Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with grades 2 and 3 refractory meningioma, which is a type of brain tumor. The trial is testing a combination of two medications: Everolimus and 177Lu-DOTATATE. Traditional treatments like surgery and radiation may not work for everyone, especially for those whose tumors have progressed despite previous treatments. The goal of this study is to see if this combination can help patients live longer without their tumors getting worse.

To participate in this trial, you need to be an adult under 80 years old with a confirmed diagnosis of grade 2 or 3 meningioma that cannot be treated with surgery or radiation. You should also have experienced some growth in your tumor recently. Participants will receive the new treatment and will be monitored closely for any side effects and how well the treatment works over a 12-month period. If you're considering joining this trial, it's important to talk with your doctor about whether this might be a good option for you.

Gender

ALL

Eligibility criteria

• 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