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NCT03548571RecruitingPhase 2/3

Study to evaluate the therapeutic effect of a cell based immune therapy targeting cancer stem cells i the malignant brain tumor glioblastoma.

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Oct 2026

Brief summary (registry, in English)

To identify the therapeutic effect of the product on progression free survival in glioblastoma patients.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
60 (estimated)
First submitted
12 Oct 2024
Start date
25 Apr 2018
Lead sponsor
Oslo University Hospital HF
Diseases
Glioblastoma
NCT number
NCT03548571
EU CT number
2024-518663-35-00
EudraCT number
2015-002198-40

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 60
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • Any reason why, in the opinion of the investigator, the patient should not participate.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Oslo University Hospital HF
Coordinator of this site? Confirm its status
OsloNorwayRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.