Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A P1 Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered Intravenously Prior to, and Intracranially at the Time of, Subsequent Resection for
Brief Summary: This is a multicenter study evaluating the safety and tolerability of Toca 511 administered intravenously to patients with recurrent or progressive Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Subjects meeting all of the inclusion and none of the exclusion criteria will receive a portion of the total dose of Toca 511 administered as an intravenous, bolus injection, followed approximately 11 days later by the remainder of the dose injected into the walls of the resection cavity at the time of planned tumor resection. Approximately 6 weeks later, subjects will begin treatment with oral Toca FC taken every 8 hours for 7 days, and repeated every 4 weeks. All subjects enrolled in this study will be encouraged to participate in a continuation protocol that enables additional 5-FC administration and the collection of long-term safety and response data.