Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A P1 Ascending Dose Trial of Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma & Followed by T
Brief Summary: This is a multicenter study evaluating the safety and tolerability of increasing doses of Toca 511, a retroviral replicating vector, injected into the resection cavity of subjects with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 6 weeks after injection of Toca 511, subjects will take an oral course of 5-FC, an antifungal antibiotic. These one week courses of 5-FC will be repeated during the 31 week study. In some subjects, Toca 511 and Toca FC will also be evaluated with either of the following standard treatments for glioma: lomustine, a drug approved by the FDA to treat brain tumors or bevacizumab, an alternative drug approved by the FDA to treat brain tumors. After completion of this study, all subjects will be eligible for enrollment and encouraged to be in a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.