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 - GBM-Vax

Conditions: 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: 14.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2009-015979-27-AT

Lead Sponsor: Activartis Biotech GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 76

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

•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.