blood tests
scans (your doctor can tell you which scans you need to have)
heart trace (ECG )

During treatment, you see trial team every week. You have a physical examination, blood tests and a heart trace at set times.

You have a CT scan or MRI scan every 6 weeks. This continues for as long as you are having treatment.

When you finish treatment, you see the trial team after a month. You then see or speak with the trial team every 3 months.

Side effects

The trial team monitor you while you are having treatment. They will give you a phone number to call them if you are worried about anything.

The team will tell you about the possible side effects before the start of treatment.

The common side effects of ADI-PEG 20 are: