Study on the Effects of Dendritic Cell Immunotherapy and Temozolomide in Patients with Glioblastoma

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What is this study about?

This clinical trial is focused on studying a type of brain cancer known as glioblastoma. The treatment being tested is a new form of cell-based immune therapy called Autologous cancer stem cell mRNA transfected dendritic cells, also referred to by its code name, DEN-STEM. This treatment involves using the patient’s own cells to create a vaccine that targets cancer stem cells, which are believed to play a key role in the growth and spread of cancer.

The purpose of the study is to evaluate how effective this new treatment is in helping patients with glioblastoma live longer without their disease getting worse. Participants in the study will receive the treatment as an injection under the skin, known as an intradermal injection. The study will compare the effects of this treatment with those of standard therapy, which typically includes a combination of radiation and chemotherapy. Some participants may receive a placebo instead of the new treatment to help researchers understand its true effects.

Throughout the study, participants will undergo regular assessments, including MRI scans, to monitor the size and progression of their tumors. These assessments will help determine how well the treatment is working. The study aims to provide valuable information on whether this new immune therapy can improve outcomes for patients with glioblastoma.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and tumor characteristics.

A signed informed consent is required, ensuring understanding and agreement to participate in the study.

2 initial assessment

An initial assessment is conducted, including a postoperative MRI to evaluate the tumor remnant.

This assessment ensures that the tumor remnant is less than 1 cm³ or less than 10% of the original tumor volume.

3 standard therapy

Participants receive standard therapy, known as Stupp’s Regimen, which includes combined radiation therapy and chemotherapy.

This phase is crucial for preparing the body for the subsequent immunotherapy.

4 vaccine preparation

Tumor tissue is used to produce a vaccine, involving the proliferation of cells and extraction of tumor mRNA.

This vaccine is designed to target cancer stem cells in glioblastoma.

5 immunotherapy administration

The immunotherapy involves the administration of autologous cancer stem cell mRNA transfected dendritic cells.

This is given as a suspension for injection through intradermal injection.

6 monitoring and follow-up

Progression-free survival is monitored, defined as the time from the first surgery to the first certain progress of the tumor.

MRI evaluations are conducted at the start of vaccination, at week 25, and every 3 months thereafter to assess tumor response.

7 end of study

The study is estimated to conclude by December 31, 2026.

Final assessments will determine the therapeutic effect of the immunotherapy on progression-free survival.

Who Can Join the Study?

Must be at least 18 years and less than 70 years of age.
Must be able to walk and perform daily activities, with a ECOG performance status of 0 or 1. This means the patient is fully active or has some symptoms but can still do light work.
Must have a confirmed diagnosis of glioblastoma that is IDH wild type and has a non-methylated MGMT-gene promotor. This means specific genetic characteristics of the tumor are required.
Must be a candidate for combined radiation therapy and chemotherapy, known as the “Stupps Regimen.”
Must have enough tumor tissue available for making a vaccine. This involves growing cells and extracting tumor mRNA, which is a type of genetic material.
Must have a postoperative MRI after surgery showing a tumor remnant that is less than 1 cubic centimeter or less than 10% of the original tumor size. An MRI is a type of scan that shows detailed images of the inside of the body.
Must have normal organ function, as shown by lab tests.
Must test negative for contagious infections like HIV, HBV (Hepatitis B), HCV (Hepatitis C), and Treponema pallidum (which causes syphilis).
Must sign an informed consent form and agree to cooperate with the treatment and follow-up. This must be documented according to international and local regulations.

Who Cannot Join the Study?

Patients who are not diagnosed with glioblastoma, which is a type of brain cancer.
Patients who are younger than 18 years old.
Patients who are part of a vulnerable population, meaning they may have additional health or social challenges that make participation difficult.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.05.2018

Trial locations

Investigated drugs:

Temozolomide

Dendritic Cell Immunotherapy is a type of treatment that uses the patient’s own immune cells to fight cancer. In this trial, the therapy is designed to target cancer stem cells in patients with glioblastoma, a type of brain cancer. The goal is to help the immune system recognize and attack these cancer cells more effectively, potentially improving the patient’s progression-free survival.

Investigated diseases:

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often infiltrating surrounding brain tissue. The disease typically presents with symptoms such as headaches, seizures, and neurological deficits, depending on the tumor’s location. As it progresses, glioblastoma can cause increased pressure within the skull, leading to more severe symptoms. The tumor’s growth can be monitored using imaging techniques like MRI, which help assess changes over time. Despite its challenging nature, ongoing research aims to better understand and manage this condition.

Trial ID:

2024-518663-35-00

Protocol code:

DEN-STEM

NCT ID:

NCT03548571

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Effects of Dendritic Cell Immunotherapy and Temozolomide in Patients with Glioblastoma

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