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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Single, stereotactic, transcranial, intratumoral injection or intravenous injection
4-6 week cycles of Toca FC. Doses evaluated from 120 mg/kg/day or 300 mg/kg/day. Duration of dosing evaluated: 6 days, 7 days or 14 days.
City of Hope
Duarte, California, United States
UCLA
Los Angeles, California, United States
UCSD
San Diego, California, United States
UCSF
San Francisco, California, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Maximum Feasible, Safe and Well Tolerated Dose of Toca 511
Time frame: 8-10 weeks
Safety and tolerability of repeated treatment with Toca FC following administration of Toca 511
Review of adverse events including laboratory safety data (specifically any Grade 3 or higher non-hematologic toxicity or any Grade 4 or higher hematologic toxicity, felt to be related to Toca 511 or the Toca 511/Toca FC combination)
Time frame: 6 months
Overall survival of Subjects
Time frame: Overall survivial, Overall survivial at 6 months (OS6), 9 months (OS9), and 12 months (OS12)
Evaluate progression free survival (PFS) at 6 months
Time frame: 6 months
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