RecruitingPhase 2Phase 3NCT03548571

Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy

Open Label Randomized Phase II/III Trial of Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy (DEN-STEM)

Sponsor

Oslo University Hospital

Enrollment

60 participants

Start Date

Apr 26, 2018

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a personalized vaccine made from a patient's own brain tumor cells to help the immune system fight glioblastoma (a fast-growing, aggressive brain tumor), given alongside the standard chemotherapy and radiation treatment. **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with glioblastoma (a specific type: IDH wild-type with unmethylated MGMT promoter) - You are ambulatory and in generally good health (able to carry out normal daily activities) - Your surgeon was able to remove most of the tumor, leaving very little behind - Your blood counts, kidney, and liver function are within healthy ranges - You tested negative for HIV, hepatitis B, hepatitis C, and syphilis **You may NOT be eligible if...** - You have a different type of brain tumor - Your surgery left a large amount of tumor behind - Your organ function (kidneys, liver, blood counts) is not adequate - You are unwilling or unable to provide written consent and follow the treatment schedule - You have an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDendritic cell immunization

Intradermal injection

DRUGAdjuvant 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.