A trial of dabrafenib and trametinib for children and young people with a glioma

 Diffuse intrinsic pontine glioma / Posted 2 years ago

Some gliomas have a change (mutation ) in the BRAF gene called BRAF V600. The BRAF gene makes a protein that affects how cancers grow and divide.

Dabrafenib and trametinib are targeted drugs. They work by blocking the action of the BRAF protein so possibly stopping the cancer growing or spreading.

We know that the combination of dabrafenib and trametinib works for other cancers that have the BRAF V600 change. Researchers think it could help children and young people whose glioma has the BRAF V600 change.

In this trial everyone who has a fast growing glioma will have dabrafenib and trametinib.

Everyone who has a slow growing glioma will have either:
dabrafenib and trametinib or
carboplatin and vincristine (standard treatment )
The aims of this trial are to find:
how well dabrafenib and trametinib works for children and young people with a glioma
how dabrafenib and trametinib works in the body of children and young people
out about the side effects of having dabrafenib and trametinib together
out how tasty and acceptable liquid dabrafenib and liquid trametinib is

  • Inclusion Criteria :
    • have a low grade glioma that has got worse following surgery or can’t be removed by surgery and needs treatment or you have a high grade glioma that got worse during treatment or came back after treatment
    • have a glioma with a change (mutation ) in the BRAF V600 gene
    • have a glioma that can be measured on a scan might need quite a lot of help to look after yourself (Karnofsky performance status 50 or more) or you can get dressed, lie down for most of the day and take part in quiet play (Lansky performance status 50 or more) have satisfactory blood test results
    • are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant are at least 12 months old and haven’t yet had your 18th birthday
  • Exclusion Criteria :
    • have another cancer
    • have already had dabrafenib, trametinib or any other drug that works in a similar way
    • have had another cancer treatment within 3 weeks of starting treatment, if you are taking steroids you must be taking a stable dose or a reducing dose a week before starting treatment
    • have had radiotherapy to the glioma within 3 months unless a scan shows that the glioma has continued to grow
    • have had an experimental drug as part of a clinical trial within 3 weeks of starting treatment
    • have had another cancer that had a gene change (mutation) in the RAS gene or a combination of genes that included the BRAF gene
    • have ongoing moderate to severe side effects from any previous cancer treatment
    • have had a stem cell transplant within 3 months of starting treatment
    • have had graft versus host disease (GVHD)
  • Study start date : 14/06/2018
  • Study end date : 05/11/2020
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr Darren Hargrave

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