RecruitingPHASE2INTERVENTIONAL

177Lu-DOTATATE for Recurrent Meningioma

This study is looking into a new treatment for a type of tumour called meningioma, specifically when it has come back after previous treatments like surgery or radiation. These tumours often don't have good treatment options once they return. The new treatment, called 177Lu-DOTATATE, uses a 'precision medicine' approach. This means they first use a special scan (PET scan) to see if the tumour has a specific marker that the medicine can target. If it does, the medicine then delivers a small dose of radiation directly to the tumour, aiming to shrink or stop its growth. This is the first time this treatment is being compared in a randomised study for meningioma, and it could open new doors for future therapies.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

136

Start

10 Mar 2025

Estimated completion

22 Dec 2028

Recurrent Meningioma

What is this study about?

Imagine you have a small growth in your brain or around your spinal cord called a meningioma. Sometimes, even after surgery or radiation treatment, these can grow back. When this happens, doctors don't currently have many effective medications to offer. This can be a very worrying situation for patients and their families.

This study, called LUMEN-1, is exploring a new and hopeful approach using a medicine called 177Lu-DOTATATE. This medicine works a bit like a smart bomb. First, doctors do a special scan (called a PET scan) to see if your meningioma has a specific 'target' on its surface, almost like a lock on a door. If your tumour has this target, the 177Lu-DOTATATE medicine, which acts like a key, can attach to it. Once attached, it delivers a small, targeted burst of radiation directly to the tumour cells, aiming to damage them and stop their growth, while hopefully sparing healthy cells nearby.

Researchers are very keen to see if this treatment can be effective. We already know that meningiomas often have these 'targets' (called somatostatin receptors), and similar treatments have shown promise in other types of cancer. This study is the first important step to see if 177Lu-DOTATATE can become a standard treatment option for people with recurrent meningioma when other therapies haven't worked.

Key takeaways

This study is for meningioma that has come back after other treatments.
It tests a new targeted radiation medicine called 177Lu-DOTATATE.
A special scan is used to check if the tumour can be targeted by the medicine.
You will be randomly assigned to either the new medicine or standard care.
This is the first study of its kind for recurrent meningioma and could lead to new treatments.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. You must have a confirmed diagnosis of meningioma that has come back, and it needs to be visibly growing on a recent brain scan. This growth should be at least 25% bigger over the last two years, or new tumours should have appeared.

You would have already had at least one surgery and one course of radiation treatment for your meningioma. A crucial step for this study is a special scan (a PET scan) that shows your tumour has a specific 'marker' that the study medicine can target. Your general health, including your liver, kidneys, and blood counts, also needs to be good enough to safely take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has your meningioma grown back after surgery and radiation?
Does a recent scan show your tumour is growing?
Could you travel to regular hospital appointments for treatment and check-ups?
Are you generally well enough to take part in medical studies?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the new study medicine, 177Lu-DOTATATE, or the standard care that your doctor would normally recommend. This is done by chance, like flipping a coin. You'll have regular hospital visits for scans, blood tests, and to receive your treatment. Doctors will carefully monitor your health and how your tumour responds. There will also be follow-up appointments after your treatment finishes to see how you are doing in the long term. The total length of your participation will depend on how you respond to treatment and the study plan.

Potential risks and benefits

Taking part in this study might offer you a chance to receive a new treatment that isn't widely available yet, which could potentially help if your meningioma has returned and other treatments haven't worked. However, like all medicines, 177Lu-DOTATATE may have side effects, and your doctors will discuss these with you in detail. There is also no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

A.O Landeskrankenhaus - Innsbruck Universitaetsklinik
Verified postcode
Innsbruck, Austria· Recruiting
Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken
Verified postcode
Vienna, Austria· Recruiting
Centre Leon Berard
Verified postcode
Lyon, France· Recruiting
Centre Eugene Marquis
Verified postcode
Rennes, France· Recruiting
CHRU de Nancy - Hopitaux De Brabois
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting
Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
Oslo University Hospital - Radiumhospitalet
Verified postcode
Oslo, Norway· Recruiting
St Olavs University Hospital - St. Olavs Hospital, Trondheim University Hospital
Verified postcode
Trondheim, Norway· Recruiting
Vall D Hebron - Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia
Verified postcode
Barcelona, Spain· Recruiting
Hospital Universitario 12 De Octubre
Verified postcode
Madrid, Spain· Recruiting
Oncology Institute of Southern Switzerland (IOSI) - Ospedale San Giovanni
Verified postcode
Bellinzona, Switzerland· Not yet recruiting
UniversitaetsSpital Zurich - Neurology Clinic
Verified postcode
Zurich, Switzerland· Not yet recruiting

Common questions

What is a meningioma?

A meningioma is a type of tumour that grows from the layers of tissue covering the brain and spinal cord. Most are not cancerous, but they can still cause problems if they grow large.

What does 'recurrent' mean?

Recurrent means that the tumour has grown back after previous treatments like surgery or radiation.

What is 177Lu-DOTATATE?

It's a new medicine that delivers a small amount of radiation directly to tumour cells that have a specific 'target' on their surface.

What is a 'randomised trial'?

This means that participants are put into different treatment groups by chance, like drawing lots, to fairly compare the new treatment with standard care.

Will I definitely get the new treatment?

Not necessarily. Because it's a randomised study, you might receive the new medicine or the standard care, chosen by chance.

How to find out more

EORTC

eortc@eortc.org +32 2 774 16 11 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.