A trial of ipilimumab and temozolomide for people with glioblastoma (Ipi-Glio)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
- surgery
- then radiotherapy with temozolomide
More about this trial
- surgery to remove some or all of the tumour
- radiotherapy with temozolomide (this is called chemoradiotherapy)
- then temozolomide alone for up to 6 months (this is the adjuvant treatment)
- temozolomide (the usual treatment)
- temozolomide and ipilimumab
Who can enter
- you have a newly diagnosed glioblastoma
- you had brain surgery and doctors removed at least a fifth of the tumour (your doctor can tell you more about this)
- you started radiotherapy within 49 days (about 1 and 1/2 months) after surgery
- have completed standard radiotherapy and temozolomide (chemoradiotherapy)
- doctors think that temozolomide is a suitable treatment for you
- you are between 18 and 70 years old
- you have satisfactory blood test results
- you are well enough to carry out all your normal activities apart from heavy physical work (performance status 0 or 1)
- you are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any possibility that you or your partner could become pregnant
- you have a type of glioblastoma called multifocal (your doctor can tell you more about this)
- you had a low grade astrocytoma that turned into a glioblastoma (a secondary glioblastoma)
- your glioblastoma has spread outside the brain or to the membranes that cover the brain (carcinomatous meningitis)
- you have had any treatment apart from surgery and 6 weeks of radiotherapy with temozolomide (chemoradiotherapy)
- you take a high dose of dexamethasone (more than 3mg every day)
- you have a significant bleeding in or around the glioblastoma
- you have had another active cancer apart from non melanoma skin cancer or an early cancer (
carcinoma in situ ) of the cervix that has been successfully treated
- have an
autoimmune disease that doctors think could affect you taking part in this trial
- have lung problems such as scarring of the lungs (fibrosis)
- take, or have taken drugs that damp down your
immune system unless it was a cream, inhaler or a very small dose
- have problems with your
digestive system that doctors think could affect you taking part in this trial
- had a severe infection in the past month
- are taking part in another clinical trial or have taken part in a trial in the past 4 weeks that looked at a new treatment (interventional trial)
- have HIV
- have hepatitis B or hepatitis C
- have any other serious condition or mental health problem that the trial team think could affect you taking part
- are pregnant or breastfeeding
- are sensitive to the drugs used in this trial or any other similar drug
Trial design
- temozolomide and ipilimumab (arm A)
- temozolomide (arm B)
Temozolomide and ipilimumab (Arm A)
- take temozolomide as tablets that you swallow whole every day for 5 days
- then have a break of 23 days
- take temozolomide tablets every day for 5 days
- then have a break of 23 days
Hospital visits
- physical examination
- blood tests
- urine test (for pregnancy)
Side effects
- loss of appetite and weight loss
- watery poo (diarrhoea) or constipation
- feeling or being sick
- skin rashes, itching and changes to your skin colour
- tiredness (fatigue)
- nerve changes that can cause tingling, numbness and weakness in fingers and toes
- hair loss or hair thinning
- pain at the site of injection
- low levels of thyroid hormones that can cause tiredness, weight gain and feeling cold
- loss of fluid in your body (dehydration)
- confusion, dizziness and headaches
- problems in your eyes such as blurred vision and pain
- low blood pressure and a fast heart rate
- sweating
- shortness of breath and cough
- bleeding and inflammation of your stomach and bowel
- heartburn or indigestion
- pain in your muscles and joints
- flu like symptoms and high temperature (fever)
- changes to the way your liver works
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 Paul Mulholland
Supported by
Bristol-Myers Squibb
The National Brain Appeal
University of Oxford
University College London Hospitals
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040