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Autologous Mature Dendritic Cells Loaded With Autologous Tumor Lysate

This article discusses clinical trials using a novel treatment approach for newly diagnosed glioblastoma, a type of brain cancer. The treatment involves using a patient’s own immune cells, specifically mature dendritic cells loaded with the patient’s tumor lysate, as a vaccine. This personalized immunotherapy is being studied in combination with standard treatments to potentially improve survival outcomes for glioblastoma patients.

Table of Contents

What is Autologous Mature Dendritic Cells Loaded with Autologous Tumor Lysate?

Autologous Mature Dendritic Cells Loaded with Autologous Tumor Lysate is a type of personalized cancer vaccine[1]. This treatment, also known by its sponsor product code “GlioVax,” is designed to harness the power of your own immune system to fight cancer[1]. Let’s break down what this means:

  • Autologous: This means the treatment is made from your own cells and tissues.
  • Mature Dendritic Cells: These are special immune cells that help your body recognize and fight off harmful substances, including cancer cells.
  • Tumor Lysate: This is a solution containing broken-down tumor cells from your own cancer.

How Does It Work?

The treatment works by “training” your immune system to recognize and attack your specific cancer cells[1]. Here’s a simplified explanation of the process:

  1. During surgery to remove your tumor, a sample of the tumor is collected.
  2. Scientists extract dendritic cells from your blood.
  3. In the lab, they expose these dendritic cells to the broken-down tumor cells (tumor lysate).
  4. This “teaches” the dendritic cells to recognize your specific cancer cells as threats.
  5. The prepared vaccine is then injected back into your body, where it helps your immune system identify and attack the cancer cells.

What Condition Does It Treat?

This treatment is being studied for newly diagnosed glioblastoma[1]. Glioblastoma is a type of brain cancer that forms from glial cells (cells that support and protect nerve cells). It’s considered a grade IV tumor, which means it’s an aggressive cancer that can grow and spread quickly[1].

Current Clinical Trial

A Phase II clinical trial is currently underway to test this treatment[1]. The trial is titled “Phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastoma”[1].

In this trial, the vaccine is being tested as an add-on to the standard treatment for glioblastoma, which includes:

  • Surgery to remove as much of the tumor as possible
  • Radiation therapy
  • Chemotherapy with a drug called temozolomide

Who Can Participate in the Trial?

The trial has specific criteria for who can participate. Some key points include[1]:

  • Patients must have newly diagnosed glioblastoma, confirmed by a specialist.
  • The tumor must be mostly removed during surgery (less than 5 ml remaining).
  • A sterile tumor sample of at least 150 mg must be available to make the vaccine.

There are also conditions that might prevent someone from participating, such as certain other medical conditions or planned major surgeries[1].

What Are the Trial Objectives?

The main goal of the trial is to see if adding this vaccine to standard treatment helps patients live longer[1]. Researchers will measure this by comparing how long patients who receive the vaccine live compared to those who only receive standard treatment.

Other objectives include[1]:

  • Measuring how long patients live without their cancer getting worse (called progression-free survival)
  • Comparing survival rates at 6, 12, and 24 months
  • Assessing the safety of the treatment
  • Evaluating patients’ overall health and brain function
  • Assessing patients’ quality of life

Safety Monitoring and Quality of Life Assessment

The trial includes careful monitoring of side effects and how well patients tolerate the treatment[1]. Researchers will track any adverse events and grade their severity according to standardized criteria.

They will also assess patients’ overall health and brain function using specific tests (KPS and MMSE-2)[1]. Quality of life will be measured using questionnaires that look at general well-being, symptoms specific to brain tumors, and psychological stress[1].

Aspect Details
Trial Type Phase II clinical trial
Condition Newly diagnosed glioblastoma
Treatment Autologous mature dendritic cells loaded with autologous tumor lysate vaccine
Administration Intradermal injection
Primary Endpoint Overall survival from day of surgery until death
Secondary Endpoints Progression-free survival, survival rates at 6, 12, and 24 months, safety profile, overall and neurological performance, quality of life
Key Inclusion Criteria Newly diagnosed GBM, near-complete resection, sufficient tumor sample for vaccine production
Key Exclusion Criteria Severe medical conditions, immunosuppression, chronic renal disease, uncontrolled cardiovascular issues, severe diabetes

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to determine if using a vaccine made from a patient's own dendritic cells loaded with their tumor lysate, in addition to standard treatment, can improve overall survival in patients with newly diagnosed glioblastoma compared to standard treatment alone.
  • Who is eligible for this clinical trial? Eligible patients are those with newly diagnosed, monofocal glioblastoma (WHO grade IV) who have undergone near-complete tumor resection and have a sufficient tumor sample available for vaccine production.
  • How is the vaccine administered? The vaccine is administered through intradermal injection, with a maximum daily dose of 1 ml and a maximum total dose of 7 ml over a treatment period of up to 34 weeks.
  • What are the secondary objectives of the trial? Secondary objectives include comparing progression-free survival, survival rates at specific time points, assessing the safety profile, evaluating overall and neurological performance, and measuring quality of life between the two treatment groups.
  • How is the effectiveness of the treatment measured? The primary measure of effectiveness is overall survival, calculated from the day of surgery until death. Secondary measures include progression-free survival, survival rates at 6, 12, and 24 months, and various quality of life and performance assessments.

Ongoing Clinical Trials on Autologous Mature Dendritic Cells Loaded With Autologous Tumor Lysate

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Glioblastoma (GBM): A fast-growing and aggressive type of brain cancer, classified as a grade IV astrocytoma.
  • Dendritic Cells: Immune cells that process and present antigens to other cells of the immune system, playing a crucial role in initiating an immune response.
  • Tumor Lysate: A solution containing the broken-down components of tumor cells, used to stimulate an immune response against the tumor.
  • Overall Survival (OS): The length of time from the start of treatment (in this case, surgery) until death from any cause.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without the cancer progressing or getting worse.
  • RANO Criteria: Response Assessment in Neuro-Oncology criteria, used to evaluate the response to treatment in brain tumors.
  • Karnofsky Performance Status (KPS): A scale used to measure a patient's general well-being and activities of daily life.
  • Mini-Mental State Examination (MMSE-2): A test used to measure cognitive impairment and screen for dementia.
  • Quality of Life (QoL): A measure of an individual's well-being that includes physical, mental, and social aspects of life.
  • Intradermal Injection: A method of injecting a substance directly into the dermis, the layer of skin just below the epidermis.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-a-vaccine-with-dendritic-cells-for-patients-with-newly-diagnosed-glioblastoma/