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

Activartis Biotech GmbH0 个研究点目标入组 76 人开始时间: 2009年12月22日最近更新: 2015年10月12日

适应症

试验速览

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•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

•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.

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