A trial of dacarbazine and ipilimumab for stage 3 or 4 melanoma (CA184024)

Please note this trial is no longer recruiting patients.

This trial is looking at dacarbazine and ipilimumab for stage 3 or 4 melanoma.

Doctors sometimes use chemotherapy to treat melanoma. You may have chemotherapy if melanoma has come back after having other treatment, or if melanoma cannot be removed by surgery when it is first diagnosed.

Treating melanoma with chemotherapy is still experimental. A drug called dacarbazine has been tested more than any other. It has had some success in controlling melanoma.

Ipilimumab is a type of biological therapy called a monoclonal antibody (MAB). Researchers think that giving ipilimumab as well as chemotherapy may be better than chemotherapy alone. But they don’t know for sure. All treatments have side effects, and it is important that people don’t have treatment they don’t need.

The aims of this trial are to

Find out if dacarbazine and ipilimumab together work better than dacarbazine alone
Learn more about the side effects

Recruitment

Start 07/02/2007

End 03/03/2008

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with stage 3 melanoma that cannot be removed surgically and hasn’t yet been treated or you have been diagnosed with stage 4 melanoma
Are well enough to take part
Have satisfactory blood test results
Are prepared to use a reliable form of contraception while you are taking part in the trial (and for 8 weeks afterwards) if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread to your brain
Have melanoma of the eye or mucosal melanoma (this is a rare type of melanoma that usually starts in the head and neck area)
Have had any other type of cancer, apart from non melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix that have been successfully treated, or another cancer that has been in complete remission for at least 5 years
Have any sort of auto immune disease
Have had chemotherapy, radiotherapy or surgery for stage 3 or 4 melanoma - you can take part if you had treatment in the past for melanoma that has now come back
Are taking steroids (please note, it is important that you do not stop taking steroids unless your doctor tells you to)
Have had a vaccine to prevent an infectious disease in the last 4 weeks
Have taken part in any other trial of ipilimumab
Have had treatment with a similar type of monoclonal antibody
Have had another experimental treatment as part of a clinical trial in the last 4 weeks
Have any other medical condition which would make it unsafe for you to take part in this trial
Are known to be HIV, Hepatitis B or Hepatitis C positive
Are pregnant or breastfeeding

Trial design

This is an international trial that will recruit about 500 patients altogether. 30 to 35 of those people will be in the UK. It is a randomised trial. You will be put into one of 2 treatment groups by a computer. Neither you, nor your doctor will be able to decide which group you go in. You will not know which group you are in, as both groups will have treatment that looks the same. This is called a ‘blind’ trial.

Everybody taking part will have dacarbazine once every 3 weeks. Each 3 week period is known as a cycle of treatment. You will have 8 cycles in all (24 weeks treatment in total). You will have the dacarbazine as a drip into your bloodstream (an intravenous infusion). This will take 30 to 60 minutes each time.

If you are in group 1 you will have ipilimumab before your first 4 chemotherapy treatments. You will have this as a drip into the bloodstream which will take 90 minutes.

If you are in group 2, you will have a placebo before your first 4 chemotherapy treatments. This will also be a drip lasting 90 minutes.

If your doctors think that the treatment is helping you and there is no sign of the cancer growing between week 12 and week 24, they may ask you to carry on having ipilimumab or placebo after the 24 weeks. This is called the maintenance phase of the trial.

During the maintenance phase of the trial, you will not have any more dacarbazine. You will have ipilimumab or placebo every 12 weeks. You may continue to receive the treatment for as long as it helps you.

Your doctors will ask you to fill in questionnaires after the first 3 treatments, in the middle of your treatment course and at the end. These will ask you about how you are feeling. This is called a quality of life study. If you carry on having maintenance treatment, you will also fill in questionnaires after your first 2 maintenance treatments.

Hospital visits

You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include

Physical examination
CT scan
MRI scan
Bone scan
Photographs of melanoma that can be seen on your skin

You will have blood tests before each cycle of treatment. You will have other blood tests in the middle and at the end of your treatment course, to see how well treatment is working.

You will have 4 CT or MRI scans during the treatment - one in the middle of the course and one at the end, with 2 more in between.

If you carry on into the maintenance phase of the trial, you will go to see the trial doctors every 6 weeks for the next 24 weeks and every 12 weeks after that. At these visits you will have a CT or MRI scan and more photographs taken of your melanoma. You will have blood tests every 12 weeks.

After you finish treatment, you will go and see the trial doctors once more about 2 months later. At this visit you will have some blood tests. After that, the trial doctors will phone you every 3 months to see how you are.

Side effects

Ipilimumab is a new and experimental treatment, so there may be some side effects that doctors don’t know about yet. From earlier trials, doctors know that the possible side effects include