This multi-center open label Phase II safety and efficacy study is designed to enroll up to 40 glioblastoma patients who have experienced a first relapse. The study’s primary objective is to confirm the maximum tolerated dose of Cotara in these GBM patients.
Secondary objectives include estimates of overall patient survival, progression free survival and the proportion of patients alive at six months.
Patients in the trial are receiving a single infusion of Cotara by convection-enhanced delivery (CED), an NIH-developed technique which delivers the agent to the tumor achieving up to a 10,000-fold greater concentration in local therapy exposure than conventional intravenous drug administration, while minimizing unwanted exposure to healthy tissue, according to Peregrine. This delivery method is expected to further enhance the tumor-killing potential of Cotara.