A Phase 1 interventional study of Toca 511 vector and Toca FC in Glioblastoma, Anaplastic Astrocytoma and Anaplastic Oligodendroglioma, sponsored by Tocagen Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-21.
Sponsored by Tocagen Inc. · Phase 1, Interventional, and Treatment
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 54 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Tocagen Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Toca 511 vector/ Toca FC prodrug
Biological: Toca 511 vector · Drug: Toca FC
Single, stereotactic, transcranial, intratumoral injection or intravenous injection
Also known as: Retroviral Replicating Vector (RRV), Gene Therapy, Gene Transfer
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.
Also known as: flucytosine, 5-FC, 5-FC XR, Toca FC (extended release flucytosine)
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
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tocagen Inc.