Dendritic cell therapy for glioblastoma patients
Open Label Randomized Phase II/III Trial of Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy (DEN-STEM)
This study is testing a new treatment using patients' own immune cells to see if it can help fight glioblastoma while they continue their regular cancer treatments.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Oslo) |
| Trial ID | NCT03548571 on ClinicalTrials.gov |
What this trial studies
This open, randomized study evaluates a trivalent dendritic cell therapy in glioblastoma patients who are receiving standard treatment. Patients will undergo leukapheresis to enrich their peripheral blood mononuclear cells, which will then be used to create dendritic cells transfected with mRNA from their own tumor stem cells. These dendritic cells will be administered through intradermal injections at specified intervals, while patients continue to receive standard chemotherapy and radiation. The goal is to enhance the immune response against cancer stem cells in glioblastoma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed IDH wild-type glioblastoma and accessible tumor tissue for vaccine production.
Not a fit: Patients with glioblastoma who do not meet the eligibility criteria, such as those with unmethylated MGMT-promoter or significant tumor remnants, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could improve survival rates and outcomes for glioblastoma patients by targeting cancer stem cells more effectively.
How similar studies have performed: While dendritic cell therapies have shown promise in other cancers, this specific approach targeting glioblastoma stem cells is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
All of the following conditions must apply:
* 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 unmethylated 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) at first surgery.
* 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 as following: ANC \> 1.5 x 109/L; platelets \>100 x109/L, Hb \>9g/dL (\> 5.6 mmol/L). Creatinine \< 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance \>40 mL/min, Bilirubin \< 20% above the upper limit of normal, ASAT and ALAT \< 2.5 the upper limit of normal. Albumin \>2.5 g/L.
* 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 Criteria:
* Tumor in a localization where a modest increase in size due to reactive oedema 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.
* Prior splenectomy.
* Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.
* Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
* 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.
* Chemotherapy or other potentially immune-suppressive therapy outside protocol that has been administered within the last 4 weeks prior to vaccination.
* 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 .
* Any reason why, in the opinion of the investigator, the patient should not participate.
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Iver A Langmoen, MD, PhD — Oslo University Hospital
- Study coordinator: Einar O Vik-Mo, MD, PhD
- Email: uxvieb@ous-hf.no
- Phone: +47 23074340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.