Not recruitingRare disease

Study on WT1 LAMP mRNA DC and Temozolomide for Patients with Newly Diagnosed 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, which is known for being aggressive and difficult to treat. The study is exploring a new treatment approach that combines a special type of immunotherapy with a drug called temozolomide. The immunotherapy involves using a vaccine made from the patient's own immune cells, which are modified to recognize and attack cancer cells. This vaccine is known as WT1 LAMP mRNA DC and is given as an injection under the skin.

The purpose of the study is to see if adding this vaccine to the standard treatment with temozolomide can help patients live longer and prevent the cancer from getting worse. Patients who have recently been diagnosed with glioblastoma and have undergone surgery to remove the tumor, followed by a combination of chemotherapy and radiation, are eligible to participate. The study will involve regular injections of the vaccine, along with continued treatment with temozolomide, to see how well this combination works.

Participants in the study will receive either the vaccine or a placebo, in addition to temozolomide, and will be monitored over time to assess their health and response to the treatment. The study aims to gather information on the safety and effectiveness of this new treatment approach, with the hope of improving outcomes for patients with glioblastoma.

The research process

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

Step 1
Surgery and initial treatment
Undergo surgery for the removal of the glioblastoma tumor. This may involve total or subtotal resection, as determined by the neurosurgeon.
Begin chemoradiation treatment within 28 to 49 days following surgery. This involves a combination of chemotherapy and radiation therapy to target any remaining cancer cells.
Step 2
Leukapheresis procedure
Participate in a leukapheresis procedure. This process involves collecting white blood cells from the blood, which are necessary for creating the personalized vaccine.
Step 3
Dendritic-cell vaccine preparation
The collected white blood cells are used to prepare a personalized vaccine. This vaccine is designed to help the immune system recognize and attack glioblastoma cells.
Step 4
Initiation of adjuvant therapy
Begin adjuvant therapy with temozolomide, a chemotherapy drug, to help prevent the cancer from returning. This is administered following the completion of chemoradiation.
Step 5
Dendritic-cell vaccine administration
Receive the WT1 LAMP mRNA DC vaccine through intradermal injection. This is administered every three weeks following chemoradiation.
Additional vaccine doses are given on day 21 of each maintenance chemotherapy cycle.
Step 6
Monitoring and follow-up
Regular monitoring of health and response to treatment is conducted. This includes assessing overall survival and progression-free survival.
Safety and immune response are evaluated through various tests and assessments.

Who can join the trial?

10 criteria

Must have a newly diagnosed glioblastoma, which is a type of brain tumor, confirmed by a medical test.
Must have a life expectancy of at least 3 months, as estimated by the doctor.
Must be 18 years or older.
Must have had a total or subtotal resection of the tumor. This means the tumor was mostly or completely removed by surgery. A total resection means no visible tumor remains, while a subtotal resection means a small amount of tumor may still be visible.
Must have signed an informed consent, which means agreeing to participate after understanding the study details.
Must be willing and able to follow the study plan, as judged by the doctor.
Must be ready to start chemoradiation (a combination of chemotherapy and radiation therapy) between 28 and 49 days after surgery.
Must be fit to undergo leukapheresis (a procedure to collect white blood cells), chemoradiation, chemotherapy, and immunotherapy.
Must not have taken corticosteroid treatment (a type of medication) within 1 week before the apheresis procedure.
Must have a WHO performance status of 2 or less, which is a measure of the ability to perform daily activities.

Who cannot join the trial?

9 criteria

Patients who have not been newly diagnosed with glioblastoma grade IV. Glioblastoma is a type of brain cancer, and grade IV indicates it is very aggressive.
Patients who have not undergone (sub)total resection. This means the patient must have had surgery to remove most or all of the tumor.
Patients who have not received temozolomide-based chemoradiation. Temozolomide is a medication used to treat brain tumors, and chemoradiation is a combination of chemotherapy and radiation therapy.
Patients who are not eligible for adjuvant temozolomide maintenance treatment. This is a continued treatment with temozolomide after the initial therapy to help prevent the cancer from coming back.
Patients who are not suitable for the autologous Wilms' tumor 1 mRNA-loaded dendritic-cell vaccination. This is a type of vaccine made from the patient's own cells to help the immune system fight the cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population that is not selected for this study.

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Verified sites

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University Of Antwerp
Edegem, Belgium

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Investigated drugs

Temozolomide
is a medication used in this trial as part of the treatment for patients with newly diagnosed glioblastoma. It is a type of chemotherapy that helps to stop the growth of cancer cells. In this study, it is used after surgery and radiation therapy to help maintain the treatment's effectiveness.
Autologous Wilms' Tumor 1 mRNA-loaded Dendritic-Cell Vaccination
is an experimental therapy being tested in this trial. It involves using the patient's own immune cells, which are modified to recognize and attack cancer cells. This therapy is added to the standard treatment with temozolomide to see if it can improve survival rates and delay the progression of the disease.

Wt1 Lamp Mrna Dc

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 types of brain tumors, particularly glioblastoma. Temozolomide is primarily used to treat glioblastoma grade IV, often in combination with other therapies. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. Temozolomide is classified as an alkylating agent, a type of chemotherapy drug.
Dendritic-Cell Immunotherapy
This treatment is administered through injections. It is an emerging therapy in medical research, particularly in clinical trials for cancer treatment. The main therapeutic indication is for glioblastoma grade IV. This immunotherapy involves using the patient's own dendritic cells, which are loaded with Wilms' tumor 1 mRNA, to stimulate the immune system to attack cancer cells. It is classified under immunotherapy, a type of treatment that uses the body's immune system to fight cancer.

Investigated diseases

Glioblastoma – Glioblastoma is an aggressive type of cancer that occurs in the brain or spinal cord. It originates from cells called astrocytes that support nerve cells. This disease is known for its rapid growth and tendency to invade nearby brain tissue, making it difficult to treat. Symptoms can vary depending on the tumor's location and may include headaches, nausea, seizures, and neurological deficits. As the disease progresses, these symptoms often worsen, and new symptoms may develop. Glioblastoma is classified as a grade IV tumor, indicating its high malignancy and aggressive nature.