Not recruitingRare disease

Study on the Use of PD L 506 and Aminolevulinic Acid Hydrochloride for New Glioblastoma in Adults

Verified siteRegistered drugNo placebo

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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 is specifically looking at a form of glioblastoma that is newly diagnosed and located in a particular part of the brain. The treatment being tested is called PD L 506, which is used in a procedure known as stereotactic interstitial photodynamic therapy, or iPDT. This therapy involves using light to activate a drug in the body to help treat the cancer.

The purpose of the study is to determine how safe and tolerable this new treatment is for patients with this type of glioblastoma. During the study, participants will receive the treatment and be monitored for any side effects or adverse reactions. The study will track the occurrence of any significant side effects within two weeks after the treatment is administered.

Participants in the study will be adults who have been newly diagnosed with this specific type of glioblastoma. The study will help researchers understand more about the potential benefits and risks of using PD L 506 in treating glioblastoma, which could lead to new treatment options for patients in the future.

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
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the safety and tolerability of a treatment called stereotactic interstitial photodynamic therapy (iPDT) using a substance known as PD L 506.
The patient will be required to provide written informed consent, confirming their understanding and agreement to participate in the study.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of glioblastoma and ensuring the tumor meets specific criteria, such as size and location.
Additional assessments will include checking the patient's overall health status, including blood tests to ensure adequate blood cell counts and liver function.
Step 3
Treatment preparation
The patient will be prepared for the treatment phase, which involves the administration of aminolevulinic acid hydrochloride in the form of an oral solution called Gliolan 30 mg/ml.
The medication is taken orally to help highlight the tumor during the photodynamic therapy.
Step 4
Photodynamic therapy
The patient will undergo the stereotactic interstitial photodynamic therapy (iPDT). This involves using light to activate the medication within the tumor, aiming to destroy cancer cells.
The procedure is performed under medical supervision to ensure safety and effectiveness.
Step 5
Post-treatment monitoring
Following the therapy, the patient will be monitored for any side effects or adverse reactions. This monitoring period lasts for two weeks.
The focus will be on identifying any treatment-emergent adverse events, particularly those of higher severity.
Step 6
Follow-up assessments
The patient will have regular follow-up assessments to evaluate the treatment's impact on the tumor and overall health.
These assessments will include imaging tests and clinical evaluations to track progress and detect any changes.

Who can join the trial?

13 criteria

The patient must have a **newly diagnosed** type of brain tumor called **glioblastoma** that is located in a specific part of the brain called the **supratentorial region**.
The tumor must be **unifocal**, meaning it is a single tumor, and **lobar located**, meaning it is in one of the brain's lobes.
The tumor must be **IDH wild-type**, which is a specific genetic characteristic of the tumor.
The tumor should not be safely or completely removable and must have a largest diameter of **40 mm or less** as seen on an MRI scan.
The patient must be between **18 and 70 years old**.
The patient must have a **Karnofsky Performance Status (KPS)** of **70% or higher**, which is a measure of their ability to carry out daily activities.
The patient must have a **minimum life expectancy of 3 months**.
The patient must be eligible for **radiotherapy** and **chemotherapy** with a drug called **temozolomide**.
The patient must have **adequate blood function**, meaning certain blood cell counts and hemoglobin levels must be above specific thresholds.
The patient must have normal blood clotting times, specifically **INR** or **PT** and **aPTT** values that are **1.5 times or less** than the upper limit of normal.
Women who can become pregnant must have a **negative pregnancy test**.
Both male and female patients who can have children must agree to use **highly effective birth control** methods during the study.
The patient must provide **written informed consent**, meaning they agree to participate in the study after understanding all the details.

Who cannot join the trial?

8 criteria

Patients who have a different type of brain tumor other than glioblastoma. Glioblastoma is a specific kind of brain cancer.
Patients who have a genetic mutation called IDH mutation. This is a change in a gene that can affect how the tumor behaves.
Patients who are not adults. The study is only for adult patients.
Patients who have other serious health conditions that might interfere with the study treatment.
Patients who are unable to give their own consent to participate in the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medication or its ingredients.

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Verified sites

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

Verified
Klinikum der Universitaet Muenchen AöR
Munich, Germany
Verified
Universitaetsklinikum Muenster AöR
Munster, Germany
Verified
University Hospital Cologne
Cologne, Germany

Trial locations

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Investigated drugs

PD L 506 is a medication being studied for its use in stereotactic interstitial photodynamic therapy (iPDT). This therapy is being tested in adult patients who have been newly diagnosed with a specific type of brain cancer called supratentorial IDH wild-type glioblastoma. The main goal of using PD L 506 in this trial is to evaluate its safety and how well patients can tolerate it when used in this type of cancer treatment.

Aminolevulinic Acid Hydrochloride

What is already known about the treatment

PD L 506 – This medication is administered through stereotactic interstitial photodynamic therapy, a method that involves delivering light-sensitive drugs directly to the tumor site in the brain. Currently, PD L 506 is being evaluated in clinical trials for its safety and tolerability in treating newly diagnosed supratentorial IDH wild-type glioblastoma, a type of brain cancer. The main therapeutic indication for PD L 506 is glioblastoma, where it aims to target and destroy cancer cells. At the molecular level, PD L 506 works by activating a photosensitizer with light, which produces reactive oxygen species that damage and kill tumor cells. It is classified pharmacologically as a photosensitizing agent used in photodynamic therapy.

Investigated diseases

Glioblastoma – Glioblastoma is an aggressive type of cancer that occurs in the brain or spinal cord. It arises from astrocytes, which are cells that support nerve cells. This disease is characterized by rapid growth and a 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. Glioblastoma is known for its complex and heterogeneous nature, often leading to varied clinical presentations. The progression of the disease is typically swift, with changes in symptoms occurring over a short period.