Everolimus for Meningioma (WHO grade 2)|Meningioma (WHO grade 3)|Refractory meningioma

Inclusion criteria

• {"criterion_text":"- •\tAdult patient < 80 years old, who received a complete comprehensive briefing about the trial and signed the informed consent\n- •\tEligible patient for compassional access program (National Multidisciplinary Neuro-Oncology board to Lutathera ® traitement\n- •\tWHO performance status ≤ 3\n- •\tPatient with grade 2 and 3 meningioma, substantiated by histology, not amenable to surgery or radiotherapy, with clinical or radiological progression\n- •\tClinical deterioration or at least 10% of tumor growth rate, defined as the product of the two largest diameters of the target lesion within 6 months\n- •\tExpressing somatostatin receptors as determined by 68Ga-DOTATOC PET (lesion uptake ≥ liver uptake and/or 1.7 fold SUVpeak of the controlateral meninges).\n- •\tPatient that underwent a brain MRI and 68Ga-DOTATOC PET within the last 2 months.\n- •\tEffective contraception required for women of childbearing age.\n- •\tPatient with social security cover."}

Exclusion criteria

• {"criterion_text":"- •\tHypersensitivity to everolimus\n- •\tContraindication to MRI or 68Ga-DOTATOC PET/CT.\n- •\tPerson referred to and L. 3212-1 and L. 3213-1 (psychiatric care).\n- •\tWomen of childbearing age without effective contraception\n- •\tPatient unable to attend follow-ups over a 12-month period\n- •\tPatients who participate in an interventional clinical research trial for the duration of the ELUMEN study.\n- Patient receiving any systemic treatment for meningioma (bevacizumab, everolimus, cold octreotide, sunitinib, hydroxycarbamide)\n- •\tIndividuals referred to in Articles 10, 31, 32, 33 and 34 of Regulation (EU) No 536/2014.\n- •\tPregnant woman, birthing or breastfeeding mother\n- •\tMinor (not emancipated)\n- •\tAdult subject to a legal protection measure (such as guardianship, conservatorship)\n- •\tAdult who is unable to give consent\n- •\tContraindication to 177Lu-DOTATATE: renal failure GFR<40 mL/min/1.73m2 (calculated by the CKD-Epi Formula), hepatic failure total bilirubin >3N, heart failure NYHA III or IV.\n- •\tCo-administration with potent inhibitors and inducers of CYP3A4 and/or the multidrug efflux pump P-glycoprotein (PgP) : Ketoconazole , itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin, Nefazodone, Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir.\n- •\tIf everolimus is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride, quinidine or ergot alkaloid derivatives), the patient should be monitored for undesirable effects described in the product information of the orally administered CYP3A4 substrate."}

Primary endpoints

• {"endpoint_text":"- PFS-6 from the start of treatment according to the RANO criteria","definition_or_measurement_approach":"Progression-free survival at 6 months (PFS-6) measured from start of treatment assessed according to the RANO criteria."}

Secondary endpoints

• {"endpoint_text":"- 1)\tOS-12. Overall Survival, defined as the time from the date of first administration of Luthatera to the date of death from any cause.","definition_or_measurement_approach":"Overall survival measured from date of first administration of Lutathera to date of death from any cause (OS-12)."}
• {"endpoint_text":"- 2)\tTumor growth rate, defined as the product of the two largest diameters of the target lesion from the MRI at M3 or M6 compared to the diameters of the lesion at baseline.","definition_or_measurement_approach":"Tumor growth rate = product of the two largest diameters of the target lesion on MRI at Month 3 or Month 6 compared to baseline measurements."}
• {"endpoint_text":"- 3)\tPFS-6. Dose delivered to the tumor (dosimetry) will be calculated on at least 2 skull scans with 177Lu-DOTATATE SPECT-CT (D1 and D7), after the first cycle of 177Lu-DOTATATE.","definition_or_measurement_approach":"Tumor dosimetry: dose delivered to tumor calculated from at least two skull SPECT-CT scans (day 1 and day 7) after the first cycle of 177Lu-DOTATATE."}
• {"endpoint_text":"- 4)\tOS-12. Dose delivered to the tumor (dosimetry) will be calculated on at least 2 skull scans with 177Lu-DOTATATE SPECT-CT (D1 and D7), after the first cycle of 177Lu-DOTATATE.","definition_or_measurement_approach":"Tumor dosimetry for OS-12 assessment calculated from at least two skull SPECT-CT scans (day 1 and day 7) after first cycle."}
• {"endpoint_text":"- 5)\tNumber and types of grade 1, 2, 3 or 4 adverse events according to the CTCAE (Common Terminology Criteria for Adverse Events) classification per patient, from the start of treatment until 180 days after the end of the last treatment cycle.","definition_or_measurement_approach":"Safety: count and categorisation of AEs per CTCAE grades 1–4 from treatment start until 180 days after end of last treatment cycle."}
• {"endpoint_text":"- 6)\tHRQoL, assessed using the EORTC QLQ-C30 questionnaire at inclusion (V1) and 6 months after Luthatera first administration (V8)","definition_or_measurement_approach":"Health-related quality of life measured with EORTC QLQ-C30 at baseline (visit 1) and at 6 months after first Lutathera administration (visit 8)."}

France

Earliest CTIS Part Ii Submission Date

11-04-2024

Latest Decision Or Authorization Date

19-02-2026

Processing Time Days

679

Number Of Sites

12

Number Of Participants

28

Primary sponsor

Full Name

CHRU De Nancy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France