Biomede

 Diffuse intrinsic pontine glioma / Posted 1 year ago

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication(Biomede)

Biomede is an international, multicenter, randomised, open-label, adaptive, phase II trial of treatment for Diffuse Intrinsic Pontine Glioma (DIPG). This trial mandates a biopsy of the tumour to obtain the biological profile of the tumour. The allocation of treatment in each patient will be based on the specific biological tumour profile. Recruitment target is 80 patients in the UK, 250 in the EU with DIPG over 4 years. The initial agents to be studied based on biomarkers profile are; Dasatinib, Erlotinib and Everolimus as single agents combined with standard radiotherapy.

  • Inclusion Criteria :
    • Have diffuse intrinsic pontine glioma
    • Are able to have a sample of tissue (biopsy) of your tumour taken unless a sample is available from a biopsy done when you were diagnosed
    • Are able to have radiotherapy to the brain
    • Have satisfactory blood test results
    • Need quite a lot of help to care for yourself (Karnofsky performance scale 50 or more) or you get dressed but need to lie down for much of the day and only take part in quiet play and activities (Lansky play scale 50 or more)
    • Are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
    • Are aged between 6 months old and 30 years old
  • Exclusion Criteria :
    • You have a type of brain tumour called pilocytic astrocytoma or ganglioma
    • You have had a major bleed within your tumour
    • You are having other cancer treatments
    • You have had radiotherapy to the brain stem for another cancer
    • You have had another type of cancer in the past 5 years
    • You have moderate to severe problems affecting other body organs such as the heart, kidneys, liver or lungs
    • You have a medical condition called congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption – your doctor can tell you this
    • You have another medical or mental health condition that the trial team think could affect you taking part
    • You are pregnant or breastfeeding
  • Study start date : 14/04/2017
  • Study end date : 01/04/2021
  • Wales-Based Study Contact : Not recruiting in Wales
  • Principal Investigator : Dr Darren Hargrave

No post found