A trial looking at the timing of photodynamic therapy (PDT) for brain tumours

This trial is looking at whether photodynamic therapy alongside surgery is helpful for newly diagnosed brain tumours.

Doctors usually treat brain tumours with surgery and radiotherapy when they are first diagnosed.

Photodynamic therapy (PDT) is a new treatment that is still being tested in clinical trials for a few different cancers, including brain tumours. So far, PDT trials for brain tumours have recruited patients whose cancer had come back after treatment. This trial is looking at the use of PDT alongside surgery and radiotherapy as part of your first lot of treatment.

The aim of this trial is to see if it is better overall to have PDT alongside surgery and radiotherapy to begin with, or to wait and have PDT if the cancer comes back.

Recruitment

Start 01/02/2001

End 31/12/2012

Phase

Phase 2

Who can enter

You can enter this trial if you

Have been recently diagnosed with glioblastoma, anaplastic astrocytoma or invasive pituitary adenoma OR
Have cancer that has spread to just one area of your brain (a single metastasis) from another area of your body
Are well enough to take part

You cannot enter this trial if you

Have a brain tumour that is not cancerous (is benign) and is non invasive

Trial design

This is a phase 2 trial. It will recruit about 300 patients into 2 groups. The people taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

If you are in group 1 you will have surgery, then photodynamic therapy (PDT) and then radiotherapy. Because you have PDT after surgery, you may have radiotherapy slightly later than you would if you were not taking part in this trial. But you may not. If you do have radiotherapy a bit later there is no evidence to suggest that this will do you any harm.

If you are in group 2, you will have surgery followed by radiotherapy to begin with. You will not have PDT at this stage. But if your cancer comes back (recurs) or starts to grow again (relapses) in the future, you will have PDT then.

When you have PDT you have a drug called Photofrin. This is a photosensitiser. In other words, it makes you more sensitive to light. Photofrin mainly goes into your brain tumour cells. Very little goes into normal brain cells.

About 48 hours after your Photofrin the doctors use a carefully placed light fibre and keyhole surgery to shine a laser directly onto your brain tumour cells. When they shine the laser onto the cancer cells that have taken in the Photofrin, the cells die.

If the scans show that the PDT has worked well, but your cancer starts to grow again in the future, you may be able to have PDT again.

Hospital visits

You will be in hospital for 5 to 10 days when you have your operation. And you will stay in overnight when you have PDT. You have radiotherapy as an out patient once a day, Monday to Friday, for 4 to 6 weeks.

After your treatment you will see the doctors once every 3 months. You will have a physical examination and a CT scan at each visit. If you are in group 2 and there are signs that your cancer has started to grow again, you will then have PDT.

Side effects

Photofrin makes you more sensitive to light for about a month or so. It is very important that you cover up in the sun or bright light during this time. If you don’t, you will burn. Ordinary sunscreen is not enough. You must wear sunglasses, trousers, tops with long sleeves, a wide brimmed hat, gloves and socks. The doctors and nurses at the hospital will tell you about this in more detail.

Other side effects of PDT are similar to the side effects of both surgery and radiotherapy. They include the possibility of brain swelling (oedema) or possibly bleeding, although this is rare with PDT.