Brain tumour clinical trial title

VINILO – A trial of vinblastine and nilotinib for children and young people with a brain tumour (Study ID: 31853)

Brain tumour type




Low grade gliomas (LGG) are the most frequent brain tumour in children. More than 50% of these tumours will progress within the first 5 years and need further treatment. As most patients are young, the risks of radiotherapy to the developing brain are high, further medical treatment options are urgently needed. Vinblastine is an effective chemotherapy drug for LGG and has been shown to improve survival. Nilotinib is type of biological therapy called a tyrosine kinase inhibitor. Vinblastine and Nilotinib have different antiangiogenic mechanisms, limited and non-overlapping toxicities, and are thought to play an interesting role in the treatment of paediatric LGG. The phase I part of the trial has already been completed and identified the recommended doses (RD) of each agent when given in combination. The main objective of the phase II part is to evaluate the efficacy of vinblastine in combination with nilotinib at the RD, as compared to vinblastine alone, in children, adolescents, and young adults with refractory or recurrent LGG. This is an open label, randomised, study of the combination of nilotinib and vinblastine versus vinblastine alone 122 patients with LGG will be randomised to receive either: • Vinblastine and nilotinib OR • Vinblastine only Vinblastine will be given as an intravenous injection on days 1, 8, 15 and 22 of each 28 day cycle. Nilotinib will be taken as a capsule orally twice a day on each day of the cycle. Patients will receive up to 12 cycles of treatment in the trial as long as they are benefitting from it and are well. This trial is being funded in the UK by Cancer Research UK (including funding from the Brain Tumour Charity). Nilotinib is being provided free of charge by Novartis. This trial will open at 6 sites in the UK plus others within Europe. The Sponsor of this international study is Gustave Roussy, France.

Date added: 11th January 2019

Open/Closed: Open

Trial ends: December 2019


University of Birmingham

Contact details

Bridget Shaw :

B15 2TT

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