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A trial of a vaccine for nasopharyngeal cancer that contains the Epstein Barr virus

This trial is looking at a vaccine that may help the immune system to recognise and kill nasopharyngeal cancer cells containing a virus called Epstein Barr (EBV). The trial is supported by Cancer Research UK.

EBV is a common virus that many people carry without noticing any effects. But the virus is sometimes found in cancer cells and is often found in nasopharyngeal cancer cells.

Vaccines can help the immune system to recognise and act against a virus. Researchers hope a vaccine that gets the body’s immune system to recognise and attack EBV might kill cancer cells containing the virus.

Doctors usually treat nasopharyngeal cancer with radiotherapy or a combination of radiotherapy and chemotherapy (chemoradiation). The people taking part in this trial have already had treatment and their cancer has responded well. Or they still have some cancer remaining, but no other treatment is appropriate or needed at this time. The vaccine, which is called MVA-EBNA1/LMP2, may make it less likely for their cancer to come back or get worse.

In an earlier trial, researchers found the highest safe dose of the vaccine you can have. In this trial, they want to learn more about

  • How your immune system responds to the vaccine
  • Side effects
  • The effect an extra dose of the vaccine has on your immune system

Recruitment

Start 01/06/2013
End 31/12/2014

Phase

Phase 1

Who can enter

You may be able to enter this trial if

  • You have nasopharyngeal cancer and tests show that the cancer cells contain the Epstein Barr virus
  • You have had radiotherapy or chemoradiation (you may have had both types of treatment)
  • There are currently no signs of cancer (your cancer is in remission), or there are still signs of cancer but there is no other standard treatment that is appropriate or that you need to have at this time
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have satisfactory blood test results
  • You are at least 18 years old
  • You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant

You may not be able to enter this trial if you

  • Have had major surgery to your chest or abdomen and have not fully recovered
  • Have had any other cancer treatment or an experimental drug in the last 6 weeks
  • Have not recovered from the side effects of earlier treatment (apart from hair loss or dry mouth) unless they are very mild
  • Have eczema or an autoimmune disease that needs treatment
  • Are allergic to eggs
  • Have ever had a bad reaction to a vaccination
  • Have had your spleen removed, have had radiotherapy to your spleen, or your doctors know that your spleen doesn’t work very well
  • Take medication that can damp down your immune system, such as steroids (steroid inhalers are allowed)
  • Have an infection that can’t be controlled with medication or another serious medical condition that the trial team think could affect you taking part
  • Have certain heart problems – the trial team can advise you about this
  • Are taking part in another clinical trial looking at an experimental treatment (or plan to do so)
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Are pregnant or breastfeeding

As well as the above, you won’t be able to take part if your specialist team think you may need to have another type of treatment in the next 3 months

Trial design

This phase 1 trial will recruit about 22 people. Everybody taking part has the MVA-EBNA1/LMP2 vaccine up to 4 times.

You have the vaccine as injections into the skin on your arms or legs. You have 3 or 4 injections each time.

You have the first 3 vaccines spaced 3 weeks apart. You then have another dose of the vaccine 12 weeks later.

Hospital visits

Before starting the trial, you see the trial team and have some tests on 1 or 2 visits to hospital. The tests include

  • Physical examination
  • Blood tests
  • CT scan and MRI scan if you haven’t had these in the last 6 weeks

You go to hospital 11 times over a year. You go 4 times to have the vaccines. You also go

  • 1 week after the 2nd dose of the vaccine
  • 1 and 3 weeks after the 3rd dose
  • 3 weeks after the 4th dose
  • A year after your first vaccine

You have blood tests at most of these visits to see if your immune system is responding to the vaccine.

Each time you have the injections, you need to stay at the hospital for at least an hour afterwards.

A nurse from the trial team will phone you to see how you are 3 days and 8 days after your first vaccine dose. If you are having any side effects, they may ask you to come to hospital to see the trial doctor.

You have a CT and MRI scan 12 weeks and 24 weeks after your first vaccine. Most people would have these scans as part of standard care after treatment for nasopharyngeal cancer.

Side effects

As the MVA-EBNA1/LMP2 vaccine is a new treatment, there may be side effects we don’t know about yet. In earlier trials, the most common side effects were

  • Redness, swelling and itching where you have the injections
  • Mild flu like symptoms
  • Headache
  • Tiredness (fatigue)
  • Chills
  • Joint pain

The side effects tend to happen within a day of having the vaccine and usually last less than a week.

If you are still having side effects when your next vaccine is due, it may be necessary to delay the next injections until any side effects have settled down. If they don’t get better after a delay, you won’t be able to have any more injections.

Rare but serious side effects can happen after any vaccine and there is a small risk that you could have an allergic reaction shortly after having the injections. This can cause high temperature (fever) and general itching. A more serious reaction can cause shortness of breath and a drop in your blood pressure. There is no reason to think the trial vaccine is more likely to cause an allergic reaction than any other type of vaccine. But the trial team will monitor you closely for at least an hour each time you have the injections.

You may have some pain, discomfort or bruising where you have the injections and blood tests.

Location of trial

  • Birmingham
  • Cardiff
  • Glasgow
  • London
  • Manchester

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr Neil Steven

This is Cancer Research UK trial number CRUKD/13/001.

Supported by

Cancer Research UK (Centre for Drug Development)
NIHR Clinical Research Network: Cancer
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Updated: 4 November 2014