A trial looking at pegylated interferon to treat melanoma (EORTC 18081)

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

Cancer type:

Melanoma

Status:

Closed

Phase:

Phase 3

This trial is looking at a drug called pegylated interferon (also called peginterferon) to treat melanoma. The trial is for people with melanoma that is growing in the skin (cutaneous melanoma Open a glossary item) and is ulcerated.

More about this trial

Doctors treat melanoma by removing it with surgery. If the skin covering the melanoma is broken, doctors describe it as being ulcerated. There is a high chance of ulcerated melanoma coming back or spreading to another part of the body. But unfortunately there is no further standard treatment Open a glossary item after surgery to remove ulcerated melanoma. Researchers want to find out if peginterferon can help people in this situation.

Interferon is a drug that boosts the body’s immune system Open a glossary item. Interferon is already used to treat some people with melanoma.

Peginterferon is the pegylated Open a glossary item form of interferon. It is designed to stay in the body for a longer period of time. So a small dose of peginterferon will have the same benefit as a large dose of interferon.

To find out if peginterferon does help, the researchers want to compare people who have peginterferon after surgery with those who don’t.

The aims of this trial are to find out

  • How well peginterferon works for people with ulcerated melanoma
  • How safe peginterferon is
  • How peginterferon affects quality of life Open a glossary item

Who can enter

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

  • Have melanoma in your skin (cutaneous melanoma Open a glossary item) that is more than 1mm thick and is ulcerated (stage T2b to T4b)
  • Have had surgery to remove your melanoma
  • Have had a sample of tissue (biopsy) taken from a sentinel lymph node Open a glossary item in the past 12 weeks and there is no evidence of melanoma spread in it
  • Have satisfactory blood test results
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Are willing to use reliable contraception during treatment and for at least a month afterwards if there is any chance you or your partner could become pregnant
  • Are between 18 and 70 years old

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

  • Have melanoma that started in the mucosal tissue such as the nose and mouth (mucosal melanoma Open a glossary item) or melanoma that started in the eye (ocular melanoma Open a glossary item)
  • Have melanoma that has spread
  • Have already had the drug interferon Open a glossary item for any reason
  • Have had any other treatment for your melanoma, apart from surgery
  • Have had an experimental drug as part of a clinical trial in the past month
  • Are taking long term steroids that affect your whole body (the trial team can advise you about this)
  • Have had another cancer in the past 5 years apart from non melanoma skin cancer or cervical carcinoma in situ of the cervix that has been successfully treated
  • Have certain heart problems (the trial team can advise you about this)
  • Have a problem with your thyroid gland Open a glossary item that doesn’t respond to treatment
  • Have diabetes that isn’t controlled
  • Have certain eye problems (the trial team can advise you about this)
  • Have an autoimmune disease Open a glossary item
  • Have an infection
  • Have HIV or hepatitis
  • Have epilepsy or another major problem with your brain or spinal cord (central nervous system)
  • Have any other medical condition or mental health problem that the trial team thinks may affect you taking part in the trial
  • Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The team need 1,200 people to join.

It is a randomised trial. The people taking part are put into treatment 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.  People in one group have peginterferon. People in the other group don’t.

You have peginterferon as an injection under the skin once a week. You or a family member can give the injections. Your doctor or nurse will show how to do it and give you an information leaflet on peginterferon and how to give it. If you don’t want to give the injections yourself, talk to your doctor and arrangements can be made to give it.

As long as the peginterferon is helping you and you don’t have any bad side effects, you can continue to have treatment for 2 years.

The trial team will ask you to fill out a questionnaire before you start treatment, at 3 months and 6 months then every 6 months for the next 2 years. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had surgery. They will also ask for some extra blood samples. They will use the samples to find out more about melanoma and how to treat it. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

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

During treatment you see the doctor every 3 months for a physical examination and blood tests. You have an ultrasound at 3 months and then every 6 months. You have a urine test and a CT scan or MRI scan every 6 months.

After treatment you see the doctor every 6 months up to 10 years. You have a physical examination and blood tests each time.

You also have

  • A CT scan or MRI scan every 6 months
  • An ultrasound scan after 3 years and then every year

Side effects

The most common side effects of peginterferon include

You doctor will tell you about all 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 Poulam Patel
Alessandro Testori

Supported by

Experimental Cancer Medicine Centre (ECMC)
European Organisation for Research and Treatment of Cancer (EORTC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11197

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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