
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at how well a combination of laser light treatment and a chemotherapy drug called bleomycin works to treat people with head and neck cancer.
If you have a cancer of the head and neck that developed from cells called , you usually have treatment with surgery, radiotherapy or chemotherapy, or a combination of these. If the cancer comes back after this, it can sometimes be more difficult to treat.
In this study, researchers are looking at a new cancer treatment called PC A11 for people in this situation. With this treatment you have 2 drugs. The first is called Amphinex, which makes body tissue sensitive to light. The second is bleomycin chemotherapy. After you have had Amphinex and bleomycin, the doctor directs a laser light either onto the surface of the cancer, or through fibres that are put directly into the cancer. The light activates the Amphinex, which in turn helps the bleomycin to get into the cancer cells and kill them.
You usually need several treatments of bleomycin. But researchers hope that when you have it in this way, you will only need one dose.
The aim of this study is to see if this treatment works and if it will be a safe choice for people with head and neck cancer that has come back after previous treatment.
You may be able to enter this study if
You cannot enter this study if
This phase 2 study is in 2 parts. Everyone will have PC A11. In part 1, the researchers need to find the best dose of light to use when they put the light fibres directly into the cancer. Doctors call this interstitial laser light treatment. They already know the best dose to use when shining the light onto the cancer.
Part 1 will recruit up to 18 people across Europe.
On the first day of treatment, you have Amphinex as an injection into a vein. This will take a few minutes. Four days later you have bleomycin through a drip into a vein. This takes about 15 minutes. A few hours later, you have the laser light treatment. You have this under a .
Once you are asleep under anaesthetic, the study team will place thin fibres into your cancer and shine the laser through them. The first people taking part have the lowest dose of laser light. If they don’t have any problems, the next few people have a higher light dose. And so on, until they find the best light dose to give. This is called a dose escalation study.
You stay in hospital for about 7 days, starting the day you have Amphinex. You will have regular tests during this time, including blood tests and monitoring of your heart rate, blood pressure and temperature. The team will regularly ask if you have any pain. They will also ask you to fill out some questionnaires asking about any other side effects and how you have been feeling. These questionnaires are called quality of life studies.
Part 2 of the study will recruit up to 68 people across Europe. How you have the light treatment and the dose you have will depend on where your cancer is. If you need to have light fibres put into your cancer to treat it, you will have the best dose of laser light found in part 1. If you need to have the laser light directed onto your skin above the cancer, you will have a dose that has already been chosen from a separate study.
You stay in hospital and have the same tests and procedures as the people in part 1.
Everybody taking part has regular blood tests throughout the study. The team will tell you more about the tests you need to have. They will also ask if you would be happy to give another sample of your cancer around 3 months after your PCA 11 treatment, and again if your cancer gets worse. And they will ask you to give some extra blood samples. They would like to test these samples to learn more about the study treatment in relation to special characteristics of the cancer cells. You do not have to agree to this if you don’t want to. You can still take part in the rest of the study.
Amphinex is a substance that is activated by light. So, your skin and eyes will become sensitive to light for a time after you have it. You may wake up with special bandages to protect where you had the injection. Normal light can also activate Amphinex, so you will need to stay in a room with only low lighting for the first few days. You can slowly increase the amount of light as the days go by. The team will give you instructions on how to protect yourself until things return to normal, which may take up to 3 months.
Before you start the study, you see the doctor and have some tests. These tests and examinations include
The study team will also take a sample of your cancer (a biopsy).
Whichever part of the study you join, you will be in hospital for about 7 days. This is so the team can monitor you after each part of the treatment.
Following treatment, people in part 1 see the doctor, have a blood test and fill out questionnaires about any pain and their quality of life after 4 weeks, 8 weeks and 3 months. You also have a CT scan or MRI scan after 3 months.
You may continue to have these visits and scans about every 3 months for a year.
People in part 2 will have 8 hospital visits in the year following treatment.
You have a CT scan or MRI scan at many of these visits so the team can see how you are getting on.
Although doctors routinely use drugs similar to Amphinex, only a small number of people have had Amphinex alongside bleomycin. So there may be side effects the researchers don’t know about yet.
The most common side effect of a drug like Amphinex is that you become sensitive to the light. You may have skin reactions such as sunburn, darkening of your skin, burns, blistering and redness. The team will give you instructions on how to protect yourself to try to prevent this.
Side effects of the light treatment itself may include
Bleomycin can sometimes cause lung problems. If you have any shortness of breath, difficulty breathing, wheezing, fever or chills you should contact your study doctor straight away. Other side effects of bleomycin include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Martin Forster
NIHR Clinical Research Network: Cancer
PCI Biotech
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”