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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327011
Recruitment Status : Terminated (Sponsor decision)
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Tocagen Inc.

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.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Astrocytoma Gliomas, Malignant Biological: Toca 511 vector Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
Actual Study Start Date : February 2011
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019


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:
  • Extended Release 5-FC
  • 5-FC
  • 5-Fluorocytosine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 Outcome Measures:
  1. 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. ]
  2. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327011


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
UCSD
San Diego, California, United States, 92093
UCSF
San Francisco, California, United States, 94143
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New Jersey
JFK Medical Center Neuroscience Institute
Edison, New Jersey, United States, 08820
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
John Theurer Cancer Center at Hackensack University
Hackensack, New Jersey, United States, 07601
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Tocagen Inc.
Investigators
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Study Director: Asha Das, MD Tocagen Inc.
Principal Investigator: Michael Vogelbaum, MD, PhD, NS The Cleveland Clinic
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Responsible Party: Tocagen Inc.
ClinicalTrials.gov Identifier: NCT04327011    
Other Study ID Numbers: Tg 511-09-01
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tocagen Inc.:
glioma
glioblastoma
glioblastoma multiforme
Grade IV astrocytoma
brain cancer
recurrent glioblastoma
GBM
AA
AOD
anaplastic astrocytoma
anaplastic oligodendroglioma
anaplastic oligoastrocytoma
high grade glioma
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Flucytosine
Antifungal Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action