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Brief Title: Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial)
Official Title: Regorafenib for Recurrent Grade 2 and 3 Meningioma. A Multicenter, Randomized Phase II Study (MIRAGE Trial)
Study ID: NCT06275919
Brief Summary: The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent grade II or III meningiomas. Small trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome. Regorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas. Noteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\<0.05) for Regorafenib treated mice. Moreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Forlì-Cesena, Italy
Humanitas Cancer Center, Rozzano, Milano, Italy
Ospedale San Paolo, Bari, , Italy
Ospedale Bellaria - AUSL Bologna, Bologna, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
Policlinico San Martino, Genova, , Italy
Spedali Riuniti, Livorno, , Italy
Azienda Ospedaliero Universitaria G. Martino, Messina, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Ospedale del Mare, Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy
IRCCS Istituto Tumori Regina Elena, Roma, , Italy
Policlinico Umberto I - Università Sapienza Roma, Roma, , Italy
A.O.U. Città della Salute e della Scienza di Torino, Torino, , Italy
Name: Giuseppe Lombardi, MD
Affiliation: Istituto Oncologico Veneto IOV IRCCS
Role: PRINCIPAL_INVESTIGATOR