"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at treating small kidney tumours with a light activated drug
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 treatment called vascular targeted photodynamic therapy works to treat kidney tumours.
More about this trial
The treatment they are looking at in this study is called vascular targeted
Researchers in this study will recruit people who are waiting for surgery to remove a kidney tumour that their doctor thinks is likely to be cancer. They will have the light activated drug treatment a couple of weeks before their planned surgery. The team will then study a sample of the tumour removed during surgery, to see how it responded to the treatment.
The aim of this study is to find out how well vascular targeted photodynamic therapy treats small kidney tumours that may be cancer.
Who can enter
You may be able to enter this study if
- You have growths on your kidney shown up by a CT scan or MRI scan, and your doctor thinks these could be a type of kidney cancer called renal cell cancer
- These growths measure less than 4 cm and can be removed with surgery
- You have at least one growth that doctors can easily see on a scan
- You have not got these growths anywhere else
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are fit enough to have a
general anaestheticand surgery
- Your heart is working well enough – a heart trace (
ECG) will show this
- You are 50 years old or over
You cannot enter this study if
- You have had chemotherapy or biological therapy for cancer, or any surgery, in the last 4 weeks
- You have had radiotherapy close to the affected kidney in the last year
- You have problems with the way your liver works
- You have any kidney problems that would stop you being able to have surgery to treat them
- It would be difficult to treat your kidney growths without damaging other important body structures nearby
- You are taking medication that damps down your immune system
- You are taking medication that may make you more sensitive to light – you can ask your doctor about this
- You are taking medication to thin your blood, and you would not be able to stop this for the 10 days before your surgery - please note, you must not stop taking medication without speaking to your doctor first
- You are due to have surgery or another procedure needing general anaesthetic while on this study
- You are taking part in another clinical trial (if you are involved in a type of study called an observational study, you may still be able to take part)
- You are a woman still able to have children
- You have any other condition that may make you unwell if you took part, or affect the results of the study – you can ask your doctor about this
This study will recruit 12 people. Everyone taking part will have vascular targeted photodynamic therapy (VTP) a couple of weeks before the surgery already planned for them.
You have the treatment under general anaesthetic. Once you are asleep, you have the light activated drug (WST 11) through a drip into a vein. The team will then pass tiny laser fibres through needles placed into your tumour. The doctor shines a laser light through these fibres to activate the drug. After treating the tumour, they will remove the needles and fibres. The procedure takes between 2 and 3 hours.
The first people taking part will have the lowest dose of WST 11, and the fewest laser fibres put in. The next people will have more WST 11 or fibres. And so on, until they find the best combination to give. This is called dose escalation.
From 6 hours before your treatment, you can’t eat and can only drink clear fluids. You can’t drink anything at all for 2 hours immediately before treatment.
When you get to the ward to recover from the procedure, your room will be dark. This is because the WST 11 drug makes your body very sensitive to light for a few days after you have it.
You have a blood test 6 hours after the procedure to see how your body responded to the treatment. The team will monitor you in hospital overnight. You have another blood test the next day, and if you feel well, you can go home. The trial team will tell you about precautions you will have to take.
After you have the kidney surgery already planned for you, the team will collect and study some of the tissue removed to see how it responded to the light activated drug treatment.
Before you start the study, you see the doctor and have some tests. These tests include
- Physical examination
- Heart trace (ECG)
- Blood tests
- Chest X-ray
- MRI scan
You stay in hospital on the night of your light activated drug treatment. If you haven’t had any problems, you can go home the next day. 12 days after your treatment you have
- An MRI scan
- Physical examination
- Blood tests
When you have your kidney surgery, you will be in hospital for between 3 and 7 days. You then see the surgeon and research team and have a blood test
- 6 weeks after surgery
- 6 months after surgery
- 12 months after surgery
You also have further MRI scans 6 and 12 months after your surgery.
These visits will generally take several hours. The research team can tell you more about how long each will take.
The main possible side effect of having this treatment is light damage to the skin and eyes in the first 6 hours after having the drug. It circulates round your whole body, so any part could be affected if it is exposed to a particular kind of light. You should be safe in normal light after 48 hours.
The team will give you strict rules to follow to protect you from damage caused by light after the procedure. This includes how to protect yourself from daylight, how to watch television safely and avoiding light from bright light bulbs.
You may feel some discomfort where the laser fibres were put in, but the team will be able to give you standard painkillers for this.
You may also bleed a little where the fibres went in. In most cases this will not cause a problem, and you will have a dressing over the area. But rarely, you may need a blood transfusion or an operation to treat this. The team will monitor you after the procedure to check for bleeding.
There is also a small risk that the small wound where the fibres went in could become infected.
How to join a clinical trial
Mr Mark Sullivan
University of Oxford