Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy
NCT03548571 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-04-03
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.
Conditions
Interventions
- BIOLOGICAL
-
Dendritic cell immunization
Intradermal injection
- DRUG
-
Adjuvant temozolomide
After a 4-week break, patients were then to receive up to six cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days at 150 mg per square meter for the first cycle and thereafter increase to 200 mg per square meter beginning with the second cycle.
Sponsors & Collaborators
-
Oslo University Hospital
lead OTHER
Principal Investigators
-
Iver A Langmoen, MD, PhD · Oslo University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-26
- Primary Completion
- 2025-12-01
- Completion
- 2026-05-01
Countries
- Norway
Study Locations
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