Research

There are several phases to developing a new treatment:

• Pre-clinical research: Pre-clinical research involves testing a new treatment in the laboratory using animal or laboratory models of cancer. Pre-clinical research also aims to determine the safety and side effects of a new treatment, what dose it should be given at, and how frequently it should be given.
• Phase 1: The main objective of a phase 1 trial is to find out what is the right dose to use and what the side effects of the new treatment are. Initially, treatment is given given at a low dose to a group of patients. The patients are observed for a period of time and if no serious side effects occur then another group of patients is given the treatment at a higher dose. This process is repeated until the “maximum tolerated dose” is found.
• Phase 2: The main of a phase 2 trial is to see whether the new treatment is effective at treating the tumour. A Phase 2 trial will also test the safety and side effects of treatment in a larger number of patients than the Phase 1 trial.
• Phase 3: These trials compare the new treatment to the existing “standard” treatment. If a phase 3 trial shows the new treatment is better than the standard treatment, this will lead to the new treatment being “licensed” for use in the group of patients that it was tested in. This will make it available for routine use.

If you decide to enter a clinical trial, there are several different steps:

Consent: You will be given a detailed patient information sheet (PIS) to read about the study. You will be given time to read the leaflet and think about whether you wish to join the trial. You will be given an appointment to discuss the trial with one of the study doctors or team, and to ask any questions you have. If you decide you would like to join the trial, you will be asked to sign an informed consent form (ICF). If you decide you wish to leave a clinical trial, you can do this at any point, and for any reason.

Screening: After you sign consent, the study team will do a number of tests to see if you meet all of the criteria to join the trial. This may include testing your stored tumour tissue to see if it has a mutation that is required to join a trial.

Randomisation: In many trials patients can receive several different treatments. Randomisation is the point at which it is decided which treatment you will receive. You will be randomly assigned to one of the treatments, usually by a computer. The study team do not have any control over which treatment you will receive.

There are potential advantages and disadvantages to entering a clinical trial.

Advantages:

• Access to a new treatment that is not available outside of a clinical trial, that may be effective in treating your tumour.
• You will be closely monitored and you may have more frequent scans to monitor your tumour.
• You will be contributing to important scientific research that may lead to better treatments for future patients with the same disease

Disadvantages:

• There is no guarantee that the experimental treatment will be better, or even as good as the current standard.
• There may be unexpected and potentially serious side effects with the new treatment.
• Entering a clinical trial is more time consuming than receiving treatment outside of a trial. You will have to visit the hospital more frequently and have more tests done.

UCLH has a variety of different trials open for patients with different types of brain tumours. Trials can sometimes only be open for a few months, and so as not to be out of date we have not listed them here. If you are interested in finding out which trials are available, please contact the Brain Tumour Service.

If you are not already under the care of UCLH and would like to discuss entering a clinical trial, please ask your GP or hospital doctor to send a referral to the Brain Tumour Service.

You can also click here to search our clinical trials database.

As well as research in patients, staff at UCLH are also carrying out extensive research in the laboratory. This research improves our understanding of brain tumours and can lead to better diagnostic tests and new treatments. The Brain Tumour Service at UCLH have close links to the UCL Glioma Research Group, UCL Cancer Institute, UCL Institute of Neurology and UCL Institute of Child Health.