BEACON-Neuroblastoma Trial: Bevacizumab, Temozolomide ± Irinotecan

• Research type

  Research Study

• Full title

  A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma – BEACON-Neuroblastoma Trial

• IRAS ID

  90924

• Contact name

  Andrew Pearson

• Eudract number

  2012-000072-42

• ISRCTN Number

  n/a

• Research summary

  Patients aged 1-21 years will be eligible to participate in this trial if they have been diagnosed with Neuroblastoma where their disease has reoccurred (relapsed) or is not responding to other forms of treatment (refractory). Patients must also have a life expectancy of at least 12 weeks and meet other specific entry criteria.Children with relapsed/refractory high risk Neuroblastoma have poor prognosis. There is currently no agreed way of treating these patients and many different chemotherapy combinations are used. Temozolomide alone and in combination with Irinotecan are common regimes, yet trials to date have provided no evidence that Irinotecan aids the activity of Temozolomide. This study aims to test whether Temozolomide alone or in combination with Irinotecan is better at treating Neuroblastoma.There is an unmet need to try out new agents in Neuroblastoma. Bevacizumab is a monoclonal antibody against Vascular Endothelial Growth Factor (VEGF). VEGF stimulates the production of new blood vessels (angiogenesis). By blocking the growth of new blood vessels and starving the tumour of oxygen, bevacizumab restricts tumour growth. Adult studies have established the safety profile of the drug with manageable toxicity (side effects), in addition to showing a survival advantage. Paediatric evaluation has shown no severe unexpected toxicities. This trial will evaluate the activity of bevacizumab in addition to chemotherapy in patients with relapsed/refractory Neuroblastoma.Patients will be recruited from hospitals experienced in running early phase trials throughout Europe. 120 patients aged 1-21 years with relapsed/refractory Neuroblastoma will be randomised to receive therapy in 1 of 4 arms:Arm BT: Bevacizumab and Temozolomide Arm IT: Irinotecan and Temozolomide Arm BIT: Bevacizumab, Irinotecan and Temozolomide Arm T: Temozolomide Response will be assessed after the second, fourth and final cycle of treatment. Patients may receive up to 6 cycles of therapy in the absence of disease progression.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  13/WM/0023

• Date of REC Opinion

  6 Feb 2013

• REC opinion

  Favourable Opinion