Safety & Efficacy of Bevacizumab with Standard Glioblastoma Therapy

• Research type

  Research Study

• Full title

  A randomized, double blind, placebo controlled, multicenter Phase III trial of bevacizumab, temozolomide and radiotherapy, followed by bevacizumab and temozolomide versus placebo, temozolomide and radiotherapy followed by placebo and temozolomide in patients with newly diagnosed glioblastoma

• IRAS ID

  21469

• Sponsor organisation

  F. HOFFMAN-LA ROCHE LTD

• Eudract number

  2008-006146-26

• ISRCTN Number

  Not submitted

• Research summary

  Glioblastomas make up approximately 60-70% of malignant gliomas (most common type of brain tumour). They occur most frequently in adults in their mid 60s. The chance of developing a glioblastoma is less than 2 in 100,000 (0.00002%). However, the prognosis for this disease is poor, with only a third of patients surviving for a year and only 3% surviving for five years after diagnosis. Therefore there is a need for new therapies to help treat this aggressive disease.One of the reasons which makes glioblastoma so aggressive and therefore hard to effectively treat is that the tumour is very efficient at coordinating the growth of new blood vessels close to the tumour. Those surrounding blood vessels allow a constant supply of nutrients and oxygen for the tumour cells. One of the key factors involved in this blood vessel generation is the vascular endothelial growth factor (VEGF). Increased levels of VEGF have been detected in patients with glioblastoma. Previous studies have shown that the inhibition of VEGF may be beneficial in the treatment of newly diagnosed glioblastoma. The current treatment for newly diagnosed glioblastoma patients is to firstly reduce the size of the tumour/or completely remove it with surgery followed by a combination of radiation therapy and chemotherapy. The aim is to study whether adding a third component to the treatment, called bevacizumab, which prevents the effects of VEGF, would be significantly better than the current treatment alone. Bevacizumab is a monoclonal antibody (not a chemotherapy agent) used to specifically block the effects of VEGF. Currently, bevacizumab is being used in glioblastoma patients whose cancer has already relapsed. The safety and effectiveness of bevacizumab as a first line therapy is the question to be evaluated in this study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/87

• Date of REC Opinion

  1 Jul 2009

• REC opinion

  Further Information Favourable Opinion