
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is for adults and young people from the age of 13 with Ewing’s sarcoma that has come back after treatment.
Cancer Research UK supports this trial.
Ewing’s sarcoma is a type of cancer that usually starts in the bones. It is more common in children and young adults.
Chemotherapy is often used to treat Ewing’s sarcoma. But sometimes it can continue to grow or come back after treatment. When this happens, there aren’t many other treatments that doctors can use. So they are looking for new ways to help people in this situation.
Niraparib is a new drug. It is a type of biological therapy called a PARP inhibitor. This means it blocks an called PARP, which helps damaged cells to repair themselves.
Temozolomide (Temodal) and irinotecan (Campto) are chemotherapy drugs. Both work by stopping cancer cells from dividing into 2 new cells. So the cancer can’t grow.
Temozolomide and irinotecan are common treatments for people with Ewing’s sarcoma that has come back. But this is the first time that niraparib will be given to people with Ewing’s sarcoma.
The main aims of this trial are to:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply:
You cannot join this trial if any of these apply.
Cancer related
Medical conditions
Other
This is an international phase 1 trial. Researchers hope between 30 to 50 people will take part.
This trial has 2 parts. The UK will only take part in arm B:
Niraparib and irinotecan
You take niraparib capsules from day 1 to 7 of each treatment cycle. The first few people taking part have a low dose of niraparib. If they don’t have any serious side effects, the next few people have a higher dose.
You have irinotecan as a drip into your vein. You have it from day 2 to 6 of each treatment cycle. It takes about 60 minutes each time. The dose of irinotecan you have might increase as doctors want to find the highest safest dose that can be given together with niraparib.
You continue having this treatment for as long as it helps you and the side effects aren’t too bad.
Blood tests
Everyone taking part in this trial has extra blood tests. You have the extra tests before the start of treatment and after you finish.
Doctors want to learn how the treatment works and find out your risk of developing:
You have this test because there is a very small risk of you developing MDS or AML during the treatment. If your doctor thinks that you have developed this, you will have a to confirm it.
The trial team will ask you to store some of your blood samples. You must agree to have your samples stored if you want to take part in this trial. Your details will be removed from the samples so no one can identify you.
Tissue sample
Before the start of treatment you might need to have a tissue sample of your cancer taken. This is only if your doctor thinks it’s safe for you to have it.
You might also have an extra biopsy during your treatment if you are older than 18. You don’t need to agree to this if you are younger than that. You can still take part.
Your doctor will also ask to use a sample of cancer taken when you were first diagnosed (an archived tumour tissue).
Diary
The trial team will ask you to keep a diary to record:
This helps your doctor to understand how many doses of treatment you had.
You see a doctor and have some tests before taking part. These tests might include:
After you start treatment, you see a doctor every week for the first 2 months. You also have blood tests every 3 to 4 days.
After 2 months you see the doctor every other week and have blood tests every week. This continues of 2 months. You then see the doctor every month and have blood tests every other week.
You have a CT and an MRI scan every 8 weeks while you are having treatment. This continues for as long as your cancer stays the same and does not get worse. If your cancer gets worse you stop having treatment.
When you finish your treatment you see the doctor and have blood tests. You also have a CT and an MRI scan. You continue to see the doctor until all the side effects from the treatment stop.
The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
The most common side effects of niraparib are:
We have information on:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Sandra Strauss
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Sarcoma Alliance for Research through Collaboration (SARC)
This is Cancer Research UK trial number CRUKDE/14/021
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”