Tests dendritic cell immune therapy against cancer stem cells in glioblastoma
Tests a cell-based immune therapy added to standard treatment in adults with glioblastoma.
Plain-language title generated from the registry record
Registry title: Study to evaluate the therapeutic effect of a cell based immune therapy targeting cancer stem cells i the malignant brain tumor glioblastoma.
Key facts
- Where
- Oslo, NorwaySee the site
- Phase
- Phase 2/3
Where in Norway
- Oslo University Hospital HFOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital HF
- Trial code
- NCT03548571EU 2024-518663-35-00
- Record updated
- 20 October 2026
- Original description
To identify the therapeutic effect of the product on progression free survival in glioblastoma patients.Read full original descriptionShow less
Open label randomized phase II/III trial of dendritic cell immunotherapy against cancer stem cells in glioblastoma patients receiving standard therapy (DEN-STEM)
To identify the therapeutic effect of the product on progression free survival in glioblastoma patients.
Inclusion: Must be at least 18 years and less than 70 years of age; Must be ambulatory with a ECOG performance status 0 or 1; Must have histologically confirmed glioblastoma IDH wild type, with non-methylated MGMT-gene promotor, and a candidate for combined radiation therapy and chemotherapy ("Stupps Regimen"); Must have accessible volume and quality of tumor tissue for vaccine production (proliferation of cells and extraction of tumor mRNA); Must have postoperative MRI after surgery with contrast enhancing tumor remnant of less than 1 cm3 or less than 10% of original tumor volume; Normal organ function defined by laboratory values; Serology indicating contagious HIV, HBV, HCV and Treponema pallidum must be negative; Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
Exclusion: Positive pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose. Reliable methods of contraception are defined in section; Prior splenectomy; Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions; Chemotherapy or other potentially immune-suppressive therapy outside protocol that has been administered within the last 4 weeks prior to vaccination; Tumor in a localization where a modest increase in size due to reactive edema may have a large impact on the patient's neurological condition, i.e. brain stem; History of prior malignancy other than glioblastoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB; Active infection requiring antibiotic therapy; Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia; Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure; History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome; Any reason why, in the opinion of the investigator, the patient should not participate.