NCT04327011

A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Tocagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, continuation study to allow subjects who have previously received Toca 511 to continue to receive Toca FC and to allow for extended safety observations. Subjects will be seen on an every six week basis for 1 year or longer. Subjects who continue to receive Toca FC will receive the dose described in the "parent" protocol. If the Toca FC dose is adjusted for any reason, the serum concentration will be monitored. Gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scans will be performed as per standard of care. If the subject has recurred/progressed, repeat intracranial injection of Toca 511 followed by Toca FC treatment may be offered to consenting patients. Subjects who enter the study to continue Toca FC and subsequently discontinue Toca FC, and subjects who are only willing or able to perform limited testing will have viral testing alone, at the appropriate intervals. After the first year, subjects will be seen twice yearly for the next 4 years and then contacted yearly for the next 10 years. All subjects will be followed on study for at least 5 years regardless of whether they are taking Toca FC.

Conditions

• Glioblastoma Multiforme
• Astrocytoma
• Gliomas, Malignant

Interventions

Type	Name	Description
BIOLOGICAL	Toca 511 vector	Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
DRUG	Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine	Toca FC is an extended-release formulation of flucytosine.

Timeline

• Start date: 2011-02-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2020-03-30
• Last updated: 2020-03-30

Locations

11 sites across 1 country: United States