💬In plain words
What the trial is, and whether it could suit you
Meningioma, the most common intracranial primary tumor of the central nervous system predominantly affects people in their fifties. Meningiomas are generally subdivided into two entities: a priori non-aggressive meningiomas (grade 1), and meningiomas at high risk of aggressive behavior (grade 2/atypical and 3/anaplastic). The current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory irrespectively of grade, and in these rare entities, the therapeutic arsenal is reduced to the few treatments that have shown limited efficacy. Refractory, and particularly grades 2 and 3 meningiomas, have very poor prognoses with a progression-free survival at 6 months (PFS-6) of 26%. The European Response Assessment in Neuro-Oncology group (RANO) recommends that in any new, grades 2 and 3 meningioma, thera
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Adult patient \< 80 years old, who received a complete comprehensive briefing about the trial and signed the informed consent
* Eligible patient for compassional access program (National Multidisciplinary Neuro-Oncology board to Lutathera ® traitement
* WHO performance status ≤ 3
* Patient with grade 2 and 3 meningioma, substantiated by histology, not amenable to surgery or radiotherapy, with clinical or radiological progression
* Clinical 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
* Expressing somatostatin receptors as determined by 68Ga-DOTATOC PET (lesion uptake ≥ liver uptake and/or 1.7 fold SUVpeak of the controlateral meninges).
* Patient that underwent a brain MRI and 68Ga-DOTATOC PET within the last 2 months.
* Effective contraception required for women of childbearing age.
* Patient with social security cover.
Exclusion Criteria:
* Hypersensitivity to everolimus.
* Contraindication 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.
Patients should not take the following treatments:
* Other rapamycin derivatives (sirolimus, temsirolimus, deforolimus).
* Other immunosuppressants
* Co-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.
* If 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.
* Contraindication to MRI or 68Ga-DOTATOC PET/CT.
* Person referred to and L. 3212-1 and L. 3213-1 (psychiatric care).
* Women of childbearing age without effective contraception
* Patient unable to attend follow-ups over a 12-month period.
* Patients who participate in an interventional clinical research trial for the duration of the ELUMEN study.
* Individuals referred to in Articles 10, 31, 32, 33 and 34 of Regulation (EU) No 536/2014.
* Pregnant woman, birthing or breastfeeding mother
* Minor (not emancipated)
* Adult subject to a legal protection measure (such as guardianship, conservatorship)
* Adult who is unable to give consent
HealthTeky