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Study of Lutetium (177Lu) Oxodotreotide for Patients with Recurrent Meningioma Without Surgery or Radiotherapy Options

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as recurrent meningioma, which is a type of brain tumor that has returned after treatment and cannot be treated with surgery or radiotherapy. The study is investigating the use of a treatment called [177Lu]Lu-DOTATATE, also known as Lutathera, to see if it can effectively reduce the size of these tumors. Lutathera is a solution that is given through an IV infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to determine if Lutathera can provide enough benefit to justify further research. Participants in the study will receive either Lutathera or a placebo. The study will monitor the participants over a period to see how the treatment affects the tumor's growth and the patient's overall health. The study will also look at how the treatment impacts the patient's quality of life, including aspects like cognitive and social functioning, as well as fatigue levels.

Throughout the study, participants will undergo regular MRI scans to assess the tumor's response to the treatment. The study will also evaluate the safety and tolerability of Lutathera, ensuring that any side effects are carefully monitored. The ultimate goal is to see if Lutathera can help patients live longer without the tumor growing, which is referred to as progression-free survival. This study is an important step in exploring new treatment options for those with recurrent meningioma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, you will provide written informed consent, confirming your understanding and agreement to participate in the trial.

    You will undergo a series of tests to confirm eligibility, including a pregnancy test if applicable, and assessments of your medical history and current health status.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted, which includes a cranial MRI to measure the size of your tumor and a PET scan to confirm somatostatin receptor positivity.

    Your liver, kidney, and blood functions will be evaluated to ensure they are within acceptable limits.

  3. Step 3

    Treatment initiation

    The treatment involves receiving [177Lu]Lu-DOTATATE through an IV infusion. The frequency and duration of the treatment will be determined by the study protocol.

    You may also receive other medications such as bevacizumab, hydroxycarbamide, octreotide acetate, everolimus, or sunitinib as part of the study, depending on your specific treatment plan.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor your health and the tumor's response to treatment. This includes MRI scans and blood tests.

    Your quality of life and neurological function will also be evaluated periodically to assess any changes from the baseline.

  5. Step 5

    End of treatment

    At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the treatment.

    You will be monitored for any side effects or changes in your health status.

  6. Step 6

    Follow-up

    After completing the treatment, follow-up visits will be scheduled to continue monitoring your health and any long-term effects of the treatment.

    These visits will help assess the progression-free survival and overall survival rates as part of the study's objectives.

Who can join the trial?

14 criteria

  • Must be an adult aged 18 years or older.
  • If you can have children, you should use effective birth control during the study and for at least 7 months after the last treatment. Effective birth control means methods that are very reliable when used correctly.
  • If you are a breastfeeding woman, you should stop nursing before starting the study treatment and continue not to breastfeed for 7 months after the last treatment.
  • You need to provide written informed consent before joining the study. This means you agree to participate after understanding the study details.
  • You must have a confirmed diagnosis of meningioma, which is a type of brain tumor. All grades (1-3) are eligible.
  • Your WHO performance status should be between 0-2. This is a scale that measures your ability to perform daily activities.
  • You need to have a measurable tumor on a brain MRI scan, which should be done no more than two weeks before joining the study. The tumor should be at least 10 x 10 mm in size.
  • Your tumor should show progression (growth of more than 25% in the last two years) or new tumors should have appeared.
  • Your tumor must be somatostatin receptor-positive, confirmed by a PET scan. This means the tumor has certain receptors that can be detected by a special imaging test.
  • You should have had at least one surgery and one round of radiotherapy for your meningioma, if possible.
  • You need to have adequate liver, kidney, and blood function within four weeks before joining the study. This means your organs are working well enough to participate.
  • Your electrolyte levels (such as potassium, magnesium, and calcium) should be within normal limits or corrected to be normal before starting the study treatment. Electrolytes are minerals in your blood that are important for your body’s functions.
  • If you are taking corticosteroids like dexamethasone, you should be on a dose of 4 mg/day or less for at least 7 days before starting the study treatment. Corticosteroids are medications used to reduce inflammation.
  • If you are a woman who can have children, you must have a negative pregnancy test within 72 hours before joining the study. This ensures you are not pregnant before starting the treatment.

Who cannot join the trial?

10 criteria

  • Patients who have had any other type of cancer treatment recently.
  • Patients with other serious health conditions that are not well controlled.
  • Patients who are pregnant or breastfeeding.
  • Patients who have allergies to the study medication or similar drugs.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of certain mental health conditions that might affect their ability to participate.
  • Patients who have had a major surgery recently.
  • Patients with certain infections that are not well controlled.
  • Patients who are taking medications that might interfere with the study treatment.
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Investigated drugs

[177Lu]Lu-DOTATATE is a type of targeted therapy used in this clinical trial. It is designed to treat a type of brain tumor called meningioma, which can come back after initial treatment. This therapy works by delivering a small amount of radiation directly to the tumor cells. The radiation helps to damage and kill the cancer cells, while minimizing harm to the surrounding healthy tissue. The goal of using this therapy in the trial is to see if it can effectively reduce the size of the tumor or slow its growth, making it a potential option for further treatment in the future.

What is already known about the treatment

[177Lu]Lu-DOTATATE – This medication is administered through an injection, typically given by a healthcare professional. It is currently being studied in clinical trials for its potential to treat recurrent meningioma, a type of brain tumor, especially when surgery or radiotherapy are not viable options. The main therapeutic use of [177Lu]Lu-DOTATATE is to target and reduce tumor growth. At the molecular level, it works by binding to specific receptors on the tumor cells, delivering radiation directly to the cancer cells to help shrink them. It is classified as a radiopharmaceutical, which means it uses radioactive substances to treat diseases.

Investigated diseases

Recurrent Meningioma – Meningioma is a type of tumor that arises from the meninges, the membranes that surround the brain and spinal cord. Recurrent meningioma refers to the return of this tumor after initial treatment, such as surgery or radiotherapy. These tumors can vary in their growth rate, with some remaining stable for long periods while others may grow more rapidly. As they grow, they can cause symptoms by pressing on the brain or spinal cord, leading to headaches, seizures, or neurological deficits. The progression of recurrent meningioma can be unpredictable, and it may require ongoing monitoring to assess changes in size or symptoms. The lack of local treatment options in recurrent cases can complicate management and necessitate alternative therapeutic strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513443-93-00Protocol codeEORTC 2334-BTGEstimated enrolment106 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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