A trial looking at vaccine treatment for cancers containing the Epstein Barr virus (PH1/101)

Please note this trial is no longer recruiting patients.

This trial is looking to see if a vaccine containing the Epstein Barr virus (EBV) can boost the body's immunity against EBV, in people who have had Hodgkin’s lymphoma or nasopharyngeal cancer.

The Epstein Barr virus (EBV) doesn’t cause cancer or any other medical problems in most people who are infected with it. But, although doctors don’t know why, EBV is sometimes found in cancer cells. Especially in some Hodgkin's lymphoma (Hodgkin's disease) cells and cells of cancers in the upper part of the throat (nasopharyngeal cancer). If doctors could get the body’s immune system to attack the virus, the cancer cells might be killed at the same time.

Vaccines boost the immune system’s ability to kill a particular virus by helping it recognise that virus. The vaccine in this trial might be a useful treatment for cancer, but first the doctors need to check whether it is able to boost immunity against EBV. The vaccine, called MVA-EBNA1/LMP2, contains some genetic code (DNA) from EBV that helps the immune system to recognise the virus.

In this trial, the vaccine will be given to patients who have had Hodgkin's lymphoma or nasopharyngeal cancer in the past, and the cancer contained EBV. The aims of the trial are to find out about the side effects and to find the best dose of the vaccine to give.

Recruitment

Start 24/05/2005

End 26/07/2010

Phase

Phase 1

Who can enter

You can enter this trial if you

Have had Hodgkin’s lymphoma or nasopharyngeal cancer in the past and the cancer cells contained EBV (your doctors will need to have tested a sample of your cancer cells to find this out)
Have satisfactory blood test results
Are well enough to take part in the trial
Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have had chemotherapy or radiotherapy in the last 12 weeks
Have had major surgery in the last 4 weeks
Have hepatitis B, hepatitis C or HIV
Have an autoimmune disease
Have a skin disease that needs treatment
Are allergic to vaccines or eggs
Have had a bone marrow transplant
Don't have a spleen
Are taking drugs that suppress your immune system
Have heart failure or a history of heart disease
Have any other serious medical condition
Are pregnant or breastfeeding

Trial design

This is a phase 1 trial . It will recruit between 19 and 22 patients who have had a tumour that contained EBV. All the people taking part will have the vaccine.

You will have up to 3 injections, 3 weeks apart. The first patients taking part will have the lowest dose of vaccine. If they do not have any serious side effects, the next patients will have a higher dose. And so on, until the best dose to give is found. This is called a ‘dose escalation’ study. If you have any serious side effects, the doctors will probably decide to stop treatment.

Hospital visits

The doctors will first check that your cancer contained EBV. Before you take part in the trial, you will have

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

You will have these tests again 4 weeks after your last injection.

You will go to the hospital to have the vaccine up to 3 times, 3 weeks apart. You will go back to the hospital a couple of days later so the research team can check for side effects. Or they may phone you at home to see how you are.

You will have blood tests on the day you have the injection, and 1 week afterwards.

You will see the trial doctors 3 weeks, 4 weeks and 7 weeks after your last injection. And again at 6 months and 12 months.