A trial looking at Reolysin with chemotherapy for advanced cancer, including head and neck cancer

Cancer type:

Head and neck cancers

Melanoma

Sarcoma

Skin cancer

Womb (uterine or endometrial) cancer

Status:

Results

Phase:

Phase 1/2

This trial was looking at a treatment called Reolysin in combination with paclitaxel and carboplatin chemotherapy for advanced cancers, including head and neck cancers.

Doctors often treat advanced cancers with paclitaxel and carboplatin chemotherapy. Researchers wanted to know if adding a drug called Reolysin would help improve the treatment outcome.

Reolysin is a treatment that uses a virus Open a glossary item called reovirus. This common virus rarely causes any symptoms. We know from research that it can kill cancer cells, but does not seem to affect normal cells.

Researchers had found that having Reolysin with a taxane drug Open a glossary item such as paclitaxel kills more cancer cells than using a taxane alone. And that a drug called cisplatin may help Reolysin to work better. Carboplatin chemotherapy is from the same family as cisplatin, but has fewer side effects. In this trial researchers used Reolysin with paclitaxel and carboplatin (PC chemotherapy).

The aims of this trial were to find out

How well Reolysin with PC chemotherapy worked for advanced cancer
More about the side effects of Reolysin and how safe it is

Summary of results

The researchers found that the cancer stayed the same or got smaller in more than half the people with head and neck cancer who had Reolysin and PC chemotherapy.

The trial recruited 31 people with advanced cancer

24 had cancer of the head or neck
4 had melanoma
2 had cancer of the womb or peritoneum
1 person had sarcoma

The trial was in 2 parts called phase 1 and phase 2. In the first part of the study (phase 1), the researchers worked out the highest dose of Reolysin that people could safely have alongside chemotherapy. This is called a dose escalation study. In phase 2, everybody had the highest safe dose that had been found in phase 1.

Everybody taking part in both phases of the trial had Reolysin and chemotherapy through a drip into a vein in 3 week cycles of treatment.

The researchers have results for the 24 people with head and neck cancer and the 4 people with melanoma.

In phase 1, the researchers could see that the cancer had got smaller (a partial response Open a glossary item ) in 2 out of 5 people with head and neck cancer.

In phase 2, 19 people with head and neck cancer had at least 2 cycles of treatment. The researchers could see that

8 people had a partial response
In 6 people, the cancer didn’t get bigger or smaller (researchers call this stable disease)
In 5 people, the cancer continued to grow

Of the 4 people who had melanoma

1 person had a partial response
1 had stable disease
In the other 2 people, the melanoma continued to grow

The most serious side effects were

A drop in the number of blood cells which can cause an increased risk of infection, bleeding and bruising problems, tiredness and shortness of breath
Low blood pressure

The researchers also looked at how long people lived after treatment. They found that on average people with head and neck cancer lived for more than 8 months. And people who had a partial response or stable disease after treatment lived for longer on average than people whose cancer had continued to grow. This difference is unlikely to have happened by chance, so is described as being significant Open a glossary item in statistical terms.

Researchers are now carrying out other trials looking at giving Reolysin alongside other types of treatment.

We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item ) or published in a medical journal yet. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.