A trial looking at a drug called OncoVEX GM-CSF with radiotherapy and cisplatin for head and neck cancer (004/04)

Cancer type:

Head and neck cancers




Phase 1/2

This trial was to find out more about a new biological therapy called OncoVEX GM-CSF to treat head and neck cancer.

Doctors usually treat head and neck cancer with surgery, radiotherapy or chemotherapy.

OncoVEX GM-CSF was injected directly into the cancer. The treatment used a virus which had been changed to make a natural substance called GM-CSF Open a glossary item. The virus was a form of the common cold sore virus. The normal strain of the virus had been changed so that it was unlikely to be at all harmful, except to cancer cells.

The researchers hoped that the virus would kill cancer cells and the GM-CSF would boost the immune system to help fight the cancer.

In this trial they were using OncoVEX GM-CSF alongside radiotherapy and chemotherapy. The aims of the trial were to find out

  • The best dose of OncoVEX GM-CSF to give
  • How well OncoVEX GM-CSF worked alongside radiotherapy and chemotherapy for advanced head and neck cancer

Summary of results

The trial team worked out the highest dose of OncoVEX GM-CSF that could be given safely in this situation. They also found that by having these injections alongside standard treatment, cancer came back in fewer people than would usually be expected.

The trial recruited 17 people who had a head and neck cancer that had spread to their lymph nodes Open a glossary item. Everybody taking part had treatment with radiotherapy and cisplatin chemotherapy.

The researchers also injected OncoVEX GM-CSF directly into each person’s cancer on up to 4 separate occasions.

  • Scans showed that the cancer had got smaller or disappeared in 14 people
  • Out of 15 people who had surgery to remove the lymph nodes in the neck (a neck dissection), the researchers found cancer in the lymph nodes of only 1 person

The trial team followed up the people in the trial for an average of just under 2 ½ years. They found that the cancer hadn’t come back in the head and neck area in any of the people taking part, but in 4 people, the cancer had spread somewhere else in the body.

The researchers concluded that OncoVEX GM-CSF injections can be given safely alongside radiotherapy and chemotherapy. Although this study was small, cancer did respond to treatment in 14 people. So the researchers plan to look at this treatment in trials involving larger numbers of people.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr K Harrington

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Last review date

CRUK internal database number:

Oracle - 627

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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