A trial looking at T cell therapy for cancer of the oesophagus or stomach (ATTACK-OG)

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

Cancer type:

Oesophageal cancer
Stomach cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at using cells from your own immune system to treat stomach cancer or cancer of the food pipe (oesophageal cancer). It is for people who have cancer that has spread to another part of the body.

Doctors often treat cancer of the stomach and cancer of the oesophagus with surgery, chemotherapy or radiotherapy. But sometimes the cancer continues to grow. Doctors hope that using T cells from your own immune system might be useful in this situation.

More about this trial

In this trial, doctors will remove some immune system cells called T cells from your blood.  The research team will change (modify) the T cells by adding a gene Open a glossary item that helps them recognise cancer cells which produce the NY-ESO-1 protein. These modified T cells are called NY-ESO-1 specific T cells.

After your T cells have been removed, you have some chemotherapy. This is to temporarily reduce the number of other immune cells, because they may attack the modified T cells. Then you have your T cells back through a drip into a vein. Researchers hope these modified cells will recognise and attack any cancer cells.

The aim of this trial is to see how well this type of T cell therapy works for oesophageal or stomach cancer, and what the side effects are.

Who can enter

You may be able to join this trial if all of the following apply. You

  • Have cancer of the oesophagus or cancer of the stomach that has spread to another part of your body, apart from to your brain or spinal cord
  • Have already had chemotherapy for your cancer
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have white blood cells which have markers called HLA-A*0201 on them (your doctor can tell you more about this)
  • Have cancer cells which contain the NY-ESO-1 antigen (your doctor can tell you more about this)
  • Have good heart function
  • Have satisfactory blood test results
  • Are willing to use reliable contraception for 4 weeks before, during and indefinitely after treatment if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have had other cancer treatment such as biological therapy, chemotherapy or radiotherapy in the last 4 weeks
  • Have had treatment with drugs called nitrosureas Open a glossary item or a drug called mitomycin C in the last 6 weeks
  • Have had radiotherapy to more than a quarter of your bones (your doctor can confirm this)
  • Are still having side effects from earlier treatment (apart from a very mild side effects or hair loss)
  • Have taken part in another clinical trial in the last month
  • Have had a stem cell transplant using your own cells (an allogeneic transplant)
  • Have certain serious heart problems (your doctor can tell you more about this)
  • Have an infection that needs treatment
  • Need to take steroids or other drugs which damp down your immune system
  • Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
  • Have HIV, hepatitis B, hepatitis C or a virus called HTLV (human T-cell lymphotropic virus)
  • Have a condition that affects your immune system (the doctors can tell you more about this)
  • Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The research team would like about 28 people with cancer of the oesophagus or stomach to take part. Everyone taking part will have the same treatment.

To begin with, the trial team need to remove some T cells from your blood. To do this, they put a small tube into one of your veins (usually in your arm). Blood passes down the tube and through a machine called a cell separator which removes the T cells. The rest of your blood is then returned to you via a tube into another vein (usually in your other arm). This will take around 3 hours.

The researchers will then use gene therapy to change (modify) these cells in the laboratory, to make them able to recognise and attack cancer cells.

Before the next part of the trial you will have a central line put in. A central line is a small plastic tube which goes under the skin and into a vein under your collar bone. It will stay in place until you finish treatment. This makes it easier to give treatment and take blood samples.

Then you will have fludarabine and cyclophosphamide chemotherapy. You have cyclophosphamide for 2 days, and then fludarabine for 5 days. You have both drugs through your central line. Doctors call this part of the treatment pre conditioning. The aim is to reduce the number of other immune system cells so that the modified T cells work better.

After you finish chemotherapy you will have your T cells back through your central line. This takes about half an hour.

About an hour later you will have a type of immunotherapy called interleukin 2 (IL2), also through your central line. You will have up to 12 doses over 4 days, and each one takes about 15 minutes. Doctors hope that the IL2 will help the T cells work better.

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. The tests include

  • Physical examination
  • Blood tests
  • Urine test
  • Heart trace (ECG Open a glossary item)
  • Chest X-ray
  • CT scan
  • Heart scan (MUGA Open a glossary item) or echocardiogram (ECHO) Open a glossary item

During treatment you will have regular blood tests. You will stay in hospital while you have treatment and for a little while afterwards, so that the research team can keep an eye on you. You will probably be in hospital for a couple of weeks altogether.

After your treatment, you will see the research team

  • Every 2 weeks for 6 weeks
  • Every 4 weeks for another 6 months
  • Every 3 months for a another year
  • Every 6 months after that

You will have a CT scan 6 weeks and 12 weeks after treatment, and then every 12 weeks after that.

Side effects

This is a new treatment so there may be side effects we don’t know about yet.

A possible side effect could be an allergic reaction to the NY-ESO-1 specific T cells causing symptoms such as a rash, low blood pressure or wheezing.

There is a chance that the T cells will attack other cells that are not cancer cells. If this happens, it could cause other side effects. For example, if the T cells attack other cells in the immune system, you may have an increased risk of infection.

The most common side effects of interleukin 2 include

  • Flu like symptoms such as fever, chills, headaches and aching muscles
  • A drop in blood cells causing an increased risk of infection, tiredness, bleeding problems and shortness of breath

The most common side effects of cyclophosphamide and fludarabine include

We have more information on the side effects of

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 Fiona Thistlethwaite
Prof Stefan Sleijfer

Supported by

European Commission’s FP7 health programme
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Christie NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10679

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think