A trial of dabrafenib and trametinib for children and young people with a glioma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
- slow growing (low grade)
- fast growing (high grade) and continued to get worse during treatment or came back after treatment
More about this trial
- dabrafenib and trametinib or
- carboplatin and vincristine (standard treatment)
- how well dabrafenib and trametinib works for children and young people with a glioma
- how dabrafenib and trametinib works in the body of children and young people
- out about the side effects of having dabrafenib and trametinib together
- out how tasty and acceptable liquid dabrafenib and liquid trametinib is
Who can enter
- have a low grade glioma that has got worse following surgery or can’t be removed by surgery and needs treatment or you have a high grade glioma that got worse during treatment or came back after treatment
- have a glioma with a change (mutation) in the BRAF V600 gene
- have a glioma that can be measured on a scan
- might need quite a lot of help to look after yourself (Karnofsky performance status 50 or more) or you can get dressed, lie down for most of the day and take part in quiet play (Lansky performance status 50 or more)
- have satisfactory blood test results
- are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant
- are at least 12 months old and haven’t yet had your 18th birthday
- have another cancer
- have already had dabrafenib, trametinib or any other drug that works in a similar way
- have had another cancer treatment within 3 weeks of starting treatment, if you are taking steroids you must be taking a stable dose or a reducing dose a week before starting treatment
- have had radiotherapy to the glioma within 3 months unless a scan shows that the glioma has continued to grow
- have had an experimental drug as part of a clinical trial within 3 weeks of starting treatment
- have had another cancer that had a gene change (mutation) in the RAS gene or a combination of genes that included the BRAF gene
- have ongoing moderate to severe side effects from any previous cancer treatment
- have had a stem cell transplant within 3 months of starting treatment
- have had graft versus host disease (GVHD)
- are taking medication including herbal treatments that affect the CYP enzymes
- have had a heart attack, unstable angina or heart surgery in the past 6 months
- have any other serious heart problem such as congestive heart failure
- have a problem with your digestive system that could affect how well you absorb tablets, capsules or liquid medication
- have hepatitis B or hepatitis C
- have any other medical or mental health condition that your doctor or the trial team think could affect you taking part
- are sensitive or allergic to dabrafenib, trametinib or any of their ingredients
- are pregnant or breastfeeding
Trial design
- a fast growing (high grade) glioma
- a slow growing (low grade) glioma
- dabrafenib and trametinib
- carboplatin and vincristine
- once a week for 10 weeks
- followed by no treatment for 2 weeks
- followed by maintenance treatment
- once a week for 4 weeks
- followed by no treatment for 2 weeks
- every month for 3 months
- then every 8 weeks for about 9 months
- then every 16 weeks while you are having treatment
- why the treatment has stopped working
- more about how dabrafenib and trametinib works
- why dabrafenib and trametinib works better for some people and not others
Hospital visits
- a physical examination
- blood tests
- heart trace (ECG)
- CT scan
- MRI scan or x-ray of your shin bone or wrist
- heart scan (ECHO)
- eye examination
- every week for 5 weeks
- at 2 months
- then every 2 months for about 9 months
- then every 3 to 4 months until you start a new treatment for your glioma
- every 2 months for about 9 months
- then every 16 weeks until your glioma starts to grow or you are no longer in the trial
- 16 weeks
- 48 weeks
- then every year until the end of treatment
Side effects
- you have severe side effects
- your side effects aren’t getting any better
- your side effects are getting worse
- high temperature sometimes with low blood pressure, low amount of fluid in the body (dehydration), dizziness and, or fainting
- inflammation of the nose and throat
- bleeding
- a change to the way the liver works
- loss of appetite
- dizziness
- headache
- cough
- tummy (abdominal) pain
- diarrhoea or constipation
- feeling or being sick
- weakness
- dry and, or itchy skin
- pain and stiffness of joints
- muscle pain
- tiredness
- pain in the arms or legs
- swelling of the arms and, or legs
- high blood pressure
- chills
- flu like illness
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Darren Hargrave
Supported by
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040