A trial looking at niraparib with temozolomide or irinotecan for Ewing’s sarcoma that has come back (ESPRIT)

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 have Ewing’s sarcoma that has continued to grow or came back after treatment  
• You are willing to have a sample of tissue taken (a biopsy ) from your sarcoma before starting treatment 
• If you are older than 18 you must be willing to have an additional biopsy during treatment (this is optional if you are under 18 years old)
• You have at least 1 area of sarcoma that can be seen on a scan and measures at least 10 mm
• You have had a minimum of 1 treatment combination (treatment regimen) with at least 2 of the following drugs – doxorubicin, cyclophosphamide, ifosfamide or etoposide
• You have satisfactory blood test results 
• Your heart is working well
• You are able to swallow capsules
• You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)  
• You are at least 13 years old 
• You are willing to use reliable contraception during the trial and for 6 months after the last treatment if there is any chance you or your partner could become pregnant  

You cannot join this trial if any of these apply. 

Cancer related

• You have had any anti cancer treatment that reached your whole body (systemic treatment) in the last 3 weeks
• You have had radiotherapy or major surgery in the last 2 weeks
• You have severe side effects from previous cancer treatment or from a stem cell transplant  using your own cells (autologous)
• If you have had a stem cell transplant using cells from a donor (an allogenic transplant) you must have had this more than 6 months ago and you must have no signs of graft versus host disease and you can’t have taken any drugs used to damp down your immune system (immunosuppressants) in the past 30 days
• Your sarcoma has spread to your brain or spinal cord (central nervous system) and is causing symptoms. You might be able to take part if you have had surgery or radiotherapy to the areas of spread more than 6 weeks ago, have recovered from any side effects and haven’t taken steroids for at least a month 
• You are having other anti cancer treatments or experimental treatments 
• You have had another cancer in the last 5 years apart from basal cell cancers (BCC), squamous cell skin cancers and a pre cancer of the cervix (cervical intraepithelial neoplasia) 
•  You have had a low count of platelets, white cells and red cells for more than 4 weeks as a result of previous cancer treatment

Medical conditions

• You are known to be sensitive to niraparib, temozolomide, irinotecan or similar drugs
• Your bone marrow  doesn’t make enough healthy cells (myelodysplastic syndrome)
•  You have another medical condition that the trial team think could affect you taking part 

Other

• You are pregnant or breastfeeding