A trial of Oncovex gene therapy for melanoma and other cancers that have spread to the skin

Cancer type:

Bowel (colorectal) cancer

Breast cancer

Head and neck cancers

Melanoma

Oesophageal cancer

Pancreatic cancer

Skin cancer

Stomach cancer

Status:

Results

Phase:

Phase 1

This trial was looking at a type of cancer vaccine called OncovexGM-CSF for melanoma skin cancer and other cancers that had spread to the skin. It was a very early trial that tested this treatment for the first time in people.

More about this trial

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.

So that the researchers could easily see the effect the virus had on cancer, the trial was only open to people who had nodules (lumps) of cancer on their skin. As well as melanoma skin cancer, skin nodules can develop in bowel cancer, head and neck cancer, oesophageal cancer, pancreatic cancer, breast cancer and stomach cancer.

Doctors injected the treatment directly into the tumours in the skin (intratumoural treatment Open a glossary item ).

The aim of the trial was to see how the treatment affected cancer cells in the skin nodules and how safe it was.

Summary of results

The researchers found that Oncovex could be safely injected into skin nodules and some cancers responded to the treatment.

The trial recruited 30 people.

13 people had a single injection of Oncovex. The first 4 people had a low dose. As they didn’t have any side effects other than mild flu like symptoms, the next 4 people had a higher dose and so on, for 3 different doses.

48 hours after the injection, the researchers took a sample of cells from the treated skin nodule using a fine needle (FNA Open a glossary item ). And 2 weeks later, they took a biopsy .

17 people had 3 injections, between 1 and 3 weeks apart. Again, the researchers looked at 3 different doses. They took a biopsy after the last injection.

The trial team had results for 26 patients. In 14 people, the biopsy taken after treatment contained cancer cells that had died

In 3 people the cancer stayed the same size – researchers call this stable disease
In 6 people, skin nodules got smaller (flatter), but the cancer continued to grow elsewhere in the body
In 17 people, the cancer did not respond to the treatment

The most common side effects were redness or swelling at the injection site and flu like symptoms.

The researchers found that having more than one injection worked better than having a single injection. They used their results to work out the best dose to use in future trials of Oncovex for specific types of cancer.

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.