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Study on the Safety and Effectiveness of a Dendritic Cell Vaccine and Temozolomide for Patients with Glioblastoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of brain cancer called glioblastoma. The study involves a treatment that combines a special vaccine and a medication. The vaccine, known as DC-VACCINE_IRSTIRCCS, is made from the patient's own tumor cells and is designed to help the immune system recognize and fight the cancer. The medication used in this study is called temozolomide, which is taken in the form of hard capsules. Temozolomide is a chemotherapy drug that helps to stop the growth of cancer cells.

The purpose of the study is to assess the safety and effectiveness of this combined treatment in patients who have had surgery for glioblastoma and are receiving standard radiochemotherapy. Participants in the study will receive the vaccine and temozolomide over a period of several months. The study will monitor how well the treatment works in preventing the cancer from getting worse and will also look at any side effects that may occur.

Throughout the study, participants will be closely observed to see how their bodies respond to the treatment. The researchers aim to understand if the combination of the vaccine and temozolomide can improve the chances of stopping the cancer from progressing and to evaluate the overall survival of the patients. This study hopes to provide valuable insights into new ways of treating glioblastoma and improving patient outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    The trial begins with the administration of standard radiochemotherapy, known as the Stupp regimen, which is a common treatment for glioblastoma. This phase is necessary to prepare for the subsequent steps in the trial.

  2. Step 2

    Leukapheresis

    Leukapheresis is a procedure to collect white blood cells from the patient. These cells are used to create a personalized vaccine. This step is crucial for the preparation of the autologous dendritic cell vaccine.

  3. Step 3

    Vaccine preparation

    The collected cells are sent to a specialized laboratory where they are processed to create the autologous tumor lysate-loaded dendritic cells. This vaccine is designed to help the immune system recognize and fight the tumor.

  4. Step 4

    Vaccine administration

    The vaccine is administered intradermally (under the skin). This process involves multiple injections over a specified period. The goal is to stimulate the immune system to target the glioblastoma cells.

  5. Step 5

    Temozolomide treatment

    During the trial, temozolomide is administered in the form of hard capsules. The dosage and frequency are determined based on individual patient needs and the trial protocol. Temozolomide is an oral medication that helps to prevent the growth of cancer cells.

  6. Step 6

    Monitoring and follow-up

    Regular monitoring is conducted to assess the patient's response to the treatment. This includes evaluating the progression-free survival, which measures the time during which the disease does not worsen. The occurrence of any adverse events is also closely monitored.

Who can join the trial?

10 criteria

  • Must have a **confirmed diagnosis** of glioblastoma, which is a type of brain tumor.
  • If you are a woman who can have children or a man with a partner who can have children, you must agree to use **effective birth control** during the study and for 4 months after.
  • Must have **recovered** from any side effects of previous treatments to a mild level or less.
  • The **tumor sample** needed for making the vaccine must have been collected and sent to the lab and meet all required standards.
  • There must be enough **blood cells** collected to prepare the vaccine.
  • Must have a **Karnofsky performance status** of 70% or higher, which means you can take care of yourself and do normal activities, or a performance status of 0 or 1 on the **ECOG Performance Scale**, which measures your ability to do daily activities.
  • Must be willing and able to **sign a consent form** to participate in the trial.
  • Must be **18 years or older** at the time of signing the consent form.
  • Must have a **life expectancy** of more than 12 weeks.
  • Must have **normal organ and bone marrow function**, meaning your organs and bone marrow are working properly.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with glioblastoma, which is a type of brain tumor.
  • Patients who have not undergone surgery for glioblastoma.
  • Patients who have not received standard treatment with radiochemotherapy, which is a combination of radiation and chemotherapy, following the Stupp regimen, a specific treatment plan for glioblastoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care.
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Investigated drugs

  • Dendritic Cell Vaccine

    is a type of immunotherapy used in this trial. It involves using the patient's own immune cells, called dendritic cells, which are loaded with proteins from the patient's tumor. This personalized vaccine aims to help the immune system recognize and attack the glioblastoma tumor cells.

  • Temozolomide

    is a chemotherapy medication used in this trial. It is taken by mouth and works by slowing or stopping the growth of cancer cells. In this study, it is used in combination with the dendritic cell vaccine to treat patients with glioblastoma after they have undergone surgery and standard radiochemotherapy.

What is already known about the treatment

Temozolomide – This medication is administered orally in the form of capsules. It is currently well-established in medical practice and literature as a treatment for certain brain cancers, particularly glioblastoma. Temozolomide is primarily used to treat glioblastoma, a type of aggressive brain tumor. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. This medication is classified as an alkylating agent, a type of chemotherapy drug.

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. Symptoms can vary depending on the tumor's location but may include headaches, seizures, and changes in personality or cognitive function. As the disease progresses, these symptoms typically worsen, and new neurological deficits may appear. Glioblastoma is characterized by its tendency to recur even after treatment, making it a challenging condition to manage. The tumor's complex biology and resistance to conventional therapies contribute to its aggressive progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512493-98-00Protocol codeIRST191.05Estimated enrolment28 patientsSponsorIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

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