Glioblastoma Multiforme Clinical Trial
Official title:
An Open-labelled, Randomized Phase II Study to Investigate Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells (ALECSAT) in Patients With GBM Measured as Progression Free Survival Compared to Avastin/Irinotecan
The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to standard Bevacizumab/Irinotecan second line treatments for these patients.
This study is an open-label, randomized, prospective, parallel group phase II study with
ALECSAT compared to Bevacizumab/Irinotecan in patients with verified relapsed glioblastoma
multiforme after or during treatment with recognised first-line treatment. After 62 PFS
events have been recorded, an interim analysis will be conducted under the auspices of the
Data Monitoring Committee.
The patients in the two treatment groups will be followed for up to 62 weeks by planned
study visits. Patients with, at least, stable disease will continue the allocated treatment
after the study period as judged by the Investigator. Patients allocated to the
Bevacizumab/Irinotecan (control group) will receive their treatment according to standard
praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle of
Bevacizumab/Irinotecan consist of 2 dosing days; day 1 and day 15 in the cycle.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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