A trial of MetXia-OB83 and cyclophosphamide for advanced pancreatic cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Pancreatic cancer

Status:

Closed

Phase:

Phase 1

This trial is looking at a type of gene therapy called MetXia-OB83 (MetXia), and the chemotherapy drug cyclophosphamide. MetXia is a new treatment that is not licensed yet.

Doctors usually treat pancreatic cancer with chemotherapy or surgery, but unfortunately it can be difficult to treat.

The genetic material (DNA) within each cell controls the cell by telling it which proteins to make. In this trial, a virus carries a new piece of DNA into the cancer cells. The researchers have treated the virus so it will not cause an infection.

The new DNA tells the cell to make an enzyme Open a glossary item called cytochrome P-450 (usually made in liver cells). This enzyme makes cyclophosphamide more active. In theory, when the cyclophosphamide comes into contact with the cytochrome P-450 inside the pancreatic cancer cell, it will kill the cell.

A small number of patients with breast and ovarian cancer have had MetXia as a drip into a vein as part of other clinical trials. But in this trial patients with advanced pancreatic cancer will have MetXia through an injection into an artery. This is a new and experimental way of giving MetXia, and doctors don’t know yet how well it will work. Or what the side effects will be.

The aims of this trial are to

See how well MetXia and cyclophosphamide work for pancreatic cancer
Find out more about the side effects
Find the best dose of both MetXia and cyclophosphamide to use when they are given together

Who can enter

You can enter this trial if you

Have stage 3 or 4 cancer of the head of the pancreas
Are well enough to take part
Have satisfactory blood test results

You cannot enter this trial if you

Have had an operation in the last 2 weeks
Have had chemotherapy or radiotherapy in the last 4 weeks
Have any other cancer
Have any other serious medical condition
Are pregnant or breastfeeding

Trial design

This is a phase 1 trial of an experimental treatment. All the people taking part in the trial will have MetXia and cyclophosphamide. The trial is being done in 2 parts. Part 1 has now finished recruiting patients. So if you join the trial you will be in part 2 of the trial.

Part 1
In this part of the trial, 6 patients were recruited who were due to have surgery to bypass a blockage in the pancreas or bowel. They all had a dose of MetXia before their surgery and another after surgery. The first 3 had a lower dose of MetXia than the second 3. All then had up to 6 cycles of the chemotherapy drug, cyclophosphamide.

Part 2
There will be 21 patients recruited to the second part of this trial. It involves 2 different ways of giving MetXia and cyclophosphamide. Some people will have treatment through a portacath. And some people will have treatment through a drip into the artery in the groin (intra arterial). How you have the treatment will depend on individual circumstances.

People who have a Portacath
If you need to have an operation to bypass a blockage in your pancreas or bowel, your doctors may put in a portacath during the operation. This is a small chamber that sits under your skin just below your ribs on your right hand side. The chamber is attached to a thin tube which goes into the artery in your pancreas. You will have your treatment through the portacath.

Up to 6 weeks after your operation you will have MetXia through the portacath. All patients in part 2 will have the same dose of MetXia. 2 to 3 days later you will have cyclophosphamide through the portacath. You will have cyclophosphamide once every 3 weeks (1 cycle), up to 6 times. This takes about 24 hours each time.

People who do not have a Portacath
If you don’t need an operation, or you cannot have a portacath, you may have treatment through an artery in your groin (intra arterial). You will go to the X-ray department and have a small tube (catheter) put into the groin. The catheter goes up into the artery in your pancreas. You will have one dose of MetXia through an injection into the artery. The doctor will then remove the catheter.

2 or 3 days later you will have another catheter put into the artery in your groin. You will have cyclophosphamide through this catheter. You will have cyclophosphamide once every 3 weeks (1 cycle), up to 6 times. This takes about 24 hours each time. You will have a new catheter put into your artery for each treatment.

Whichever way you have the treatment, the first patients recruited into Part 2 will have the same dose of cyclophosphamide given to patients in part 1. But the next patients will have a higher dose. And so on, until the doctors find the best dose of cyclophosphamide to give with MetXia.

Hospital visits

You will go to the hospital for tests before you take part in this trial. These include

Blood tests
Urine test
Heart trace (ECG)
CT scan
Physical examination

You will have blood tests every week while you are having treatment. You will have a CT scan after every 3 cycles of cyclophosphamide. And possibly every 3 months after you finish treatment, depending on how well the treatment works.

You may need to stay in hospital overnight for each dose of cyclophosphamide. If you have a portacath, this will be removed after you have finished all your treatment.

You will see the trial doctors a month after your last dose of cyclophosphamide. You will have blood tests, an ECG and a physical examination. After that you will see the doctors every 3 to 4 weeks.

Side effects

Based on lab research and results of trials using similar treatments, the doctors running the trial do not think that intra-arterial MetXia will have any side effects. But this is a new treatment, so there may be side effects they are not expecting.

The side effects of cyclophosphamide are

Irritation to the lining of the bladder
A drop in white blood cells causing an increased risk of infection
Feeling or being sick
Loss of fertility

It is more common for doctors to give this drug as a tablet or into a vein, rather than into an artery. But the side effects will be much the same. There is more information about cyclophosphamide on CancerHelp UK.