A trial looking at sorafenib in skin schwannomas
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at how sorafenib (Nexavar) works in schwannomas of the skin.
Skin schwannomas are non cancerous (
) tumours that may develop on the skin of people who have a condition called type 2 (NF 2). NF 2 is a condition that is caused by changes in the in the body’s cells. People with NF 2 have an increased risk of developing certain types of tumours. Neurofibromatosis is difficult to treat and doctors are looking for new ways to manage it.
More about this trial
Sorafenib is a biological therapy called a tyrosine kinase inhibitor (TKI). TKIs block tyrosine kinase which is a chemical messenger (an enzyme) that sends messages to tell cells to divide and grow. Blocking the effect of tyrosine kinase may stop tumour cells growing.
The aim of this trial is to find out how much sorafenib gets into the skin schwannomas of people with NF 2. This may help doctors to decide whether or not to look at sorafenib in trials as a treatment for tumours caused by a change to the NF 2 gene.
Who can enter
You may be able to enter this trial if you
- Have been diagnosed with
neurofibromatosis type 2 - Have at least one skin schwannoma from which two small samples of skin (1cm long by 1cm deep) can be taken
- Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are able to swallow tablets
- Are willing to use 2 reliable methods of contraception during the study and for 3 months afterwards if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have heart failure or take medication to help regulate your heart rhythm (apart from beta blockers or digoxin)
- Have had a heart attack in the past 6 months, have high blood pressure that is not controlled by medicine, or another heart problem that is a cause for concern – the trial doctors can advise you about this
- Have problems with your
digestive system such as diarrhoea or ulcerative colitis, that could affect the way you absorb sorafenib - Have had inflammation of the
pancreas (pancreatitis) in the past year or have long term (chronic) pancreatitis - Have another cancer that requires treatment
- Have problems with bleeding
- Have a serious infection caused by a bacteria or fungus
- Are HIV, hepatitis B or hepatitis C positive
- Are known to be sensitive to sorafenib or any of its ingredients
- Are taking medication that could affect the way sorafenib works in your body – your doctor can confirm this
- Are taking a drug called warfarin to thin your blood
- Are having drugs that kills cells (
cytotoxic ) - Have any other medical or mental health condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
Trial design
This trial will recruit up to 10 people who attend clinics at either Derriford Hospital, Plymouth or the Wellcome Trust Clinical Research Facility, Manchester. Everyone taking part will have sorafenib.
Sorafenib is a capsule. You take it with a glass of water on an empty stomach. You cannot eat or drink, apart from water, for 2 hours before taking sorafenib or for 1 hour afterwards. You should not have grapefruit or drink its juice while taking sorafenib.
You take sorafenib for 11 days. You to take 1 or 2 capsules twice a day for 10 days, in the morning and evening, about 12 hours apart. On the 11th day you take it in the morning only. You have a diary card to record the date and time you take sorafenib.
The researchers will ask you to fill in 2 different questionnaires several times during the study. They will ask you about any pain you may have in your schwannomas.
The researchers will also ask to take some samples of tissue from your tumour before and after the treatment. They will also take some blood samples. They will use these to find out how sorafenib works in the body and how much gets into the schwannomas.
People recruited at Manchester will be invited to undergo two MRI scans during the study.
Hospital visits
You see the doctor and have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG )
You see the doctor for similar tests
- Before starting treatment
- On days 7 and 11 of treatment
- And about 2 weeks after treatment (day 28)
Side effects
The most common side effects of sorafenib include
- Diarrhoea
- Feeling or being sick
- Tiredness (fatigue)
- Sore mouth
- Tummy (abdominal) pain
- Headache
- Bone pain
- Hair loss
- Flushing
- Rash or red, dry itchy skin
- Red or sore palms of the hand or soles of the feet
- High blood pressure
- Increased risk of bleeding
We have more information on sorafenib in our Cancer drugs section.
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
Professor Oliver Hanemann
Supported by
NIHR Clinical Research Network: Cancer
University Hospitals Plymouth NHS Trust
The Brain Tumour Charity
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
