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Evaluation of the addition of Everolimus to 177Lu-DOTATATE in the treatment of grades 2 and 3 refractory meningioma: a phase IIb clinical trial
EU CTIS ID: 2023-508400-38-00
What this study is testing
To evaluate the efficacy of combining everolimus-PRRT with 177Lu-DOTATATE on PFS-6 in grades 2 and 3 refractory meningioma.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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).
You likely can't join if
- • Hypersensitivity to everolimus
- • 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.
See the full eligibility 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.
- • Hypersensitivity to everolimus
- • 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.
- Patient receiving any systemic treatment for meningioma (bevacizumab, everolimus, cold octreotide, sunitinib, hydroxycarbamide)
- • 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
- • 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.
- • 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.