A trial looking at ACVA for cancers that test positive for carcinoembryonic antigen (CEA) (PH1/099)

Please note this trial is no longer recruiting patients.

This trial is looking at a new treatment called ACVA for people who have cancer of the bowel, breast, food pipe, stomach, lung, or pancreas that expresses CEA.

ACVA is a new and experimental treatment. It is a type of biological therapy known as a DNA vaccine. It is made from the tetanus vaccine, but researchers have added some new genetic material (DNA) to modify it. Because the genetic material has been changed, it is also classed as a type of gene therapy.

Some cancer cells have a protein called carcinoembryonic antigen (CEA) on the surface of the cell (they ‘express’ CEA). The research team hope that ACVA will help the immune system to recognise cells with CEA on them and kill them. But they are not sure yet how well this will work.

This trial will recruit people who have no signs of cancer following treatment (are ‘in remission’). Everybody taking part will have had cancers that express CEA. Some people with advanced cancer have taken part in this trial, but recruitment into this group has now finished.

The aims of the trial are to find out

If ACVA can stimulate the immune system to recognise and kill cancer cells that express CEA
What the side effects are
What happens to the level of CEA in the body

Recruitment

Start 01/10/2005

End 30/01/2009

Phase

Phase 1

Who can enter

You can enter this trial if you

Have had cancer of the bowel (colon or rectum), breast, food pipe (oesophagus), stomach (gastric cancer), lung or pancreas but have no signs of cancer following surgery, with or without chemotherapy (you are ‘ in remission’)

In addition to that, you must

Have a raised CEA level
Have cells in your immune system that contain HLA A2 - the research team will do a blood test to measure this
Have satisfactory blood test results
Be well enough for treatment (performance status 0, 1 or 2)
Be at least 18 years old
Be prepared to use reliable contraception during treatment and for up to 6 months afterwards if there is any chance that you or your partner could get pregnant

You cannot enter this trial if you

Have had radiotherapy in the last 8 weeks, unless it was for symptom control only
Have had chemotherapy, hormone therapy, immunotherapy, or steroid injections in the last 8 weeks
Have had major surgery in the last 3 to 4 weeks
Have an inflammatory or autoimmune condition of the bowel
Have had any other cancer in the last 5 years, apart from successfully treated carcinoma in situ of the cervix or non melanoma skin cancer (if you had another cancer at least 5 years ago and have no signs of the cancer now, you may be able to take part)
Have hepatitis B, hepatitis C or HIV
Have heart failure
Have any other serious medical condition
Are pregnant or breastfeeding

Trial design

This is a phase 1 trial of an experimental treatment. It will recruit about 30 patients into 2 groups.

One group was patients with advanced cancer (this group has now closed). The other group is patients who don’t have any signs of cancer following treatment. All patients taking part will have ACVA treatment.

You have ACVA as an injection into a muscle, either in your arm or your buttock. You have 6 injections over 12 weeks altogether - in weeks 0, 1, 2, 4, 8 and 12.

The Department of Health (DH) wants to make sure that new treatments such as DNA vaccines are safe and don’t have long term side effects. To help them do this, they will ask you if a note can be made on your National Health Service (NHS) records to say that you have taken part in this trial. You don’t have to agree to this.

In theory, gene therapy could affect any children you have in the future. So the DH would also like to make a note on the NHS records of any children you have after you take part in this trial.

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. The tests include

Blood tests
Urine test
Physical examination
Chest X-ray
CT scan
Heart trace (ECG)

You will stay in hospital for a few hours each time you have the injection, but you should be able to go home later the same day.

You will have blood tests before, during and after your treatment. You will have regular blood tests, physical examinations and possibly chest X-rays for a year after you finish treatment. They will be weekly to begin with, but will be less frequent as time goes on.

You will have a CT scan 1 year after your first injection.