"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at selumetinib for people with Kaposi's sarcoma (SCART)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Sarcoma
Status:
Closed
Phase:
Phase 1/2
This trial wants to find out the best dose of selumetinib to give, and how well it works for people who have Kaposi’s sarcoma and are having treatment for HIV. This trial is supported by Cancer Research UK.
More about this trial
Kaposi’s sarcoma can be related to HIV infection. Doctors can treat Kaposi’s sarcoma with chemotherapy or interferon. Sadly the cancer can come back.
In this trial, doctors want to give people with Kaposi’s sarcoma a drug called selumetinib, provided they are also having treatment for HIV.
Selumetinib is a type of biological therapy called a 
. MEK is a body protein that sends signals to cells telling them to divide and grow. Blocking MEK may also stop cancer cells growing.
The aims of this study are to find out
- The best dose of selumetinib to give with treatment for HIV
- How well selumetinib works to treat Kaposi’s sarcoma in people also having HIV treatment
Who can enter
You may be able to enter this trial if you
- Have been having HIV treatment for 3 months or longer
- Have Kaposi’s sarcoma that can be measured
- Have Kaposi’s sarcoma that is getting worse
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during treatment and for 4 weeks after if you are a women and 16 weeks if you are a man 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 already had treatment with a drug that is a Ras, Raf or MEK inhibitor (you can check this with your doctor)
- Have an infection that needs treating (apart from HIV)
- Have raised blood pressure and you can’t have blood pressure medicine or it hasn’t helped
- Have problems with your heart
- Have had major surgery in the last 4 weeks
- Have difficulty taking or absorbing tablets, for example because you feel sick or have inflammatory bowel disease
- Have had treatment on a trial in the last 28 days
- Are pregnant or breastfeeding
There is some evidence that in people of Asian origin process and get rid of selumetinib in a different way. This means the amount of selumetinib in their cells may get very high and this may cause serious side effects.
People of Asian ethnicity are not excluded from this study. But your doctor will make a clinical judgment as to whether the potential risk of higher levels of selumetinib outweighs the potential benefit of treatment.
Trial design
This is a phase 1/2 trial. Whether you take part in phase 1 or phase 2 depends on when you join the trial.
Phase 1 of the trial aims to find the best dose of selumetinib. It will recruit about 12 people. The first people taking part will have the lowest dose of selumetinib. If they don’t have any serious side effects, the next people will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
Phase 2 of this trial is looking at how well selumetinib works in Kaposi’s sarcoma. It will recruit about 25 people.
You take selumetinib tablets daily, your doctor will explain how. You will be able to carry on taking selumetinib as long as it continues to help you.
If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to diagnose your cancer. They will ask for another sample 6 weeks after you join the trial.
Hospital visits
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Photographs of Kaposi’s sarcoma of the skin
- Blood pressure
- Heart trace (
ECG ) - Heart ultrasound (
echocardiogram ) or MUGA scan - Eye tests
- Blood tests
- Chest X-Ray
- CT scan
While you are taking selumetinib you see the doctors and have blood tests often. You may have a CT scan every 6 weeks to monitor your disease.
When you stop treatment you see the doctors and have blood tests. You then see the trial team every 3 months for blood tests. Some people will continue to have CT scans every 3 months. Your doctor will discuss this with you.
Side effects
As selumetinib is a new drug, there may be side effects that doctors don’t know about yet. Possible side effects include
- A rash
- Feeling or being sick
- Diarrhoea
- Tiredness (fatigue)
- Loss of appetite
- Mouth sores
- An increased in blood pressure
- Blurred vision
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Dr Robin Young
Supported by
AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sheffield Teaching Hospitals NHS Foundation Trust
University of Birmingham
Other information
This is Cancer Research UK trial number CKUKD/11/005.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
8137
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
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