Multicenter Evaluation in Patients With MEningiomas of the Response to Treatment With 177LUTEtium-oxodotreotide

Meningioma Clinical Trial

— MELUTE  

Official title:

Multicenter Evaluation in Patients With MEningiomas Expressing Somatostatin Type 2 Receptors and After Failure of Standard Treatments, of the Response to Treatment With 177LUTEtium-oxodotreotide

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06255249
• Other study ID #: 2023PI224
• Status: Not yet recruiting
• Start date: July 30, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2024
• Source: Central Hospital, Nancy, France
• Contact: CAROLINE BOURSIER, MD
• Phone: 0383154039
• Email: c.boursier[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Meningiomas are the most common primary tumors of the central nervous system, representing more than a third of tumors.Current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory regardless of their grade. Some meningiomas express somatostatin type 2 receptors and can be treated with lutathera. This study aims to evaluate the response to treatment in this pathology

Description:

In nuclear medicine, peptide receptor radionuclide therapy with 177Lu-oxodotreotide, deploys an octreotide-like effect and appears very promising, with a preliminary progression free survival at 6 months of 94% and overall survival at 12 months of 88% in grade 1 meningiomas, and 28% with an overall survival at 12 months of 65% in grades 2 and 3 meningiomas. These results are nevertheless the result of a meta-analysis obtained from series of patients limited in number and heterogeneous in terms of type of treatment modality.

At the request of healthcare professionals and in consultation with the Advanced Accelerator Applications laboratory, the Agency of the drug security has developed a compassionate prescribing framework aimed at securing the use of Lutathera in meningiomas of all grades, expressing type 2 somatostatin in imaging of nuclear medicine, after failure of the standard treatment (surgery, radiotherapy/radio-surgery) or impossibility of carrying it out (multiple lesions, inaccessible lesions), at the suggestion of the national comitee OMEGA (April 6, 2022). This cohort has the advantage of being consistent and homogeneous in terms of type of treatment and method of administration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients who have benefited from treatment with Lutathera® within the framework of compassionate prescription in a refractory meningioma of any grade

• Patient informed via an information and non-opposition to the use of their pseudonymized data for research purposes (research objectives clearly explained in the letters)

Exclusion Criteria:

-Patient opposition to the use of their data for this research

Related Conditions & MeSH terms

• Meningioma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the response to treatment with Lutathera® in patients with meningioma expressing somatostatin type 2 receptors, and after failure of standard treatments, for whom compassionate access to this treatment has been requested.	Progression-free survival at 6 months (according to RANO criteria)	6 months
Primary	To evaluate the response to treatment with Lutathera® in patients with meningioma expressing somatostatin type 2 receptors, and after failure of standard treatments, for whom compassionate access to this treatment has been requested.	Overall survival at 12 months (according to RANO criteria)	12 months