Ongoing Clinical Trials for Meningioma
There are currently 2 ongoing clinical trials for meningioma, a type of tumor that forms on the membranes covering the brain and spinal cord. These trials are investigating new approaches to detect and treat these tumors, particularly in cases where traditional surgery or radiotherapy may not be suitable options. Trials are being conducted across several European countries, including Austria, Denmark, France, Germany, Norway, and Spain.
Clinical trial locations
- Austria
- Denmark
- France
- Germany
- Norway
- Spain
Study of Lutetium (177Lu) Oxodotreotide for Patients with Recurrent Meningioma Without Surgery or Radiotherapy Options
This clinical trial focuses on treating recurrent meningioma, which means the tumor has returned after initial treatment. The study is specifically for patients who cannot have surgery or radiotherapy as treatment options.
Who can join this trial:
- Adults aged 18 years or older with a confirmed diagnosis of meningioma of any grade
- The tumor must be measurable on a brain MRI scan (at least 10 x 10 mm in size)
- The tumor must show evidence of growth (more than 25% in the last two years) or new tumors have appeared
- The tumor must be somatostatin receptor-positive, confirmed by a PET scan
- Patients should have had at least one surgery and one round of radiotherapy previously, if possible
- Women who can have children must use effective birth control during the study and for 7 months after treatment
- Adequate liver, kidney, and blood function is required
- If taking corticosteroids like dexamethasone, the dose must be 4 mg/day or less for at least 7 days before treatment
Who cannot join this trial:
- Patients who have had other types of cancer treatment recently
- Patients with other serious, uncontrolled health conditions
- Pregnant or breastfeeding women
- Patients with allergies to the study medication or similar drugs
- Patients unable to follow study procedures or attend visits
- Patients who have participated in another clinical trial recently
- Patients who have had major surgery recently
- Patients with certain uncontrolled infections or mental health conditions
What this trial aims to achieve:
The study is investigating whether Lutathera, a targeted therapy that delivers small amounts of radiation directly to tumor cells, can effectively reduce tumor size or slow its growth. The medication is given through an IV infusion. Participants will receive either Lutathera or a placebo and will be monitored with regular MRI scans. The trial will also evaluate how the treatment impacts quality of life, including cognitive and social functioning, as well as fatigue levels. The main goal is to determine if patients can live longer without the tumor growing, which is called progression-free survival.
Investigational drug:
The study uses [177Lu]Lu-DOTATATE (also known as Lutathera), a type of targeted therapy designed to deliver radiation directly to tumor cells. It works by binding to specific receptors on the tumor cells, helping to damage and kill cancer cells while minimizing harm to surrounding healthy tissue.
Study of FG001 for Detecting Meningioma or Low-Grade Glioma in Patients Undergoing Neurosurgery
This clinical trial is studying a special imaging agent called FG001 that helps doctors see brain tumors more clearly during surgery. The study includes patients with meningioma or low-grade glioma who are scheduled for surgery to remove the tumor.
Who can join this trial:
- Adults aged 18 years or older
- A primary brain tumor visible on MRI that looks like a meningioma or presumed low-grade glioma
- Scheduled for brain surgery to remove cancer tissue
- Able to understand and sign a written consent form
- Women who can have children must agree to use reliable birth control during the study and for 30 days after
- Men must agree to use a condom during the study and for 30 days after
- Must not have taken FG001 before
- Normal functioning of organs and bone marrow, and suitable for surgery
Who cannot join this trial:
- Patients not diagnosed with a meningioma or glioma
- Patients outside the specified age range
- Patients who are part of vulnerable populations requiring special protection
What this trial aims to achieve:
The study evaluates how well FG001 can help detect brain tumors during surgery. Participants receive a single dose of FG001 through an intravenous infusion before their scheduled surgery. The imaging agent is designed to make tumor tissue more visible, making it easier for surgeons to locate and remove the tumors more accurately. The trial also monitors the safety and any side effects of using FG001 during the surgical procedure. The effectiveness of FG001 in highlighting tumor tissue is assessed using histology, which involves examining tissue samples under a microscope.
Investigational drug:
The study uses FG001, an optical imaging agent that helps locate meningiomas or presumed low-grade gliomas during neurosurgery. It works by binding to specific tumor cells, making them more visible under certain imaging techniques during surgery.
Summary
The two ongoing clinical trials for meningioma represent different approaches to managing this condition. One trial focuses on treatment of recurrent tumors using targeted radiotherapy when surgery or radiotherapy are no longer options, while the other focuses on improving surgical outcomes through better tumor detection during surgery.
The first trial is available across multiple European countries including Austria, France, Germany, Norway, and Spain, offering broader access to patients with recurrent disease. The second trial is currently only available in Denmark and focuses on the surgical phase of treatment.
Both trials use investigational agents that are administered intravenously. The treatments target different stages of disease management: one addresses tumors that have returned after initial treatment, while the other aims to improve the precision of surgical removal during initial or subsequent operations.
