A trial of OncoVEX GM-CSF for melanoma that cannot be removed

Please note this trial is no longer recruiting patients.

This trial is looking at a treatment called OncoVEX GM-CSF for melanoma that has either not been treated yet, or has come back after earlier treatment, and cannot be removed with surgery .

The treatment uses a form of the cold sore virus that has been changed so that it is not harmful to normal cells, but destroys cancer cells. The normal strain of the virus is changed by altering the genes that tell the virus how to behave. OncoVEX GM-CSF works in 2 ways

It puts the changed virus directly into cancer cells where it can grow and kill them
It tells the body to make more of a substance called GM-CSF

GM-CSF stands for 'granulocyte and macrophage colony stimulating factor'. It is a growth factor that can encourage the immune system to recognise and attack cancer cells. Small amounts of GM-CSF are produced naturally in the body. But you can have larger amounts by injection.

In this trial, some people will have injections of GM-CSF and some will have OncoVEX GM-CSF. Doctors inject OncoVEX GM-CSF directly into the melanoma. This is called intratumoural treatment. The researchers hope that the virus will kill cancer cells and the GM-CSF will boost the immune system to help fight the cancer.

The aims of the trial are to

See how well OncoVEX GM-CSF works for melanoma
Learn more about the side effects

Recruitment

Start 01/05/2009

End 13/06/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have melanoma that is stage 3b, 3c or 4 and cannot be removed with surgery
Have melanoma that can be measured and is at least 10mm in size if it is a single tumour, or adds up to at least 10mm if there are a number of tumours
Have at least 1 area of melanoma that doctors can inject into directly
Have satisfactory blood test results
Are well enough to take part in the trial (performance status of 0 or 1)
Are at least 18 years old
Are willing to use reliable contraception during the trial and for 1 month after the end of treatment if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have melanoma that started in the eye or in the moist tissues lining the inside of the body, such as the mouth (mucosal melanoma)
Have melanoma that has spread to your brain unless this has been treated with stereotactic radiotherapy or surgery, there are no signs of it getting worse and you have not needed steroids for at least 2 months
Have melanoma that has spread to your bones
Have more than 3 areas of melanoma inside your body other than melanoma that has spread to your lungs or lymph nodes
Have any area of melanoma that is bigger than 3cm in size
Have melanoma that has spread to your liver, unless it has been treated and has not grown (stable disease) for at least a month
Have had any other cancer unless it has been successfully treated and there is now no sign of disease
Have already had OncoVEX GM-CSF or GM-CSF to treat melanoma
Take steroids on a regular basis (it is important that you don’t stopping taking steroids without talking to your doctor)
Are taking part in another clinical trial or have had another experimental drug in the last 4 weeks
Have certain heart problems that show on a trace of your heart (the trial doctors will advise you about this)
Have a skin infection caused by the herpes virus or take medication for herpes such as aciclovir
Have any other medical condition that could affect you taking part in this trial
Are known to be HIV positive or have hepatitis B or hepatitis C
Are pregnant or breastfeeding

Trial design

This is a phase 3 trial that will recruit about 430 people in the UK and other countries. It is a randomised trial. The people taking part are put into treatment groups by computer. Neither you, nor your doctor can decide which group you are in. There will be twice the number of people in group 1 as in group 2.

People in group 1 have OncoVEX GM-CSF as an injection directly into the melanoma. You can have some cream rubbed on your skin to make the area numb first.

People in group 2 have injections of GM-CSF just under the skin, but not directly into the cancer. The trial team will teach you to give yourself the injections at home. Or, if you prefer, they can show a friend or family member how to do this.

Everybody taking part will be asked to complete a questionnaire every 4 weeks during treatment and at the end of treatment. The questionnaire will ask you about any side effects you have had and about how you are feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Heart trace (ECG)
Blood and urine tests
CT scan
PET scan
Ultrasound scan

The researchers will take photographs of any areas of melanoma they can see.

If you are in group I, you go to hospital each time you have treatment. You have to stay at the hospital for at least 4 hours after the first treatment. You have the next treatment 3 weeks later and then every 2 weeks after that. If it is helping, you can carry on having OncoVEX GM-CSF for up to a year. But you may stop sooner if the cancer disappears completely, or if the cancer gets worse.

If you are in group 2, you have the first GM-CSF injection in hospital and have to stay for at least 4 hours afterwards. After that, you have the injections at home. You have an injection every day for 2 weeks, followed by 2 weeks without treatment, before starting again. You go to hospital to see the trial team every 2 weeks. You can carry on having treatment for up to a year, but treatment will stop sooner if the cancer gets worse.

People in both groups have more blood tests throughout the treatment, and a

CT scan every 3 months
MRI scan every 4 months

After 9 months of treatment you may have a PET scan. The doctors may also want to take a biopsy at some point during your treatment.

You go back to see the trial doctors a month after you finish treatment. They will examine you and take more photographs and blood tests. The trial team will continue to follow your progress for 2 years after you finish a year of treatment.

Side effects

The side effects of OncoVEX GM-CSF include

Fever or chills
Muscle aches and flu like symptoms
A drop in the number of red blood cells that can cause tiredness and shortness of breath
Headache
Loss of appetite
Sickness
Diarrhoea or constipation
Feeling drowsy
Tiredness (fatigue)