Ongoing Clinical Trials for Malignant Meningioma
There are currently 2 ongoing clinical trials investigating new treatment options for malignant meningioma, specifically focusing on grades 2 and 3 tumors that have not responded to standard treatments. These studies are exploring targeted therapies and combinations of medications that may help slow tumor growth in patients who have exhausted conventional treatment options. One trial is being conducted in France and another in Italy.
Clinical trial locations
- France
- Italy
Study on Everolimus and Lutetium (177Lu) Oxodotreotide for Treating Grades 2 and 3 Refractory Meningioma in Patients
This trial is investigating a combination treatment approach for patients with grades 2 and 3 meningiomas that have not responded to previous treatments. The study combines two medications: Everolimus, taken as a tablet, and 177Lu-DOTATATE (also called Lutathera), delivered through an infusion into the bloodstream.
Who can participate: The trial is looking for adults under 80 years old who have grade 2 or 3 meningioma that cannot be treated with surgery or radiation and is showing signs of getting worse. Participants must show either clinical decline or at least 10% tumor growth within 6 months. The tumor must have somatostatin receptors, which is confirmed through a special scan called 68Ga-DOTATOC PET. Other requirements include having a performance status of 3 or less on the WHO scale, having had a recent brain MRI and 68Ga-DOTATOC PET scan within the last 2 months, and having social security coverage. Women who can become pregnant must use effective birth control.
Who cannot participate: Patients whose tumors do not have somatostatin receptors or who do not meet the tumor growth criteria are not eligible for this study.
Treatment approach: Everolimus works by blocking a specific protein that helps cancer cells grow, potentially slowing down or stopping tumor growth. The 177Lu-DOTATATE delivers targeted radiation directly to tumor cells, which can help shrink the tumor or slow its progression. This therapy targets specific receptors on the tumor surface. Throughout the study, participants will undergo regular check-ups and MRI scans to assess how the tumor responds to treatment. Some participants may receive a placebo to compare with the actual treatment effects. The trial will monitor tumor growth rates and track any side effects that occur.
The study is expected to continue until May 2028 and aims to evaluate progression-free survival at 6 months as its primary goal, while also assessing overall survival and quality of life using standardized questionnaires.
Study on Regorafenib for Patients with Recurrent Grade 2 and 3 Meningioma After Surgery and Radiotherapy
This clinical trial is examining whether Regorafenib (also known as Stivarga) can help slow disease progression in patients with grades 2 and 3 meningiomas that have returned after surgery and radiation therapy. Regorafenib is a multi-kinase inhibitor, which means it blocks certain proteins that help cancer cells grow.
Who can participate: The study is recruiting adults 18 years and older who have a confirmed diagnosis of grade 2 or grade 3 meningioma according to WHO 2021 classification. Participants must have tumors that show growth or new lesions on imaging tests within the last 6 months and must not be eligible for additional surgery or radiotherapy. They need to have at least one measurable tumor lesion on MRI scan and a performance status of 0 to 1 on the ECOG scale, which measures the ability to perform daily activities. Participants must have adequate heart, liver, kidney, and blood function, with specific requirements for blood cell counts, liver enzymes, kidney markers, and blood clotting tests. They should have a life expectancy of at least 6 months and be able to take oral medication. If taking steroids like dexamethasone, the dose must be 4 mg or less per day and stable or decreasing for 7 days before starting the study. Tumor tissue must be available for testing. Both men and women of reproductive age must agree to use effective birth control during the study and for 6 months after the last dose.
Who cannot participate: Patients who have not had surgery and radiotherapy for their meningioma cannot join the study. Those with other types of tumors or cancers, not specifically grade 2 or 3 meningioma, are excluded. Patients unable to follow study procedures or attend required visits, those with severe medical conditions like uncontrolled high blood pressure or heart problems, and those who are pregnant or breastfeeding cannot participate. Patients participating in another clinical trial at the same time, those who have had allergic reactions to the study medication or similar drugs in the past, and those with a history of drug or alcohol abuse that could affect study participation are also excluded.
Treatment approach: Participants will be randomly assigned to receive either Regorafenib or a placebo in the form of film-coated tablets. The maximum daily dose of Regorafenib is 160 milligrams, and treatment can last up to 18 months. Regorafenib works by inhibiting multiple protein kinases involved in tumor growth and the formation of new blood vessels that supply the tumor. Throughout the study, participants will have regular follow-up visits to monitor disease progression and any side effects from the medication. Quality of life will be assessed using specific questionnaires designed for cancer patients.
The main goal is to determine if Regorafenib can extend the time patients live without their disease getting worse, known as progression-free survival. The study will also examine overall survival and tumor response to treatment. The trial is expected to conclude by the end of 2026.
Summary
Both ongoing trials for malignant meningioma are focusing on grades 2 and 3 tumors that have proven difficult to treat with conventional approaches. The studies are being conducted in different European countries—France and Italy—and are investigating distinct treatment strategies. One trial explores a combination of oral and intravenous therapies, while the other examines a single oral medication. Both studies share common features including careful patient selection based on tumor characteristics, previous treatment history, and overall health status. The trials emphasize the importance of measurable tumor lesions and documented disease progression as entry criteria. Treatment duration varies between the studies, with monitoring periods extending from 6 months to several years, reflecting the chronic nature of these tumors and the need for long-term assessment of treatment effectiveness and safety.