Study on Bevacizumab for Patients with Newly Diagnosed IDH Wild-Type, MGMT Unmethylated 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 study is investigating a treatment that combines radiochemotherapy with a medication called bevacizumab. Bevacizumab is given as a solution through an infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to explore how this treatment affects the overall survival of patients who have been newly diagnosed with a specific form of glioblastoma that is IDH wild-type and MGMT unmethylated.

Participants in the study will receive the treatment over a period of time, and their health will be monitored to assess the safety and tolerability of the treatment. The study will also look at how long patients live without the disease getting worse, which is known as progression-free survival. Additionally, the study will evaluate the quality of life and cognitive function of the participants, using specific questionnaires and tests designed to measure these aspects.

The study aims to gather information that could help improve treatment strategies for glioblastoma in the future. It will also explore the potential of using certain biological markers, called 4-miRNA signature-based risk subgroups, to better understand the disease and its progression. The study is expected to continue until 2027, with recruitment of participants starting in 2024.

1 initiation of treatment

Upon joining the study, the patient will begin treatment for glioblastoma, a type of brain tumor.

The treatment involves the use of a medication called bevacizumab, which is administered as a solution for infusion through an intravenous route.

2 medication administration

The patient will receive bevacizumab at a concentration of 25 mg/ml. The specific dosage and frequency will be determined by the healthcare provider based on individual needs and response to treatment.

The medication is designed to inhibit VEGF (vascular endothelial growth factor), which can help in managing the tumor.

3 radiochemotherapy

In addition to bevacizumab, the patient will undergo radiochemotherapy. This involves the use of radiation therapy combined with chemotherapy to target cancer cells more effectively.

The dose of radiation will be adjusted to achieve an isotoxic dose escalation, meaning the dose is increased to the highest level that does not cause unacceptable side effects.

4 monitoring and assessments

Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular assessments of overall survival, safety, and tolerability of the treatment.

Additional evaluations will focus on progression-free survival, quality of life, and cognitive function using specific questionnaires and tests.

5 completion of trial

The trial is expected to continue until March 31, 2027. The patient will be part of the study until the end date or until it is determined that they should discontinue for health reasons.

Upon completion, the data collected will contribute to understanding the effectiveness and safety of the treatment regimen.

Who Can Join the Study?

The patient must have a confirmed diagnosis of glioblastoma, which is a type of brain tumor. Specific tests must show certain characteristics of the tumor, and MRI images should be taken within 2 weeks before starting radiation therapy.
Women who can become pregnant must not be breastfeeding and must have a negative pregnancy test within 7 days before starting the study treatment. Both men and women must use effective birth control during the study and for 6 months after.
The patient must be between 18 and 70 years old, and can be a smoker or non-smoker of any ethnic background.
The patient must have an ECOG Performance Status of 0 to 2, which is a scale used to assess how a patient’s disease is affecting their daily living abilities.
The patient must have signed an informed consent form, which means they understand the study and agree to participate. This includes agreeing to data protection rules.
The site of any previous brain surgery or biopsy must be properly healed, with no signs of infection or drainage, and the skull repair must be intact.
The patient must have adequate blood health, including a certain level of white blood cells, neutrophils, platelets, and hemoglobin. These are important components of the blood that help fight infection and carry oxygen.
The patient must have adequate liver function, meaning certain liver enzymes and bilirubin levels must be within a specific range.
The patient must have adequate kidney function, with specific levels of creatinine and protein in the urine.
The patient must have a certain level of INR (a measure of blood clotting) if not on blood-thinning medication. If on such medication, the INR must be stable and within a certain range. The preferred blood-thinning treatment during the study is low molecular weight heparin.

Who Cannot Join the Study?

Patients who have a different type of cancer than glioblastoma cannot participate. Glioblastoma is a specific type of brain cancer.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not part of the specified clinical trial group cannot participate. The study is looking for certain characteristics in participants.
Patients who are not able to give informed consent or are considered part of a vulnerable population may not be eligible. This means the study wants to ensure participants fully understand and agree to the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Uviqdpkriohxvvgohrqhh Aefzbnws	Augsburg	Germany
Uutygyeyhy Haiquqkk Cjqbbaf	Cologne	Germany
Gvhsdl Uztamzlilb Fzzllkmxb	Frankfurt	Germany
Kujmcytt dmg Uvuxwaiadelb Mjtqpfwk Amh	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	31.03.2024

Trial locations

Investigated drugs:

Bevacizumab

Bevacizumab is a medication used in this clinical trial to help protect against the growth of new blood vessels that tumors need to grow. It works by inhibiting a protein called VEGF, which is involved in the formation of blood vessels. In this study, bevacizumab is used alongside other treatments to see if it can improve the overall survival of patients with a specific type of brain cancer called glioblastoma.

Investigated diseases:

Glioblastoma

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 challenging to manage. Symptoms often include headaches, nausea, confusion, and memory problems, which can worsen as the tumor grows. Glioblastoma can affect various brain functions depending on its location, leading to changes in personality, mood, and cognitive abilities. The progression of the disease is typically swift, with symptoms intensifying over time.

Trial ID:

2024-514865-20-00

Protocol code:

PRIDE

NCT ID:

NCT05871021

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Bevacizumab for Patients with Newly Diagnosed IDH Wild-Type, MGMT Unmethylated Glioblastoma

What is this study about?

Who Can Join the Study?

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