"He went through six operations and was placed on a clinical trial so he could try new treatments.”
A trial looking at using bevacizumab for grade 2 or 3 gliomas that have come back (The TAVAREC Trial)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at combining bevacizumab (Avastin) with temozolomide (Temodal) for a type of brain tumour called a grade 2 or 3 glioma. It is for people whose glioma has come back after treatment.
Doctors initially treat grade 2 or 3 gliomas with surgery, and radiotherapy. But the tumour can start to grow again. When this happens doctors may treat it with a type of chemotherapy call temozolomide.
Bevacizumab is a biological therapy called a monoclonal antibody. It works by targeting a protein on the cancer cell called vascular endothelial growth factor (VEGF). This protein helps cancers to grow new blood vessels, so they can get food and oxygen to grow and survive. Blocking this protein may help stop cancers growing. Research has suggested that bevacizumab may be useful to treat gliomas that have come back.
The researchers will compare temozolomide and bevacizumab with temozolomide alone. They want to find out if bevacizumab is helpful or not to treat grade 2 or 3 gliomas that have come back.
Who can enter
You may be able to enter this trial if
- You have a type of brain tumour called an astrocytoma, oligodendroglioma or oligoastrocytoma that has come back
- Your brain tumour is grade 2 or 3 – your doctor can confirm this
- On a scan there is a sign that your tumour is growing new blood vessels
- You have satisfactory blood test results
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have a grade 4 glioblastoma
- Have had more than 1 course of chemotherapy treatment
- Have had your chemotherapy in the last 6 months
- Have had radiotherapy in the last 3 months
- Have had an experimental drug as part of a clinical trial in the last month
- Have already had bevacizumab, or a similar drug
- Have had surgery or a major injury in the last month
- May need major surgery while taking part in this trial
- Have had another cancer in the past 5 years apart from basal cell skin cancer, squamous cell skin cancer and carcinoma in situ of the cervix
- Have had a heart attack in the last 6 months
- Have a serious heart problem such as congestive heart failure
- Have high blood pressure that is not controlled by medication
- Have a problem with bleeding or how your blood clots
- Have had a blood clot in the last year such as a deep vein thrombosis (DVT) or a blood clot on the lung (pulmonary embolism – PE)
- Have had a stroke in the last 6 months
- Have coughed up blood in the last month
- Are sensitive to bevacizumab, temozolomide or their ingredients
- Have any other medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
If you are in group 1, you will have temozolomide alone. If you are in group 2, you will have temozolomide and bevacizumab.
Temozolomide is a tablet. You take these on an empty stomach, for example 1 hour before food or 1 hour after food. You take them once a day for 5 days out of 4 weeks. Every 4 week period is called a cycle of treatment. You can have up to 12 cycles.
If you are in group 2, after finishing temozolomide you may continue to have bevacizumab for as long as it is still helping you.
The researchers will ask you to fill in a questionnaire. It will ask about how you have been and any side effects you might have. You fill it in before starting treatment and then again every 3 months until your tumour begins to grow again. This is called a quality of life study.
The researchers also want to find out what your carer thinks about your quality of life. So they will ask the family member, or close friend who cares for you the most to fill in these questionnaires as well.
The researchers will also ask your permission to take a small piece of the tumour tissue removed when you had your original surgery. They will study these to find out more about how the treatment works and if there are particular changes in the tumour that are linked to a better response to the study treatment. You don’t have to agree to take part if you don’t want to. You can still take part in the main trial.
You will see the doctor and have some tests before taking part in the trial. These may include
- A physical examination
- Blood tests
- Heart trace –
- MRI scan
- Urine test
During treatment you will have
- Blood tests and a urine test every 2 weeks
- A physical examination and heart trace (if needed) every 4 weeks
- MRI scan every 3 months
After treatment you see the doctor every 3 months and have a MRI scan.
The most common side effects of temozolomide include
- Feeling or being sick
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Fever and chills
- Upset stomach
- Increased risk of blood clots
- Loss of appetite
- Weight loss
- Rash, itchy skin
- Liver changes
The most common side effect of bevacizumab can include
- Muscle and joint pain
- Sensitive skin
- Pain, redness and swelling of the mouth, nose and sinuses
- High blood pressure
- Kidney changes
- Shortness of breath
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.
Dr Sara Erridge
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
F.Hoffmann-La Roche Ltd (Roche)
NIHR Clinical Research Network: Cancer