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Open label randomized phase II/III trial of dendritic cell immunotherapy against cancer stem cells in glioblastoma patients receiving standard therapy (DEN-STEM)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518663-35-00
Acronym
DEN-STEM
Enrollment
60
Registered
2024-10-30
Start date
2018-04-25
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Brief summary

Progression free survival - Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria. Assessment of objective tumor response includes an evaluation by MRI at the start of vaccination, at week 25 and thereafter every 3 months., As contrast enhancement may vary over time, due to pseudoprogression and may be affected through the course of the immune-therapy, the definite time of progression may be corrected after overall survival has been reached.

Interventions

DRUGAutologous cancer stem cell mRNA transfected dendritic cells

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression free survival - Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria. Assessment of objective tumor response includes an evaluation by MRI at the start of vaccination, at week 25 and thereafter every 3 months., As contrast enhancement may vary over time, due to pseudoprogression and may be affected through the course of the immune-therapy, the definite time of progression may be corrected after overall survival has been reached.

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026