Ipi-Glio

 Glioblastoma / Posted 1 year ago

A trial of ipilimumab and temozolomide for people with glioblastoma

Glioblastoma is one of the most common types of brain tumours in adults. The usual treatment for people with a newly diagnosed glioblastoma is: surgery to remove some or all of the tumour
then 6 weeks of radiotherapy with temozolomide (this is called chemoradiotherapy) then temozolomide alone for up to 6 months (this is the adjuvant treatment)

But glioblastomas can come back or continue to grow despite the usual treatment. In this trial, doctors want to find out whether ipilimumab can help to stop glioblastomas from coming back.

Ipilimumab (also called by its brand name Yervoy) is a type of targeted drug called a monoclonal antibody. It works by stimulating certain immune cells called T-cells to find and attack the cancer. Ipilimumab is already a possible treatment for people with advanced melanoma.

Everyone taking part in this trial has surgery and 6 weeks of chemoradiotherapy. They then have one of the following adjuvant treatments:
temozolomide (the usual treatment)
temozolomide and ipilimumab
The main aim of this trial is to find out whether adding ipilimumab to the usual treatment helps people with glioblastoma.

  • Inclusion Criteria :
    • you have a newly diagnosed glioblastoma
    • you had brain surgery and doctors removed at least a fifth of the tumour (your doctor can tell you more about this)
    • you started radiotherapy within 49 days (about 1 and 1/2 months) after surgery
    • have completed 6 weeks of radiotherapy and temozolomide (chemoradiotherapy)
    • doctors think that temozolomide is a suitable treatment for you
    • you are between 18 and 70 years old
    • you have satisfactory blood test results
    • you are well enough to carry out all your normal activities apart from heavy physical work (performance status 0 or 1)
    • you are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any possibility that you or your partner could become pregnant
  • Exclusion Criteria :
    • you have a type of glioblastoma called multifocal (your doctor can tell you more about this)
    • you had a low grade astrocytoma that turned into a glioblastoma (a secondary glioblastoma)
    • your glioblastoma has spread outside the brain or to the membranes that cover the brain (carcinomatous meningitis)
    • you have had any treatment apart from surgery and 6 weeks of radiotherapy with temozolomide (chemoradiotherapy)
    • you take a high dose of dexamethasone (more than 3mg every day)
    • you have a significant bleeding in or around the glioblastoma
    • you have had another active cancer apart from non melanoma skin cancer or an early cancer (carcinoma in situ) of the cervix that has been successfully treated have an autoimmune disease that doctors think could affect you taking part in this trial have lung problems such as scarring of the lungs (fibrosis) take, or have taken drugs that damp down your immune system unless it was a cream, inhaler or a very small dose have problems with your digestive system that doctors think could affect you taking part in this trial had a severe infection in the past month are taking part in another clinical trial or have taken part in a trial in the past 4 weeks that looked at a new treatment (interventional trial) have HIV have hepatitis B or hepatitis C have any other serious condition or mental health problem that the trial team think could affect you taking part
  • Study start date : 21/12/2018
  • Study end date : 21/06/2021
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr Paul Mulholland

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