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)
Conditions
Sponsors
Activartis Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: • Less than 100 µg of tumour protein obtained from the resected tissue for Tri-vax production. • Anti-neoplastic chemotherapy or radiotherapy at least 4 weeks before entering the study, e.g. in another therapeutic clinical trial. • Positive pregnancy test or breast-feeding. • Patients unwilling to perform a save method of birth control. • Known hypersensitivity to temozolomide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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). ;Primary end point(s): Progression free survival measured as percentage of non-progressive patients at 12 months post initiation of treat-ment. | — |
Countries
Austria
Outcome results
None listed