A trial of ipilimumab for children and teenagers who have melanoma that can't be removed with surgery (CA184178)

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

Cancer type:

Children's cancers
Melanoma
Skin cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at ipilimumab for children and young people who have melanoma that can’t be removed with surgery (advanced melanoma).

This trial is for children and teenagers between the ages of 12 and 18. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

More about this trial

If melanoma can’t be removed with surgery, you may have radiotherapychemotherapy or biological therapy, but researchers are looking for new treatments to help people in this situation. In this trial they are looking at a drug called ipilimumab.

Ipilimumab is a type of biological therapy. It helps the immune system to kill cancer cells.

Doctors already use ipilimumab to treat advanced melanoma in adults. The aims of this trial are to see

  • How well ipilimumab works in children and teenagers who have advanced melanoma
  • What the side effects are

Who can enter

You may be able to enter this trial if you

  • Have melanoma that has spread into lymph nodes or to another part of your body (stage 3 or 4 melanoma) and can’t be removed with surgery
  • Are at least 12 years old, but no older than 17
  • Are well enough to take part – this means that you need help to care for yourself, but not all the time (Karnofsky score of more than 50), or for younger children it means you get dressed and even if you don’t actively play, you take part in quiet play and activities (Lansky score of more than 50)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during the trial and for 3 months afterwards if you are sexually active and there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have melanoma that has spread to your brain unless, this is not causing symptoms and you haven’t needed to take steroids for at least 10 days
  • Have melanoma that started in your eye
  • Have already had a drug that works in a similar way to ipilimumab
  • Have had any other cancer treatment in the last 4 weeks – there may be exceptions to this (the trial team can advise you)
  • Take steroids or any other drugs that damp down your immune system
  • Have had any other cancer in the last 2 years apart from non melanoma skin cancer that was successfully treated
  • Have an autoimmune disease or have other problems with your immune system
  • Have an infection that can’t be controlled with medication
  • Have had your spleen removed or have had radiotherapy to your spleen
  • Have had a stem cell transplant using cells from a donor
  • Have had an allergic reaction to a drug made in a similar way to ipilimumab
  • Have any other medical condition or mental illness that the trial team think would make it unsafe for you to take part
  • Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit about 30 young people with melanoma. Everybody taking part will have 4 doses of ipilimumab. You have it through a drip into a vein once every 3 weeks. It takes about 1½ hours each time.

The trial team may suggest that you have the treatment once again if your melanoma initially gets smaller or disappears completely, but then starts getting worse (as long as this doesn't happen for at least 3 months).

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood tests
  • Heart trace (ECG)
  • CT scan, MRI scan or X-rays

You go to hospital once every 3 weeks to have the 4 doses of ipilimumab. At each visit, you have a physical examination and blood tests. You have a CT or MRI scan 2 weeks after your last dose of ipilimumab. And you may need to have a bone scan. You then have a CT or MRI scan every 3 months for 2 years and every 6 months after that.

When you finish having ipilimumab, you see the trial team again. A member of the trial team will then contact you by phone to see how you are. This will be every 3 months for 2 years and then every 6 months after that.

If you stop ipilimumab because you have bad side effects, the trial team will see how you are after 3, 4, and 6 months. They will then check how you are every 3 months for 2 years and every 6 months after that. This may be at hospital appointments, or by phone.

Side effects

The most common side effects of ipilimumab include

We have more information about ipilimumab.

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 Julia Chisholm

Supported by

Bristol-Myers Squibb
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10443

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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