A trial looking at temozolomide for children and young people with diffuse pontine gliomas (CNS 2007 04)

Who can enter

You can enter this trial if you

• Have a diffuse pontine glioma
• Are well enough to have this treatment
• Have satisfactory blood test results
• Are aged between 2 and 21 years (21 year olds included)

You cannot enter this trial if you

• Have already had chemotherapy or radiotherapy
• Have a lot of sickness or any other condition that makes it difficult to take tablets
• Have a glioma that is described as ‘exophytic’ (this is a medical term and your specialist will be able to tell you if this applies to you)
• Are having any other experimental drug as part of another clinical trial
• Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit 43 children and young people. Everybody taking part will have radiotherapy and temozolomide chemotherapy.

You will have radiotherapy daily (Monday to Friday) for 6 weeks. During the radiotherapy, you will have temozolomide tablets once a day, including at weekends. If your child is very young or not able to take tablets, the doctors will give you information about how to put the contents of the tablets safely into a drink for them.

After the radiotherapy, there is a break of 4 weeks when there is no treatment. Then you will have an MRI scan. If the scan shows that the tumour has stayed the same size or is getting smaller, you will start temozolomide again. You take the tablets once a day, every day for 3 weeks. Then there is a week without any treatment. This 4 week period is called a cycle of treatment.

If the temozolomide is continuing to help, you will have up to 12 cycles of treatment, which will take about a year. You will have an MRI scan after every 3 cycles to see how well the treatment is working.

You will also have antibiotic tablets called co-trimoxazole (Septrin). This is because chemotherapy increases the risk of infection and Septrin helps to protect against a type of pneumonia called pneumocystis carinii pneumonia (PCP).

The doctor will ask you to fill in some questionnaires

• Before the treatment
• About a month after the radiotherapy
• Every 3 months during the temozolomide treatment

The questionnaires will ask about any side effects and how you have been feeling. This is called a quality of life study.

The doctors may ask you to take part in another study related to this one. This is looking at a new type of scan that may give doctors more information than a normal MRI scan. The new scan is called a Magnetic Resonance Spectroscopy (MRS) scan. If you take part in this study, each scan will take about 15 minutes longer. If you don’t want to take part in this study, you don’t have to. You can still take part in the main part of the trial.

Hospital visits

Before starting treatment, you will see the doctors and have some tests. These include

• Physical examination
• Blood tests
• MRI scan
• Chest X-ray

You go to the hospital 5 days a week for 6 weeks to have radiotherapy. You have a physical examination and blood test each week.

A month later, you will go back to hospital for an MRI or MRS scan. You will then have temozolomide tablets at home for up to a year. During this time, there are regular blood tests and a scan every 3 months. When treatment finishes, you will carry on seeing the doctors every 8 weeks.

Side effects

The common side effects of temozolomide include

• A drop in the white blood cell count causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
• Sickness
• Hair loss

There is more information about the side effects of temozolomide and the side effects of having radiotherapy to the brain on CancerHelp UK.