Study of iodofalan (131I) and lomustine combination therapy compared to lomustine alone in patients with first recurrent glioblastoma

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What is this study about?

This clinical trial focuses on patients with glioblastoma, a type of brain tumor, that has returned after initial treatment. The study tests a new treatment approach combining two medications: 131I-TLX101 (given by intravenous injection) and lomustine (taken as oral capsules). The purpose is to determine if using these treatments together helps patients live longer compared to using lomustine alone.

The study has multiple parts. In the first part, researchers will determine the safest and most effective dose of the combination treatment. In the second part, some patients will receive both medications while others will receive only lomustine. The treatment involves regular doses of lomustine, while 131I-TLX101 is given through an intravenous injection. The study will track how patients respond to the treatment and monitor any side effects that may occur.

Before joining the study, patients must undergo special imaging called FET PET scan to confirm their tumor status. This scan uses a special substance that helps doctors see if the treatment might be suitable for the patient. Throughout the study, patients will have regular check-ups, including blood tests, physical examinations, and quality of life assessments to monitor their health and response to treatment.

1 Initial treatment phase

You will receive two types of treatment: TLX101-Tx (given through a vein) and lomustine (taken by mouth)

Your treatment will be divided into different parts to ensure safety and find the right dose

Your doctor will monitor how your body responds to the treatment through regular health checks

2 Health monitoring

Regular physical examinations will be performed

Blood tests will be taken to check your blood cell counts, liver function, and kidney function

Your heart activity will be monitored through ECG (heart rhythm test)

You will complete quality of life questionnaires about your symptoms and how you feel

3 Imaging tests

You will have regular brain scans (MRI) to check how your tumor is responding to treatment

Special scans called SPECT imaging will be done to measure how the treatment is distributed in your body

Additional scans called PET will be performed to examine tumor activity

4 Treatment monitoring

Blood and urine samples will be collected to measure treatment levels in your body

Side effects will be tracked and recorded using a standardized rating system

Your neurological symptoms will be regularly assessed

5 Follow-up period

After completing treatment, you will continue to have regular check-ups

Brain scans will be performed to monitor your condition

The study will continue until late 2027

Who Can Join the Study?

Age 18 years or older
Confirmed diagnosis of glioblastoma (a type of brain tumor) that has come back after initial treatment
Evidence of tumor recurrence shown on brain scans at least 3 months after completing radiation therapy
Must have specific tumor markers visible on special brain imaging called FET PET scan
Must be able to perform daily activities independently or with minimal assistance (ECOG score 0-2 or KPS score 70 or higher)
Must have adequate blood test results including:
- Platelet count of at least 100,000 per microliter
- White blood cell count of at least 1,500 per microliter
- Hemoglobin level above 10 g/dL without recent blood transfusions
Must have normal or mildly abnormal liver function tests
Must have adequate kidney function
For women who can become pregnant:
- Must have a negative pregnancy test
- Must not be breastfeeding
- Must use effective birth control during treatment and for 6 months after
For men:
- Must use condoms during treatment and for 3 months after
- Must not donate sperm during treatment and for 6 months after
Must be able to understand and follow study requirements
If taking steroids, the dose must be stable for at least 7 days before starting the study

Who Cannot Join the Study?

Prior diagnosis of any cancer other than glioblastoma within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in-situ
History of severe allergic reactions to medications or contrast agents
Pregnant or breastfeeding women
Active, uncontrolled infections requiring treatment
Significant heart problems including heart failure, unstable heart rhythm, or recent heart attack (within 6 months)
Severe liver problems or abnormal liver function tests
Severe kidney problems or abnormal kidney function tests
Uncontrolled high blood pressure
Major surgery within 4 weeks before starting the study
Participation in another clinical trial within 4 weeks before this study
Unable to undergo MRI (magnetic resonance imaging) scans
History of bleeding in the brain
Current use of blood thinners that cannot be safely stopped
Mental conditions that could interfere with following study procedures
Known HIV (human immunodeficiency virus) infection or active hepatitis

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
CHU de Liege	Liege	Belgium
Medical University Of Vienna	Vienna	Austria
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Rigshospitalet	Copenhagen	Denmark
Caffxkafv Uqobcmelvlxtqi Sntyilpuw	Woluwe-Saint-Lambert	Belgium
Jqkfmaaa Kaexcx Ugogalfgpy	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	06.10.2025
Belgium	Not yet recruiting	06.10.2025
Denmark	Not yet recruiting	06.10.2025
The Netherlands	Recruiting	06.10.2025

Trial locations

Investigated drugs:

Iodofalan (131I) is a radioactive medication administered through injection. It is designed to target and treat brain tumors, specifically recurrent glioblastoma. This medication works by delivering targeted radiation therapy directly to cancer cells.

Lomustine is an oral chemotherapy medication used to treat brain tumors. It belongs to a group of drugs called alkylating agents, which work by stopping or slowing the growth of cancer cells. It is commonly used in the treatment of glioblastoma and other brain cancers.

TLX101-Tx is the investigational name for the Iodofalan (131I) solution for injection. This targeted radiation therapy is being studied both alone and in combination with lomustine to determine if it can improve survival rates for patients with recurrent glioblastoma.

Investigated diseases:

Glioblastoma

Glioblastoma – A type of brain cancer that forms from glial cells, which normally support and protect nerve cells in the brain. It is characterized by fast-growing tumors that develop in the brain’s supportive tissue. The disease typically causes symptoms such as headaches, nausea, vomiting, and seizures as the tumor grows and creates pressure within the brain. Glioblastoma can also cause changes in mental function, mood, or personality, depending on which part of the brain is affected. The tumor can affect different parts of the brain, leading to various neurological symptoms such as weakness on one side of the body, memory problems, or speech difficulties.

Trial ID:

2025-521785-10-00

Protocol code:

131I-TLX-101-003

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of iodofalan (131I) and lomustine combination therapy compared to lomustine alone in patients with first recurrent glioblastoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?