Study of L19TNF and Lomustine for Patients with Recurrent or Progressive Glioblastoma

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What is this study about?

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 testing a combination of two treatments: L19TNF and lomustine. L19TNF, also known by its code name Fibromun, is given as an injection into the veins, while lomustine is taken as a capsule by mouth. The purpose of the study is to find the best combination of doses for these two treatments that can help manage glioblastoma when it gets worse or comes back after initial treatment.

Participants in the study will receive different doses of L19TNF and lomustine to see which combination works best and has the fewest side effects. The study will last for a period of time, during which participants will have regular check-ups and tests to monitor their health and the effects of the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study aims to improve understanding of how these treatments can help people with glioblastoma, focusing on safety and effectiveness. Researchers will look at various outcomes, such as how long patients live after treatment and how long they remain free from cancer progression. The study will also monitor any side effects and how the body processes the treatments. This research hopes to provide valuable information that could lead to better treatment options for glioblastoma in the future.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where you will be asked to provide a signed and dated informed consent document. This document confirms that you have been informed about all important aspects of the study.

During this visit, your eligibility will be confirmed based on specific criteria, such as age, medical history, and current health status. You will need to have a negative test for certain infections and, if applicable, a negative pregnancy test.

2 baseline assessments

Before starting the treatment, baseline assessments will be conducted. These may include laboratory tests, imaging studies like MRI, and physical examinations to establish your current health status.

These assessments help in monitoring your health throughout the study and in evaluating the effects of the treatment.

3 treatment initiation

The treatment involves two medications: lomustine and Fibromun (also known as L19TNF).

Lomustine is administered orally in the form of a hard capsule. The dosage and frequency will be determined based on the study schedule you are assigned to.

Fibromun is given through an intravenous infusion, which means it is delivered directly into your bloodstream through a vein. The dosage and frequency will also depend on the study schedule.

4 ongoing monitoring

Throughout the study, regular visits will be scheduled to monitor your health and the effects of the treatment. These visits will include physical examinations, laboratory tests, and possibly imaging studies.

You will be asked to report any side effects or changes in your health. The study team will assess the safety and effectiveness of the treatment based on these observations.

5 end of treatment

At the end of the treatment period, final assessments will be conducted to evaluate your health and the overall impact of the treatment.

These assessments will help determine the effectiveness of the treatment and any long-term effects.

6 follow-up

After completing the treatment, follow-up visits may be scheduled to continue monitoring your health and to gather additional data on the treatment’s long-term effects.

These visits are important for ensuring your well-being and for contributing to the study’s findings.

Who Can Join the Study?

Must be a male or female aged 18 or older.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
Must have a confirmed diagnosis of glioblastoma (a type of brain tumor) according to the 2021 WHO classification, with progression as per RANO criteria.
If surgery was performed, the histological report must show glioblastoma recurrence, and a new MRI must be done 3-5 weeks after surgery, before starting the study treatment. Treatment must start at least 4 weeks after surgery.
Must have known MGMT promoter status (a specific genetic marker related to the tumor).
Must have a Karnofsky Performance Status (KPS) of 60% or higher. This is a scale that measures the ability to perform daily activities, where 100% means fully active and 0% means deceased.
Must have a documented negative test for HIV, HBV (Hepatitis B), and HCV (Hepatitis C). For Hepatitis B, specific tests are required, and if there was previous exposure, a negative HBV-DNA test is needed unless there is a vaccination report. For Hepatitis C, a test for HCV-RNA or HCV antibody is required. If the HCV antibody test is positive but HCV-RNA is not detected, indicating no current infection, the patient is eligible.
Female patients must either not be of childbearing potential or have a negative pregnancy test within 14 days before starting treatment. Women of childbearing potential must agree to use highly effective contraception methods from screening to 6 months after the last study drug administration.
Male patients who can father children must agree to use two acceptable methods of contraception during the study and for 6 months after the last study drug administration, such as a condom with spermicidal gel.
Must provide a personally signed and dated informed consent document, indicating that they have been informed of all important aspects of the study.

Who Cannot Join the Study?

Patients who do not have a diagnosis of glioblastoma cannot participate. Glioblastoma is a type of brain cancer.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had a recent major surgery or are planning to have surgery during the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who have a history of certain severe medical conditions cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	30.11.2024
Italy	Not yet recruiting	30.11.2024

Trial locations

Investigated drugs:

L19TNF is a medication being studied for its potential to help treat glioblastoma, a type of brain cancer. It is designed to target and bind to specific proteins in the body, which may help the immune system attack cancer cells more effectively. In this trial, researchers are trying to find the best way to use L19TNF in combination with another medication to improve treatment outcomes for patients with glioblastoma that has returned or is getting worse.

Lomustine is a type of chemotherapy drug that is used to treat brain tumors, including glioblastoma. It works by interfering with the DNA of cancer cells, which can stop them from growing and dividing. In this clinical trial, lomustine is being used alongside L19TNF to see if the combination can be more effective in treating glioblastoma than using either treatment alone. The goal is to find the best combination that provides the most benefit to patients while minimizing side effects.

Investigated diseases:

Glioma

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. The disease typically begins with symptoms such as headaches, seizures, and neurological deficits, depending on the tumor’s location. As it progresses, glioblastoma can cause increased pressure within the skull, leading to more severe symptoms like nausea, vomiting, and changes in mental status. The tumor’s growth can disrupt normal brain function, affecting movement, speech, and cognition. Glioblastoma is characterized by its tendency to recur even after initial treatment.

Trial ID:

2024-515609-25-00

Protocol code:

PH-L19TNFLOM-01/23

NCT ID:

NCT06336291

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of L19TNF and Lomustine for Patients with Recurrent or Progressive Glioblastoma

What is this study about?

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