Back to resultsA Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
Primary Purpose
Glioblastoma Multiforme, Astrocytoma, Gliomas, Malignant
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Toca 511 vector
Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring glioma, glioblastoma, glioblastoma multiforme, Grade IV astrocytoma, brain cancer, recurrent glioblastoma, GBM, AA, AOD, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, high grade glioma
Eligibility Criteria
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
Sites / Locations
- University of California, Los Angeles
- UCSD
- UCSF
- Henry Ford Health System
- JFK Medical Center Neuroscience Institute
- Hackensack University Medical Center
- John Theurer Cancer Center at Hackensack University
- Cleveland Clinic Foundation
- Ohio State University
- University of Pittsburgh Medical Center
- Swedish Neuroscience Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Single arm Toca 511 vector/5-FC prodrug
Outcomes
Primary Outcome Measures
Long term safety follow up
This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.
Secondary Outcome Measures
Overall survival in days from the initial Toca 511 administration on parent study to the date of death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04327011
Brief Title
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
Official Title
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
February 2011 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tocagen Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme, Astrocytoma, Gliomas, Malignant
Keywords
glioma, glioblastoma, glioblastoma multiforme, Grade IV astrocytoma, brain cancer, recurrent glioblastoma, GBM, AA, AOD, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, high grade glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Single arm Toca 511 vector/5-FC prodrug
Intervention Type
Biological
Intervention Name(s)
Toca 511 vector
Other Intervention Name(s)
vocimagene amiretrorepvec, RRV, retroviral replicating virus
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine
Other Intervention Name(s)
Extended Release 5-FC, 5-FC, 5-Fluorocytosine
Intervention Description
Toca FC is an extended-release formulation of flucytosine.
Primary Outcome Measure Information:
Title
Long term safety follow up
Description
This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.
Time Frame
From study entry up to 15 years
Secondary Outcome Measure Information:
Title
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.
Other Pre-specified Outcome Measures:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asha Das, MD
Organizational Affiliation
Tocagen Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Vogelbaum, MD, PhD, NS
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
JFK Medical Center Neuroscience Institute
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
We'll reach out to this number within 24 hrs