Tg511-08-01: A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511 in Patients With Recurrent High Grade Glioma

Cancer - Brain
Principal Investigator: Tommy Mikkelsen, MD

This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of increasing, single doses of Toca 511, a Retroviral Replicating Vector (RRV), administered transcranially to subjects with recurrent high grade glioma (rHGG) who have undergone surgery, radiation therapy and chemotherapy with temozolomide. Approximately 4 weeks following the injection of Toca 511, treatment with oral Toca FC, an antifungal drug, will commence for 7 days and be repeated every 4 weeks for 6 cycles.

  • At least 18 years of age
  • Single, supratentorial HGG (WHO grade III or IV) less than or equal to 9 cm^2 in its greatest cross sectional area
  • At least one surgical gross-total or subtotal resection
  • Postoperative radiation with concurrent temozolomide
Tiffany Pearce
(313) 916-1784