Tg511-11-01: A Phase 1 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 and Followed by Treatment with Toca FC, Extended-Release 5-FC

Cancer - Brain
Principal Investigator: Tommy Mikkelsen, MD

This is a multicenter study evaluating the safety and tolerability of Toca 511, a retroviral replicating vector, injected into the resection cavity of patients with recurrent or progressive Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 5 weeks after the administration of Toca 511, subjects will receive oral Toca FC, an antifungal drug, every 4 weeks.

  1. Is the subject between 18 and 80 years old inclusive?
  2. Has the subject undergone at least one prior surgical gross-total or subtotal tumor resection and a course of postoperative radiation therapy with concurrent temozolomide?
  3. Does the subject have a single tumor recurrence/progression that is < or = 6 cm in its greatest dimension?
Tiffany Pearce
(313) 916-1784