Andrew J. Brenner MD, Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECTâ„¢ clinical trial speaks about Rhenium-186 NanoLiposome (186RNL) from its ReSPECTâ„¢ clinical trial in recurrent glioblastoma (GBM).
Design of the Study:
• A multi-center, open-label, dose-escalation study assessing the safety, tolerability, and distribution of 186RNL through intrathecal infusion to the ventricle in patients with LM after routine surgical, radiation, and/or chemotherapy treatment.
• With a starting dose of 6.6 mCi in a volume of 5 mL, a modified Fibonacci dose escalation was used, followed by an expansion at the MTD, to test efficacy.
• The incidence and severity of adverse events (AE) as well as dose-limiting toxicities are the primary objectives (DLT)
• Overall response rate (ORR), duration of response (DoR), Progression-free survival (PFS), and overall survival (OS) are secondary goals (OS)
• The pharmacokinetic and dosimetry profile of a single dose of 186RNL delivered intraventricularly through the Ommaya reservoir are exploratory objectives.