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

March 26, 2020 updated by: Tocagen Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • San Diego, California, United States, 92093
        • UCSD
      • San Francisco, California, United States, 94143
        • UCSF
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • JFK Medical Center Neuroscience Institute
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed Consent Form
  • Subject received Toca 511 in prior study.
  • Subject is willing to abide by protocol

Exclusion Criteria:

  • Subject has history of allergy or intolerance to flucytosine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
Single arm Toca 511 vector/5-FC prodrug
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
Other Names:
  • vocimagene amiretrorepvec
  • RRV
  • retroviral replicating virus
Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine
Toca FC is an extended-release formulation of flucytosine.
Other Names:
  • 5-FC
  • Extended Release 5-FC
  • 5-Fluorocytosine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term safety follow up
Time Frame: From study entry up to 15 years
This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.
From study entry up to 15 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival in days from the initial Toca 511 administration on parent study to the date of death.
Time Frame: From initial Toca 511 administration to death of last patient alive for up to 15 years.
From initial Toca 511 administration to death of last patient alive for up to 15 years.

Other Outcome Measures

Outcome Measure
Time Frame
Progression-free survival in days from the initial Toca 511 administration on parent study to confirmed disease progression or death from any cause.
Time Frame: from initial toca 511 administration to time of progression or death of any cause for up to 15 years.
from initial toca 511 administration to time of progression or death of any cause for up to 15 years.
Objective response rate from initial dose of Toca FC from the parent protocol
Time Frame: Time from initial dose of Toca FC to death of last patient alive for up to 15 years.
Time from initial dose of Toca FC to death of last patient alive for up to 15 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tocagen Inc.

Investigators

  • Principal Investigator: Michael Vogelbaum, MD, PhD, NS, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2011

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

March 26, 2020

First Posted (ACTUAL)

March 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tg 511-09-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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