DC Vax-Brain Phase III trial for GBM- Current

• Research type

  Research Study

• Full title

  Protocol 020221: A Phase III Clinical Trial Evaluating DCVax®-L Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme

• IRAS ID

  131576

• Contact name

  Keyoumars Ashkan

• Contact email

  k.ashkan@nhs.net

• Sponsor organisation

  Northwest Biotherapeutics Inc

• Eudract number

  2011-001977-13

• Clinicaltrials.gov Identifier

  NCT00045968

• Duration of Study in the UK

  4 years, 6 months, 31 days

• Research summary

  The purpose of the study is to determine the safety and efficacy of an investigational therapy called DCVax(R)-Brain in patients with newly diagnosed GBM for whom surgery is indicated. Patient must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive standard of care, including radiation and chemotherapy (including temozolomide) and two out of three will additionally receive DCVax-Brain and the remaining one third will receive placebo. Patients randomized to placebo will have the option to receive DCVax-Brain in a crossover arm upon documented disease progression.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/0957

• Date of REC Opinion

  5 Oct 2011

• REC opinion

  Further Information Favourable Opinion