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Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy — DEN-STEM  

Glioblastoma Clinical Trial

Official title:
Open Label Randomized Phase II/III Trial of Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy (DEN-STEM)

Clinical Trial Summary

Open, randomized study of a trivalent dendritic cell therapy compared to standard therapy in primary treated patients with IDH wild-type, MGMT-promotor methylated glioblastoma. The IMP is dendritic cells transfected with mRNA of survivin, hTERT og autologous tumor stem cells derived from tumorspheres.

Clinical Trial Description

Autologous leukapheresis for enrichment of PBMCs is performed after enrollment of the patient into the trial. Ex vivo generated DCs will be frozen and stored in the vapour phase of liquid nitrogen. At first surgery, tumor biopsies will be cultured under sphere-forming conditions under ex vivo conditions for enrichment of glioblastoma stem cells. mRNA will purified and amplified from these autologous tumor stem cells. At specified intervals patients randomized to the vaccine group will receive intradermal injections of DCs transfected with mRNA from autologous tumor stem cells, survivin and hTERT. Injections will be given as three separate injections at three separate sites. Vaccination will be continued for as long as there are vaccines available. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03548571
Study type Interventional
Source Oslo University Hospital
Contact Einar O Vik-Mo, MD, PhD
Phone +47 23074340
Email uxvieb@ous-hf.no
Status Recruiting
Phase Phase 2/Phase 3
Start date April 26, 2018
Completion date May 1, 2026
View Details
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