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Clinical Trial Summary

The primary objective of the study is to determine whether overall survival of newly diagnosed glioblastoma patients treated with lysate-loaded, mature dendritic cell vaccines as add-on to the standard of care consisting of resection, radiotherapy with concomitant temozolomide chemotherapy and subsequent adjuvant temozolomide chemotherapy is superior to the treatment with the standard of care alone.


Clinical Trial Description

This is a multicenter, randomized, phase 2 study, integrating vaccination with tumorlysate-loaded mature dendritic cells into standard radio/temozolomide-chemotherapy of newly diagnosed glioblastoma patients with near-complete resection after fluorescence-guided resection. Only patients with confirmed gross-total resection and a residual tumor volume below 5 ml will be eligible for the trial. Vaccination will be performed after radio- and concomitant temozolomide chemotherapy and during the first three cycles of adjuvant TMZ. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03395587
Study type Interventional
Source Heinrich-Heine University, Duesseldorf
Contact Michael Sabel, Prof. MD
Phone +49 211 8116276
Email Michael.Sabel@med.uni-duesseldorf.de
Status Recruiting
Phase Phase 2
Start date March 6, 2018
Completion date March 6, 2027

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