Ignite Creation Date:
2024-05-06 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03548571
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2018-04-30
Brief Title:
Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Open Label Randomized Phase IIIII Trial of Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy DEN-STEM
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEN-STEM
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None