A study of ADI-PEG 20 with pemetrexed and cisplatin for advanced cancer (TRAP Study)

Cancer type:

Brain (and spinal cord) tumours
Eye cancer
Head and neck cancers
Lung cancer
Non small cell lung cancer




Phase 1

This study is looking at a drug called ADI-PEG 20 with pemetrexed and cisplatin to treat cancer that has spread to another part of the body or a fast growing (high grade) brain tumour.

There are 2 parts to this study. The 1st part is now closed.  

The 2nd part is for people who have

More about this trial

Doctors can use chemotherapy to treat these cancers. One combination they might use is pemetrexed and cisplatin. This works but researchers are always looking for ways to improve treatment.

Researchers have found a new way of destroying cancer cells in the laboratory, by removing an amino acid Open a glossary item called arginine. Arginine helps with many different jobs in the body, including cell growth Open a glossary item.

Our bodies can make arginine using a protein (an enzyme Open a glossary item) that is often missing in some cancer cells. So if you remove arginine, these cells will not be able to replace it. And this may stop the cancer cells growing.

In this study, researchers are looking at a drug called ADI-PEG 20, which removes arginine.

In the 1st part of the study, the researchers want to find the highest safe dose of ADI-PEG 20 to give with pemetrexed and cisplatin. In the 2nd part, they will use this dose to find out how well it works for people who have non small cell lung cancer, mesothelioma in the chest, melanoma fo the eye or high grade glioma. They also want to find out about the side effects of having ADI-PEG 20 with pemetrexed and cisplatin.

Who can enter

There are 2 parts in this study. The part you are able to join depends on your disease.

If you have mesothelioma in your abdomen (peritoneal mesothelioma) that has spread to another part of your body, you are only able to join part 1 of the study.

You are able to join either part of the study if you have

And all of the following must apply.

  • Your cancer cells don’t have the enzyme Open a glossary item that makes arginine , or if they do, it is only a very small amount (the researchers will test for this)
  • You have an area of cancer that can be measured on a scan
  • You have fully recovered from any previous surgery
  • You have satisfactory blood test results
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use 2 forms of reliable contraception during treatment and for 35 days afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this study if any of these apply. You

  • Have cancer spread to your brain or spinal cord. You may be able to join if have had radiotherapy Open a glossary item or surgery to treat the cancer spread, you don’t have symptoms and it hasn’t got any worse for at least 1 month after
  • Have already had chemotherapy Open a glossary item for your non small cell lung cancer
  • Have already had ADI-PEG 20
  • Have had major surgery in the last month or haven’t fully recovered from any previous surgery
  • Have had radiotherapy in the last 4 weeks apart from radiotherapy for symptom control (palliative radiotherapy)
  • Have had radiotherapy to more than a quarter (25%) of your bone marrow Open a glossary item in the past 2 months (your doctor can tell you this)
  • Are still having side effects from any earlier treatment
  • Have had another cancer unless it has been successfully treated
  • Have had a bone marrow transplant Open a glossary item
  • Have an infection that needs antibiotics Open a glossary item through a drip into a vein Open a glossary item within a week of starting the study treatment
  • Have certain heart problems (the study team can advise you about this)
  • Have HIV, hepatitis B or hepatitis C
  • Have had fits (seizures) that were not caused by your cancer
  • Are taking drugs to thin your blood such as warfarin (you may be able to join if you are having a low dose of heparin)
  • Are allergic to any of the drugs used in the study or anything they contain
  • Are not able to have a PET-CT scan or are allergic to the radioactive dye Open a glossary item (tracer) used for a PET-CT scan (2nd part only)
  • Have any other medical condition or mental health problem that the researchers think could affect you taking part in this study
  • Are pregnant or breastfeeding

Trial design

This is a phase 1 study. The study team need 47 people to join. Everyone taking part will have ADI-PEG 20 with pemetrexed and cisplatin. This study is in 2 parts.

In the 1st part, the researchers want to find the highest safe dose of ADI-PEG 20 to give with pemetrexed and cisplatin. To do this the first few people taking part will have a low dose of ADI-PEG 20. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

In the 2nd part, the researchers will use the best dose of ADI-PEG 20 found in part 1 to treat people who have

  • Non small cell lung cancer
  • Mesothelioma in the chest
  • Melanoma of the eye
  • High grade glioma

You have ADI-PEG 20 as an injection into the muscle of your shoulder, buttocks or thigh. You have your 1st dose 2 days before your 1st dose of pemetrexed and cisplatin. You then have ADI-PEG 20 every week. You can continue having ADI-PEG 20 for as long as it is helping you and the side effects aren’t too bad.

You have pemetrexed and cisplatin through a drip into a vein every 3 weeks. You can have between 4 and 6 treatments of pemetrexed and cisplatin.

The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item and some extra blood samples.

If your cancer gets worse while having treatment, the researchers will ask to take another sample of cancer tissue (a biopsy). You don’t have to agree to this if you don’t want to.

They will use these samples to find out how ADI-PEG 20 works and the effect it has on your body. They may also use these samples in future research to find out more about your type of cancer.

Hospital visits

You see the doctor to have some tests before taking part in this study. These tests include

For the first treatment you see the doctor every week while having ADI-PEG 20 and then at every treatment. You have a physical examination and a urine test every 3 weeks.

You have a CT scan MRI scan or bone scan every 6 weeks for the first 18 weeks and then every 8 weeks after that.

People in the 2nd part of the study will have another PET-CT scan on day 2, week 3 and after finishing pemetrexed and cisplatin.

When you finish having ADI-PEG 20, you see the study team and have

  • A physical examination
  • A heart trace
  • A CT scan, MRI scan or bone scan
  • Blood tests
  • A urine test

Your doctor will then talk to you about how often they want to see you.

Side effects

The most common side effects of ADI-PEG 20 include

  • A reaction at the injection site causing discomfort, tenderness, warmth, redness, itching or pain
  • Tiredness (fatigue)
  • Rash

The most common side effects of pemetrexed and cisplatin can include

We have more information about pemetrexed and cisplatin.



Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Peter Szlosarek

Supported by

Experimental Cancer Medicine Centre (ECMC)
Polaris Group

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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