A trial looking at linsitinib for advanced Ewings sarcoma (LINES)
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 a new drug called linsitinib for Ewings sarcoma. It is for people whose Ewings sarcoma has continued to grow during treatment or has come back after treatment.
More about this trial
Doctors can treat Ewings sarcoma with chemotherapy, surgery and radiotherapy. Unfortunately for some people their sarcoma doesn’t respond to these treatments or it comes back after treatment. When this happens there are very few treatments available.
Researchers think that linsitinib may be able to help people whose Ewings sarcoma has not responded to treatment or has come back. Linsitinib is a biological therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The aims of this trial are to find out
- How well linsitinib works for people with Ewings sarcoma
- More about the side effects of linsitinib
- More about how linsitinib works in the body
Who can enter
You may be able to join this trial if you are going to the Churchill Hospital in Oxford and all of the following apply
- You have Ewings sarcoma that continued to grow during treatment or came back after treatment
- You have had a scan within the last 6 months that shows your sarcoma is getting worse
- You have an area of sarcoma that a sample of tissue (biopsy) can be taken from (the trial team can advise about this)
- In the past 2 weeks you have had a PET-CT scan using the
contrast medium 
18FDG and this showed an area of sarcoma that measured at least 1cm across (your doctor can confirm this) - Your heart works well enough (your doctor will test for this)
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- You are able to swallow tablets
- You are willing to use reliable contraception during treatment if there is any chance you or your partner could become pregnant
- You are between 18 and 70 years old
You cannot join this trial if any of these apply. You
- Have sarcoma that has spread to your brain. You may be able to take part if the you have had treatment with radiotherapy or surgery, have recovered from any side effects, have not had any steroids for at least a month and have no further symptoms
- Have had a stroke in the past 6 months
- Have serious heart problems (the trial team can advise you about this)
- Have had major surgery in the past month
- Have taken part in another clinical trial in the past month
- Are taking medication that may cause a heart condition called Torsades de Pointes (you doctor can tell you this)
- Take other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
- Have had a drug that works in a similar way to linsitinib (your doctor can tell you this)
- Have another cancer apart from successfully treated carcinoma in situ of the cervix or non melanoma skin cancer
- Have hepatitis B, hepatitis C or HIV
- Have another medical condition or mental health problem that the trial team think could affect you taking part in this trial
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The researchers need 40 people across Europe to join, including 10 people from the Churchill Hospital, Oxford in the UK.
Everyone taking part will have linsitinib. You take 4 linsitinib tablets once a day, before or after a meal. You take them for 3 days each week and then have 4 days of not taking them. You have a diary to record when you take the tablets.
After 3 weeks of treatment, you have a scan to see if it is helping. You can continue to have linsitinib as long as it is helping and the side effects aren’t too bad.
The researchers will ask for a sample of your sarcoma that was removed when you had surgery or a before starting treatment. They will ask for another sample of your sarcoma during treatment. They will also ask for some blood samples before starting treatment and a number of times during treatment. They will use these samples to find out what happens to linsitinib in the body.
Hospital visits
You see the doctor to have some tests before taking part. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - Heart scan (
ECHO ) - PET-CT scan
During treatment you see the doctor every 3 weeks for a physical examination, blood tests and heart trace. You have a PET-CT scan every 6 weeks.
You see the doctor at the end of treatment for the same tests you had at the start, apart from the heart scan.
After treatment your doctor will tell you how often they want to see you.
Side effects
Linsitinib is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include
- High levels of sugar in your blood
- A change to the way your kidneys, heart and liver work
- Feeling or being sick
- Diarrhoea or constipation
- Tummy (abdominal) pain
- Indigestion
- Tiredness
- Swelling of your arms, legs, feet or hands
- Feeling weak
- High temperature (fever)
- Loss of appetite and changes to taste
- Not having enough fluid in your body (
dehydration ) - Muscle, joint and back pain
- Headache
- Numbness, tingling or pain in your hands or feet
- Dizziness
- Not been able to get to sleep or feeling sleepy
- Shortness of breath
- Cough
- Nosebleed
- Skin and nail changes, rash
- Hair loss
- Increased sweating
Your doctor will talk to you about the possible side effects before you agree to take part in this trial.
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 Andrew Bassim Hassan
Supported by
Astellas
European Commission
NIHR Clinical Research Network: Cancer
University of Oxford
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
