BO25041 Paed HGG

• Research type

  Research Study

• Full title

  A phase II open-label, randomized, multi-centre comparative study of bevacizumab-based therapy in paediatric patients with newly diagnosed supratentorial high-grade glioma.

• IRAS ID

  73862

• Contact name

  Darren Hargrave

• Sponsor organisation

  F. Hoffman-La Roche Ltd

• Eudract number

  2010-022189-28

• ISRCTN Number

  ISRCTN

• Research summary

  This study is being conducted by F. HOFFMANN-LA ROCHE LTD and is for paediatric patients from 3 to 17 years old who have recently been diagnosed with supratentorial high-grade glioma (non-brainstem HGG). The aim is to find out whether these patients improve when bevacizumab is added to their standard therapy (post-operative radiotherapy with temozolomide (TMZ)).Very few randomised trials, of any significant size, have been conducted in peadiatric patients with this disease.Despite advances in the treatment of these tumours in children, including combined chemotherapy, radiotherapy and surgery their prognosis remains poor. Bevacizumab, which inhibits the developement of blood supply, has shown to improve efficacy when administered with other chemotherapy in some cancers in adults, including colon, rectum, breast and lung: it is therefore important to assess the effectiveness of bevacizumab in childhood cancers that are difficult to treat. Bevacizumab use in this study is experimental.It is planned to recruit 120 patients =3 and < 18 years of age with newly diagnosed localised supratentorial non-brainstem HGG over a period of 36 months with a recruitment period of approx 3 years, it is estimated that the study duration will be 6 years. Patients will receive either Chemo-radiation and TMZ alone (ARM A) or Chemo-radiation,Bevacizumab and TMZ (Arm B) The main objective of this trial is to evaluate the efficacy, safety, tolerability, of bevacizumab when added to standard postoperative radiotherapy with concomitant and adjuvant TMZ and to determine whether the addition of anti-angiogenic therapy with bevacizumab in the management of children with newly diagnosed supratentorial HGG is of clinical benefit.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/0923

• Date of REC Opinion

  5 Jul 2011

• REC opinion

  Favourable Opinion