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New treatment option for Meningioma
Official title Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial
ClinicalTrials.gov ID: NCT06126588
What this study is testing
What is Everolimus?
Everolimus is an investigational medicine, being studied as a potential treatment for meningioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
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
You likely can't join if
- Hypersensitivity to everolimus.
- Contraindication to 177Lu-DOTATATE: renal failure GFR\ 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...
- If everolimus is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride...
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 177Lu-DOTATATE: renal failure GFR\ 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...
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Vandœuvre-lès-Nancy, Grand Est, France
- Vandœuvre-lès-Nancy, France
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vandœuvre-lès-Nancy, Grand Est, France; Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.