Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A study of ADI-PEG 20 with pemetrexed and cisplatin for advanced cancer (TRAP Study)
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
Our bodies can make arginine using a protein (an
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
- Non small cell lung cancer (NSCLC) has spread to
lymph nodeson the other side of your chest, into nearby body structures, or to another part of your body (stage 3B or 4)
- Mesothelioma in your chest (pleural mesothelioma) that has spread to another part of your body
- Melanoma of the eye that has spread to another part of the body
- A type of brain tumour called high grade glioma
And all of the following must apply.
- Your cancer cells don’t have the
enzymethat 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
radiotherapyor 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
chemotherapyfor 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 marrowin 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
- Have an infection that needs
antibioticsthrough a drip into a veinwithin 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(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
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
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.
You see the doctor to have some tests before taking part in this study. These tests include
- A physical examination
- Blood tests
- CT scan or MRI scan
- Chest X-ray
- Heart trace (
- PET-CT scan (2nd part only)
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.
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)
The most common side effects of pemetrexed and cisplatin can include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Sore mouth
- Numbness or tingling in your hands or feet
- A change to the way your kidneys work
- Inflammation of your eyelids
- Ringing in your ears
- Taste changes
We have more information about pemetrexed and cisplatin.
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.
Experimental Cancer Medicine Centre (ECMC)