A trial of SCIB1 injections for melanoma

This trial is looking at a type of immunotherapy called SCIB1 for people with melanoma.

Doctors often treat melanoma with surgery. But sometimes melanoma cannot be completely removed with surgery because it has spread to another part of the body. Or, even when it is completely removed, it can sometimes come back. Doctors are looking for new treatments to help people in this situation.

This trial is looking at a new treatment called SCIB1. It is a liquid that contains small pieces of DNA. The researchers hope that SCIB1 will activate cells in the immune system so that they attack melanoma cells.

The aims of the trial are to

Find the highest safe dose of SCIB1
See what effect it has on your immune system

The results of this study will be used to design more trials that will test how well SCIB1 works as a treatment for melanoma.

Recruitment

Start 28/05/2010

End 30/06/2012

Phase

Phase 1/2

Who can enter

You can enter the 1st part of this trial if you

Have melanoma that is stage 3 or stage 4

You can enter the 2nd part of this trial if you

Have melanoma that is stage 3 or stage 4, and you have had surgery to remove your melanoma in the last 6 months

And for both parts of the trial, you can enter if you

Have melanoma that makes certain proteins (antigens) that your immune system can recognise, including one called HLA-A2 (the trial doctors can advise you about this)
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 at least 18 years old
Are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or partner could become pregnant

You cannot enter this trial if you

Have cancer that has spread to your brain
Have had steroids or other cancer drugs that circulate throughout the body (systemic treatment) in the last 4 weeks
Have had another experimental drug as part of a clinical trial in the last 4 weeks
Have had any other type of cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that has been successfully treated
Have a very slow heart rate or an abnormal heart rhythm
Have a pacemaker or other electronic medical device in your body
Have any other medical condition that could affect you taking part in this study
Have a skin fold measurement greater than 40mm (this is a measure of how much fat you have under the skin of your upper arm or thigh)
Are pregnant or breastfeeding

Trial design

This trial will recruit about 22 people. Everybody taking part will have SCIB1 injections. Each time you have treatment, you have one injection into the muscle in your arm, and one into the muscle in your thigh. A doctor or nurse gives the injections using a special device. This injects the SCIB1 and then gives a short electrical impulse that lasts about half a second.

The first few people taking part in the trial will have a low dose of SCIB1. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until the researchers find the highest dose they can give safely. This first part of the trial is called a ‘dose escalation study’.

Once the researchers have worked out the highest safe dose, the rest of the people joining the 2nd part of the trial will have this dose.

Everybody taking part will have 5 injections of SCIB1 over a period of nearly 6 months.

The trial team will ask you to fill out a questionnaire after each treatment. This will ask about your experience of having this type of injection.

Hospital visits

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

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

You will go to hospital 12 times all together during the trial. If your melanoma has not been removed by surgery you will have 2 more visits to the hospital and 3 extra CT scans.

After you finish treatment, the trial team will contact you by phone to see how you are. They will ring you 3 times in the first year and then once a year for up to 4 more years.

Side effects

When you have the SCIB1 injections, you will feel a twitching in your muscle which might be painful. And your arm and leg will be sore to the touch after the treatment.

You may bleed a little after the injection and then a scab may form. The skin around the injection sites may become red and you might have bruising or swelling. The next time you have the injections, they will be on the other side of your body.

As SCIB1 is a new treatment, there may be side effects we don’t know about yet. From trials of similar treatments, we know possible side effects include

Dizziness or fainting when you have the injections
An immune response that can cause a loss of pigment in the skin (a condition called vitiligo) or a swelling (inflammation) of the eye that could affect your sight
An allergic reaction causing fever or chills and flu like symptoms
Muscle damage or infection at the injection site