First line standard therapy of glioblastoma multiforme with or without add-on treatment with Trivax, an anti-tumour immune therapy based on tumour-lysate charged dendritic cells

INTERVENTION: Product Name: Trivax Pharmaceutical Form: Suspension for injection CONDITION: Patients older than 3 years of age with newly diagnosed Glioblastoma Multiforme (GBM) undergoing brain surgery for removal of at least 70% of tumour mass and receiving subsequently standard radiation therapy and standard chemotherapy with temozolomide. ; MedDRA version: 14.1 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) PRIMARY OUTCOME: Main Objective: Progression free survival measured as percentage of non‐progressive patients with newly diagnosed GBM 12 months after a post‐operative MRI scan treated according to the current standard (surgical resection, irradiation, oral chemo‐therapy with Temozolomide), and Trivax, an autologous DC cancer vaccine charged with autologous tumour protein, as add‐on therapy (group A), in comparison to patients receiving standard treatment without Trivax (group B). Primary end point(s): Progression free survival measured as percentage of non‐progressive patients at 12 months post initiation of treat‐ment. Secondary Objective: Progression free survival measured as percentage of non‐progressive patients with newly diagnosed GBM 18 and 24 months after a post‐operative MRI scan receiving standard treatment and Trivax as add‐on therapy (group A), in com‐parison to patients receiving standard treatment without Trivax (group B).; ; Extension of overall survival of patients with newly diagnosed GBM receiving standard treatment and Trivax as add‐on therapy, in comparison to patients receiving standard treatment without Trivax. ; ; Quality of life in patients treated with Trivax as an add‐on therapy using ECOG (Eastern Cooperative Oncology Group) performance status compared to quality of life of patients receiving standard therapy (for study patients older 18 years).; INCLUSION CRITERIA: • Female or male, paediatric or adult patients older than 3 years of age at time of diagnosis that qualify for standard treatment including surgery, Temozolomide and radiotherapy. • Primary GBM (WHO IV), confirmed by histology. • Resection of at least 70% of tumour mass defined by brain MRI scan. • Supratentorial tumour localisation. • Life expectancy of at least 12 weeks by assessment of the attending physician. • ECOG performance status 0, 1, or 2 (for study patients older 18 years). • Written informed consent of patient and/or legal guardian in case of children and adolescents. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range