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Study on Durvalumab and Radiation Therapy for Patients with Recurrent 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 recurrent glioblastoma, a type of brain cancer that has returned after treatment. The study is testing a combination of treatments to see if they can improve outcomes for patients with this condition. The treatments being studied include a type of radiation therapy called hypofractionated stereotactic radiation therapy, which delivers high doses of radiation to the tumor in a few sessions, and an immunotherapy drug called Durvalumab, also known by its code name Medi4736. Immunotherapy is a treatment that helps the body's immune system fight cancer.

The purpose of the study is to evaluate the safety and effectiveness of combining these two treatments. The study is divided into two phases. In the first phase, the focus is on assessing the safety and tolerability of the treatment combination. In the second phase, the study aims to determine if the combination of treatments can improve the overall survival of patients compared to using radiation therapy alone. Participants will receive the treatments and be monitored over time to see how they respond.

Throughout the study, participants will undergo regular check-ups and tests, including MRI scans, to track the progress of their disease and any side effects from the treatments. The study will also look at how the treatments affect the quality of life and cognitive functions of the participants. The trial is expected to continue until 2026, with ongoing assessments to gather comprehensive data on the treatment's impact on recurrent 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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure adequate health status.
Eligibility criteria include being 18 years or older, having a confirmed diagnosis of recurrent glioblastoma, and meeting specific health requirements such as adequate blood counts and organ function.
Step 2
Treatment phase I
The first phase of treatment involves the administration of hypofractionated stereotactic radiation therapy combined with Durvalumab.
Durvalumab is given as an intravenous infusion. The dosage and frequency are determined by the study protocol and are monitored for safety and tolerability.
Step 3
Monitoring and evaluation phase I
During this phase, the safety and tolerability of the treatment are closely monitored. This includes regular health check-ups and assessments using specific scales and questionnaires.
The primary focus is on identifying any adverse effects and ensuring the treatment is safe for continued use.
Step 4
Treatment phase II
If the treatment is deemed safe, the study progresses to phase II, where the effectiveness of the combination therapy is evaluated.
The goal is to determine if the combination of radiation therapy and Durvalumab improves overall survival compared to radiation therapy alone.
Step 5
Monitoring and evaluation phase II
In this phase, the focus is on measuring overall survival and progression-free intervals. Regular assessments are conducted to monitor the patient's health and response to treatment.
Quality of life and neurocognitive functions are also evaluated using standardized questionnaires and tests.
Step 6
Follow-up
After completing the treatment phases, follow-up visits are scheduled to continue monitoring the patient's health and any long-term effects of the treatment.
These visits help in gathering data on the long-term safety and effectiveness of the treatment.

Who can join the trial?

19 criteria

Must be **18 years or older** at the time of joining the study.
Must have a **Karnofsky performance status** of 70 or higher. This is a scale that measures the ability to carry out daily activities.
Must have **adequate blood, kidney, and liver function**. This means certain blood tests must show normal levels, such as:
- **Absolute Neutrophil Count**: 1500 or more per mm³
- **Hemoglobin**: 9.0 g/dL or higher
- **Platelet count**: 100,000 or more per mm³
- **Total bilirubin**: 1.5 times the upper limit of normal (ULN) or less, unless you have Gilbert's syndrome, then 3 times ULN or less
- **ALT and AST**: 2.5 times ULN or less. These are liver enzymes.
- **Creatinine**: 1.5 times ULN or less, or a creatinine clearance of 40 mL/min or more. This measures kidney function.
- Female patients must either be unable to have children or have a **negative pregnancy test** when entering the study.
- Must provide **written informed consent** and any necessary local authorizations before any study procedures begin.
- Must be **willing and able to follow the study protocol**, including attending treatments, visits, and exams.
- Must have a **previous confirmation of glioblastoma** through a tissue sample.
- Must have a **recurrence of glioblastoma** confirmed by an MRI scan within 28 days before starting radiation therapy. Recurrence means the cancer has returned after treatment.
- Must have a **recurrent nodule** of a confirmed diagnosis of a Grade IV malignant glioma, which is a type of brain tumor.
- Must have **recurrent disease** shown by MRI with a size of 35mm or less on a specific type of MRI scan.
- Must be a patient for whom **re-irradiation** has been decided by a team of medical experts.
- Must have **measurable disease**, meaning the tumor can be measured by scans.
- Must have completed any **prior radiotherapy** at least 12 weeks before starting the new radiation therapy, unless there is clear evidence of tumor progression outside the previous radiation area.
- If previously treated with **anti-VEGF/VEGFR therapy**, there must be at least 28 days between the last treatment and the start of the new radiation therapy. This therapy targets blood vessel growth in tumors.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than recurrent glioblastoma cannot participate. Recurrent glioblastoma is a type of brain cancer that has come back after treatment.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had another cancer treatment recently that might interfere with the study cannot participate.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who are part of another clinical trial at the same time cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centr Georges Francois Leclerc
Dijon, France
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Centre Francois Baclesse
Caen, France
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Hopital Beaujon
Clichy, France

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Investigated drugs

Durvalumab is an immunotherapy medication used in this trial. It works by helping the body's immune system recognize and attack cancer cells. In this study, it is being tested to see if it can improve the treatment outcomes for patients with recurrent glioblastoma when used in combination with radiation therapy. Hypofractionated stereotactic radiation therapy is a type of radiation treatment that delivers high doses of radiation to a specific area of the brain over a shorter period. This therapy aims to target and destroy cancer cells in patients with recurrent glioblastoma, potentially improving their survival and quality of life.

Durvalumab

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating recurrent glioblastoma, a type of brain cancer. The main therapeutic indication for Durvalumab in this context is to potentially improve overall survival when combined with radiation therapy. At the molecular level, Durvalumab works by blocking the PD-L1 protein, which can help the immune system recognize and attack cancer cells more effectively. It is classified as an immunotherapy drug, specifically a PD-L1 inhibitor.

Investigated diseases

Recurrent Glioblastoma – Recurrent glioblastoma is a type of brain tumor that originates from glial cells, which are supportive cells in the brain. It is characterized by its aggressive nature and tendency to grow rapidly. After initial treatment, this tumor often returns, which is referred to as recurrence. The tumor can cause symptoms such as headaches, seizures, and neurological deficits depending on its location in the brain. As it progresses, it may lead to increased pressure within the skull and further neurological complications. The recurrence of glioblastoma poses significant challenges in management due to its resistance to conventional therapies.