A trial of anti-GD2 T-Cells for neuroblastoma that is not responding to treatment or has come back

 Neuroblastoma / Posted 1 year ago

This trial is looking at a new treatment using anti-GD2 T-cells. The researchers are taking immune cells from the blood and changing them so they can attack the cancer cells. Cancer Research UK is supporting this trial.

The aims of the trial are to find out:

  • if they can make anti-GD2 T-cells in the laboratory and if it is safe to give to people
  • about any side effects and the best way to treat them
  • whether giving chemotherapy first, improves how long the anti-GD2 T-cells survive and helps to increase their number
  • how well and for how long the anti-GD2 T-cells survive inside the body
  • whether anti-GD2 T-cells can shrink the neuroblastoma
  • Inclusion Criteria :
    • have neuroblastoma that has come back or neuroblastoma that isn’t responding to treatment
    • have neuroblastoma which can be assessed using a scan or a bone marrow test
    • are at least 1 year old. Babies between 6 to 12 months may be able to take part in a later stage of the trial
    • are well enough to take part. This means a Karnofsky or Lansky score of at least 60
    • have satisfactory blood test results
    • are willing to use reliable contraception during the trial and for 6 months afterwards if you are sexually active and there is any chance you or your partner could become pregnant. If you are female and have the drug cyclophosphamide or rituximab as part of the trial you must use effective contraception for 12 months after having these drugs
  • Exclusion Criteria :
    • have neuroblastoma that has spread to your brain and spinal cord (central nervous system). If you have had neuroblastoma in your central nervous system but have had it removed by surgery and there have been no signs of it coming back in the last 2 months you might be able to take part
    • have neuroblastoma that has spread to your airways or is pressing on your airways
    • have had anti-GD2 antibody treatment in the last 2 weeks. If you have had dinutuximab or other anti-GD2 directed treatment this may be longer, your doctor can advise you
    • are having experimental treatment as part of another clinical trial
    • have had major surgery and not yet recovered
    • have any side effects from previous treatment that are causing you problems
    • are allergic or sensitive to the drug rituximab or there is any other reason why you can’t have this drug
    • have an autoimmune disease and need to have treatment for this that affects your whole body (systemic treatment)
  • Study start date : 26/02/2016
  • Study end date : 25/02/2021
  • Wales-Based Study Contact : Not recruiting in Wales
  • Principal Investigator : Professor John Anderson

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