Study on the Effectiveness and Safety of a Vaccine with Dendritic Cells for Patients with Newly Diagnosed Glioblastoma

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What is this study about?

This clinical trial is focused on studying a type of brain cancer called glioblastoma, which is a newly diagnosed and aggressive form of cancer. The treatment being tested is a vaccine made from the patient’s own immune cells, specifically autologous, tumor lysate-loaded, mature dendritic cells. This vaccine, known by the code name GlioVax, is given as an injection. The purpose of the study is to see if adding this vaccine to the standard treatment can help patients live longer compared to receiving the standard treatment alone.

The standard treatment for glioblastoma includes surgery to remove as much of the tumor as possible, followed by radiotherapy and chemotherapy with a drug called temozolomide. In this study, patients will receive the GlioVax vaccine in addition to these standard treatments. The vaccine is given intradermally, which means it is injected into the skin. The study will monitor patients over a period of time to assess their overall survival and any potential side effects from the vaccine.

Participants in the study will be closely observed to determine how well they respond to the treatment and to ensure their safety. The study will also evaluate the quality of life and neurological performance of the patients using various assessments. The goal is to find out if the vaccine can improve outcomes for patients with glioblastoma when used alongside the usual care. The study is expected to continue until 2027, providing valuable insights into the potential benefits of this new treatment approach.

1 initial treatment and surgery

The trial begins with the diagnosis of newly diagnosed glioblastoma. The patient undergoes a surgical procedure to remove the tumor. The goal is to achieve a near-complete resection, leaving a residual tumor volume of 5 ml or less.

A sterile tumor sample of at least 150 mg is collected during surgery. This sample is used to produce the personalized vaccine.

2 vaccine preparation

The collected tumor sample is processed to create a vaccine. This vaccine consists of autologous mature dendritic cells loaded with the patient’s own tumor lysate. The term ‘autologous’ means that the cells are derived from the patient’s own body.

3 standard radiochemotherapy

Following surgery, the patient receives standard treatment, which includes radiotherapy combined with temozolomide chemotherapy. Temozolomide is a medication taken orally to help fight cancer cells.

4 vaccine administration

The personalized vaccine is administered through an intradermal injection. This means the vaccine is injected into the skin. The schedule and frequency of these injections are determined by the study protocol.

5 adjuvant chemotherapy

After completing the initial radiochemotherapy, the patient continues with adjuvant temozolomide chemotherapy. This phase involves additional cycles of temozolomide to further target cancer cells.

6 monitoring and follow-up

Throughout the trial, the patient’s health and response to treatment are closely monitored. This includes regular MRI scans to check for tumor progression and assessments of overall and neurological performance.

The patient’s quality of life is evaluated using specific questionnaires designed to measure well-being and psychological stress.

Who Can Join the Study?

The patient must have a newly diagnosed condition called glioblastoma, which is a type of brain tumor.
The tumor must be monofocal, meaning it is located in one area, and it should be IDH wildtype, a specific genetic type of glioblastoma.
The tumor should be classified as WHO grade IV, which is a way to describe the severity of the tumor.
The tumor can include certain types called gliosarcoma and giant cell glioblastoma.
The tumor may extend into, but not beyond, a part of the brain called the corpus callosum.
A near-complete resection of the tumor must have been performed, meaning most of the tumor has been surgically removed, with no more than 5 milliliters of the tumor left, as confirmed by an MRI scan within 72 hours after surgery.
The surgery can be done while the patient is awake, and a second surgery is possible if needed for medical reasons.
A sterile tumor sample of at least 150 milligrams must be available, with at least 60% of the sample containing tumor cells, for the purpose of making a vaccine.
Both male and female patients can participate in the study.
The study includes patients who may be considered part of a vulnerable population, which means they might need extra protection or care.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with glioblastoma, which is a type of brain cancer.
Patients who are not within the specified age range for the study.
Patients who do not belong to the specific clinical trial group required for the study.
Patients who are not able to receive the standard treatment, which includes surgery, radiation therapy, and chemotherapy with a drug called temozolomide.
Patients who are unable to receive the additional treatment being tested in the study, which involves a special type of vaccine.
Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
HELIOS Klinikum Krefeld GmbH	Krefeld	Germany
Uplnjaiifnxxtinzqopmu Kzmqqnmlodgtjwaourdkfop Bzmqjl Ghbz	Bochum	Germany
Sbkf Ksilgutk Dnavwmay Gagl	Duisburg	Germany
Unejqoiivijfdzphloryg Dowcgbefmcz Ars	Duesseldorf	Germany
Uaiebttzfwzbkbdrzakgd Myrmdvbo Aqk	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.02.2018

Trial locations

Investigated drugs:

Autologous Mature Dendritic Cells Loaded With Autologous Tumor Lysate

Temozolomide is a chemotherapy medication used in the treatment of glioblastoma, a type of brain cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, temozolomide is used alongside radiotherapy as part of the standard treatment for newly diagnosed glioblastoma patients.

Lysate-loaded, mature dendritic cell vaccines are a type of immunotherapy used in this trial. These vaccines are made by loading dendritic cells, which are a type of immune cell, with tumor lysates. The goal is to stimulate the patient’s immune system to recognize and attack glioblastoma cells more effectively. This therapy is being tested as an additional treatment to the standard care for glioblastoma.

Investigated diseases:

Glioblastoma

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. Symptoms can include headaches, seizures, and neurological deficits such as weakness or speech difficulties, depending on the tumor’s location. The disease typically progresses quickly, with tumor cells spreading into nearby brain areas, making complete surgical removal challenging. As the tumor grows, it can cause increased pressure within the skull, leading to further neurological symptoms. The progression of glioblastoma is often monitored through imaging techniques like MRI to assess changes in tumor size and spread.

Trial ID:

2024-514820-18-00

Protocol code:

GlioVax

NCT ID:

NCT03395587

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of a Vaccine with Dendritic Cells for Patients with Newly Diagnosed Glioblastoma

What is this study about?

Who Can Join the Study?

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