Study on Everolimus and Lutetium (177Lu) Oxodotreotide for Treating Grades 2 and 3 Refractory Meningioma in Patients

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What is this study about?

This clinical trial is focused on studying a type of brain tumor called meningioma, specifically grades 2 and 3, which are more challenging to treat. The study is exploring the effectiveness of combining two treatments: Everolimus, a medication taken as a tablet, and 177Lu-DOTATATE, also known as Lutathera, which is given as an infusion directly into the bloodstream. The purpose of the study is to see if this combination can help control the growth of the tumor in patients whose meningioma has not responded to other treatments.

Participants in the study will receive the treatments over a period of several months. Everolimus is taken orally, meaning it is swallowed as a pill, while 177Lu-DOTATATE is administered through an intravenous infusion, which means it is delivered directly into a vein. The study will monitor how the tumor responds to this combination of treatments and will also track any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The trial aims to provide valuable information on whether adding Everolimus to 177Lu-DOTATATE can improve outcomes for patients with these specific types of meningioma. Throughout the study, participants will undergo regular check-ups and imaging tests, such as MRI scans, to assess the tumor’s response to the treatment. The study is expected to continue for several years to gather comprehensive data on the effectiveness and safety of this treatment approach.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a brain MRI, and a 68Ga-DOTATOC PET scan to evaluate the presence of somatostatin receptors.

Eligibility criteria include being an adult under 80 years old, having a grade 2 or 3 meningioma not suitable for surgery or radiotherapy, and showing clinical or radiological progression.

2 treatment cycle 1

The first treatment cycle begins with the administration of Lutathera (lutetium (177lu) oxodotreotide) as a solution for infusion. This is given intravenously.

In addition, Everolimus tablets are taken orally. The dosage and frequency are determined by the study protocol.

3 monitoring and evaluation

After the first cycle, monitoring includes skull scans with 177Lu-DOTATATE SPECT-CT on days 1 and 7 to calculate the dose delivered to the tumor.

Regular assessments are conducted to monitor tumor growth rate and any adverse events. These assessments follow the Common Terminology Criteria for Adverse Events (CTCAE) classification.

4 subsequent treatment cycles

Additional treatment cycles with Lutathera and Everolimus are administered as per the study schedule.

The frequency and duration of these cycles are determined by the study protocol and the patient’s response to treatment.

5 follow-up assessments

Follow-up assessments include evaluating overall survival and quality of life using the EORTC QLQ-C30 questionnaire at specified intervals.

The primary endpoint is progression-free survival at 6 months (PFS-6), assessed according to the RANO criteria.

6 end of trial

The trial is estimated to conclude by May 2028. Final assessments will be conducted to evaluate the long-term efficacy and safety of the treatment.

Who Can Join the Study?

Adult patient under 80 years old who has been fully informed about the trial and has signed the consent form.
Eligible for a special access program for treatment, as determined by a national board of neuro-oncology experts.
Has a WHO performance status of 3 or less, which is a scale that measures how well a patient can perform daily activities.
Has grade 2 or 3 meningioma, confirmed by a tissue sample, that cannot be treated with surgery or radiation, and is showing signs of getting worse.
Shows clinical decline or at least 10% tumor growth within 6 months, measured by the size of the tumor.
Has somatostatin receptors on the tumor, as shown by a special scan called 68Ga-DOTATOC PET, which helps to see if the tumor absorbs a certain substance.
Has had a brain MRI and 68Ga-DOTATOC PET scan in the last 2 months.
Women of childbearing age must use effective birth control.
Has social security coverage.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Iybvaugz Rlgnsvfa Db Cvubtd Dp Mlfwfrsuioh	Montpellier	France
Avsuujcagu Ppztcjvj Hqwemxar Dq Mupvnlhab	Marseille	France
Clsryg Hiayewdksua Rgxqxgwc Uzzjnfgajrfvr Do Tzyau	Tours	France
Chpi Dz Nmuti	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2024

Trial locations

Investigated drugs:

Everolimus is a medication used in this trial to help treat certain types of brain tumors called meningiomas. It works by blocking a specific protein that helps cancer cells grow, which may slow down or stop the growth of the tumor.

177Lu-DOTATATE is a type of targeted radiation therapy used in this trial. It delivers radiation directly to the tumor cells, which can help to shrink the tumor or slow its growth. This therapy is often used for treating certain types of tumors that have specific receptors on their surface.

Meningioma – Meningioma is a type of tumor that develops from the meninges, the protective membranes covering the brain and spinal cord. It is typically a slow-growing tumor and is often benign, meaning it is not cancerous. However, some meningiomas can be atypical or malignant, which means they can grow more aggressively. The progression of meningioma can lead to symptoms such as headaches, vision problems, or seizures, depending on its size and location. As the tumor grows, it may exert pressure on the brain or spinal cord, leading to neurological symptoms. Meningiomas are more common in older adults and are more frequently diagnosed in women than in men.

Trial ID:

2023-508400-38-00

Protocol code:

2021PI203

NCT ID:

NCT06126588

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Everolimus and Lutetium (177Lu) Oxodotreotide for Treating Grades 2 and 3 Refractory Meningioma in Patients

What is this study about?

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