A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma
Status:
Completed
Trial end date:
2016-08-18
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of
increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients
with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant
radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic,
transcranial injection into their tumor or as an intravenous injection given daily for 3 & 5
days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment
with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6
weeks until study completion. After completion of this study, all patients will be eligible
for enrollment and encouraged to enter 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.