A trial of TG01 with GM-CSF and gemcitabine for people who have had surgery to remove cancer of the pancreas

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 1/2

This trial is looking at using a new vaccine called TG01 with GM-CSF and gemcitabine for cancer of the pancreas. This trial is for people who have had surgery to completely remove their pancreatic cancer.

More about this trial

After surgery you may have the chemotherapy drug gemcitabine. This is to reduce the chances of your cancer coming back. It can help, but researchers are always looking for better treatments.

In this trial the researchers are looking at a new vaccine called TG01. It is a type of immunotherapy Open a glossary item. This means it uses your own immune system to kill cancer cells.

In this trial you will also have GM-CSF. GM-CSF is a growth factor that doctors sometimes use to increase the number of white blood cells in the body. The researchers think it will help TG01 to work better.

The aims of this trial are to find out

  • About the side effects of TG01, GM-CSF and gemcitabine
  • If this treatment can delay or reduce the chances of your cancer coming back
  • What the immune response is after having TG01, GM-CSF and gemcitabine together

Who can enter

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

  • You have pancreatic cancer that is adenocarcinoma Open a glossary item type
  • Your cancer was completely within your pancreas (stage 1 or stage 2)
  • Your cancer was successfully removed with surgery
  • You are able to start chemotherapy within 3 months of having your surgery
  • Your blood results are satisfactory
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

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

  • Have had treatment for pancreatic cancer apart from surgery, or chemotherapy before surgery to shrink the cancer
  • Have cancer that has spread to your brain
  • Have had another experimental drug as part of a clinical trial in the past month
  • Are taking medication that dampens your immune system unless it is a low dose of steroids or inhalers used for asthma
  • Are not able to have gemcitabine
  • Have had another cancer in the past 3 years, apart from successfully treated non melanoma skin cancer or carcinoma in situ of the cervix
  • Are planning to have a live vaccine Open a glossary item during this trial
  • Have certain heart problems (the trial team can tell you about this)
  • Are known to have tested positive for HIV, hepatitis B or hepatitis C
  • Have had a bad reaction to vaccines in the past
  • Have any other medical condition or mental health problem that the researchers think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 1/2 trial. The researchers need between 6 and 30 people to join.

There are 2 groups in this trial, group 1 and group 2. Which group you are in depends on how well your doctor feels you are after surgery.

If you are in group 1, you start TG01 and GM-CSF very soon after surgery and before you start chemotherapy. If your doctor decides not to start chemotherapy you continue to have TG01.

If you are in group 2, you start having TG01, GM-CSF and chemotherapy together within 3 months of having your surgery.

You have TG01 as an injection into the skin of your upper arm (an intradermal injection). Before each injection of TG01 you also have an intradermal injection of GM-CSF.

If you are in group 1, you have the injections 3 times during the first week, then once a week for 3 weeks, then every 2nd week until the end of chemotherapy. After chemotherapy you have injections every 4 weeks to 1 year after starting treatment and then every 12 weeks for another year. If you don’t start chemotherapy, after 10 weeks you have the injections every 4 weeks until it is a year since you started the treatment and then every 12 weeks for another year.

If you are in group 2, you have the injections 3 times in the first week, once a week for 2 weeks and then every 2nd week until the end of chemotherapy. After chemotherapy you have the injections every 4 weeks to 1 year after starting treatment and then every 12 weeks for another year.

On certain days for the first 3 months, you have another injection of TG01 in the lower part of your other arm. For 2 days after each injection, you record any skin reaction, such as redness or hardening that you may have in a diary. The researchers will tell you more about this.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

  • A physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • Urine test
  • CT scan or MRI scan

During treatment you see the doctor regularly for blood tests and a physical examination. You have a CT scan or MRI scan every 6 months.

After treatment your doctor will tell you how often they want to see you.

Side effects

In earlier trials the most common side effects of TG01 and GM-CSF were

  • Flu like symptoms such as fever, chills, shivering
  • Back pain
  • Headache
  • Feeling or being sick
  • Diarrhoea
  • Swelling
  • Skin reactions at the injection site, such as pain, reddening, swelling, thickening of the skin and itching

It is possible that you could have an allergic reaction to TG01 or GM-CSF. You have to stay at the hospital for at least 30 minutes after having the first 2 injections. If you have a reaction, you can then have treatment for it straight away.

We have information on the side effects of gemcitabine.

Your doctor will talk to you about all the possible side effects before you agree to take part in the trial.

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

Professor Dan Palmer

Supported by

NIHR Clinical Research Network: Cancer
Targovax A/S

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11768

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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