A trial looking at ipilimumab and chemotherapy for small cell lung cancer (ICE)

This trial is looking into treating small cell lung cancer with a new drug called ipilimumab as well as with chemotherapy.

Doctors usually use chemotherapy to treat small cell lung cancer that has spread beyond the lungs (extensive disease). They often use the chemotherapy drugs carboplatin and etoposide. Sadly the cancer can start to grow again after chemotherapy. When this happens it is more difficult to treat.

In this trial researchers are looking at giving a drug called ipilimumab as well as chemotherapy.

Ipilimumab is type of biological therapy called a monoclonal antibody. Monoclonal antibodies target cancer cells by looking for particular proteins on the cells’ surface. Ipilimumab targets a protein called CTLA-4. Ipilimumab stops CTLA-4 from shutting down part of the immune system. So it may help the immune system to destroy cancer cells.

The aims of the trial are to

Find out if having ipilimumab as well as chemotherapy helps to delay or stop small cell lung cancer coming back
Learn more about the side effects
Find out more about how ipilimumab affects the immune system

Recruitment

Start 30/06/2011

End 30/06/2014

Phase

Phase 2

Who can enter

You may be able to enter this trial if you

Have extensive stage small cell lung cancer
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have not had any chemotherapy, or have just finished the 1st or 2nd cycle of carboplatin and etoposide chemotherapy
Have satisfactory blood test results
Are willing to use reliable contraception during the study and for 6 months 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 or central nervous system, is causing symptoms and needs treating
Have an autoimmune disease such as rheumatoid arthritis or Crohn’s disease - your doctor will discuss this with you
Have any medical condition that the trial team think would affect you taking part in this trial
Have had a live vaccine in the last 4 weeks
Have had any immunotherapy in the past, including ipilimumab
Take a high dose of steroids - it is important that you don’t stop taking steroids without talking to your doctor
Have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or superficial bladder cancer that was successfully treated at least 5 years ago
Are known to be HIV, Hepatitis B or Hepatitis C positive
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit about 40 people. Everybody taking part has chemotherapy and ipilimumab.

You have treatment through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. You have the treatment as an outpatient.

The chemotherapy is a combination of the drugs carboplatin and etoposide, which you have via a drip into a vein on day 1 of each treatment cycle. On days 2 and 3 of each cycle you take etoposide tablets at home.

You have 6 cycles of chemotherapy. In cycles 3, 4, 5 and 6 you will also have ipilimumab. You have ipilimumab through a drip into a vein.

You will be asked to fill out a questionnaire

Before you start treatment
On the first day of each cycle of treatment
When you finish treatment
6,12, 18 and 24 months after starting the study

The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

18 weeks after starting treatment doctors want to collect some of your white blood cells for research. They want to look at how your immune system has been affected by the treatment. These cells are collected during a procedure called leucapheresis. You have a drip in each of your arms that is attached to a machine. Your blood passes out of one drip, through the machine and back into your body through the other drip. The machine filters the white cells out of your blood. This will take about 3 hours.

You do not have to agree to give these cells if you don’t want to. You can still take part in the study.

If the treatment is helping you after 6 cycles of treatment, you may continue to have ipilimumab every 3 months until your cancer starts to grow again. This is called maintenance treatment.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests may include

Physical examination
Blood tests
Urine test
Heart trace (ECG)
Chest X-Ray
CT scan

On day 1 of each treatment cycle you will have

Physical examination
Blood tests
Urine test
Chest X-Ray

You will also see the doctors on the 8th day of cycles 1, 2 and 6 for blood and urine tests and a chest X-ray.

After 18 weeks, if you have agreed to have leukapheresis, then you go to hospital for up to 3 hours to have your white cells collected.

You will have CT scans and blood tests every 6 weeks for a year, and then every 3 months until your cancer starts to grow again.

If you continue to have ipilimumab 3 monthly after your 6 cycles of treatment, you will see the doctors every month to discuss any side effects you may be having.