Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at a new combination of drugs for some types of leukaemia and lymphoma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at 2 drugs called bezafibrate and medroxyprogesterone to treat several different cancers. Bezafibrate is a drug for lowering cholesterol and medroxyprogesterone is a steroid. The trial is testing this combination on
- Acute myeloid leukaemia (AML)
- Myelodysplastic syndromes (MDS)
- Chronic lymphocytic leukaemia (CLL)
- B-cell non Hodgkin lymphoma
Doctors usually treat these with chemotherapy and occasionally radiotherapy. But sometimes the cancer starts to grow again. When this happens it is often more difficult to treat.
Doctors know from previous research that bezafibrate and medroxyprogesterone may stop cancer cells growing.
The aims of this trial are to find out
- If bezafibrate and medroxyprogesterone together help to treat these conditions
- About the side effects
Who can enter
You may be able to enter this trial if you
- Are being treated in the West Midlands
- Have acute myeloid leukaemia (AML), high risk myelodysplasia (MDS), chronic lymphocytic leukaemia (CLL) or B cell non Hodgkin lymphoma
- Have satisfactory blood test results
- Are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have kidneys that are not working properly
- Are known to be allergic to the drugs in the trial
- Have had treatment on a trial in the last month
- Are taking drugs to lower your cholesterol (statins) and you are unable to stop taking them while you are on the trial
- Are unable to swallow tablets
- Have fits that are not controlled with tablets
- Have an infection that is being treated with antibiotics
- Have a medical condition that would make it unsafe for you to take part in this trial
- Have problems with your gall bladder
- Have certain heart problems
- Have abnormal vaginal bleeding (if you are a woman)
- Have a blood clot (DVT) or have had one in the past
- Have had a heart attack in the last year
- Have early stage breast cancer
- Are pregnant or breastfeeding
About 60 people will take part in this study from the West Midlands area.
Everyone taking part will take bezafibrate and medroxyprogesterone tablets daily. You continue to take the tablets for as long as your doctor thinks they are helping you.
The trial team will ask you to fill out a questionnaire before you start treatment and twice during it.
This questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will take extra blood and urine samples. They will use these samples to look at why the treatment may work better for some people than others.
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- Bone marrow test (if you don’t want a bone marrow test you can still take part in the trial)
- CT scan (only for people with non Hodgkin’s lymphoma)
- Urine test
You will see the doctors and have blood and urine tests frequently for the first 18 weeks of treatment.
After 18 weeks you will see the doctors and have a bone marrow test (if you had one before treatment). If you have non Hodgkin’s lymphoma you will have a CT scan.
You continue to take the tablets if they are helping you. Your doctor will talk to you about how often you need to visit the hospital.
When you stop treatment you will continue to see your cancer doctor as usual, but there will be no more hospital visits as part of the trial.
The most common side effects of bezafibrate and medroxyprogesterone are
- Loss of appetite
- Feeling or being sick
- Aching muscles
- Weight gain
Women may have breast tenderness and abnormal vaginal bleeding.
How to join a clinical trial
Dr Mark Drayson
Cancer Research UK Clinical Trials Unit
Experimental Cancer Medicine Centre (ECMC)
Queen Elizabeth Hospital Birmingham
University of Birmingham