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

NCT04327011 | Terminated Phase 1 DMC

• 1 other identifier: Tg 511-09-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Long term safety follow up

  This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.

  From study entry up to 15 years

Secondary Outcomes (1)

• Overall survival in days from the initial Toca 511 administration on parent study to the date of death.

  From initial Toca 511 administration to death of last patient alive for up to 15 years.

Other Outcomes (2)

• Progression-free survival in days from the initial Toca 511 administration on parent study to confirmed disease progression or death from any cause.

  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 from initial dose of Toca FC to death of last patient alive for up to 15 years.

Study Arms (1)

Experimental

EXPERIMENTAL

Single arm Toca 511 vector/5-FC prodrug

Biological: Toca 511 vector; Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine

Interventions

Toca 511 vector BIOLOGICAL

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

Also known as: vocimagene amiretrorepvec, RRV, retroviral replicating virus

Experimental

Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine DRUG

Toca FC is an extended-release formulation of flucytosine.

Also known as: Extended Release 5-FC, 5-FC, 5-Fluorocytosine

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject has history of allergy or intolerance to flucytosine

Sponsors & Collaborators

• Tocagen Inc.: lead

Study Sites (11)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

UCSD

San Diego, California, 92093, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

JFK Medical Center Neuroscience Institute

Edison, New Jersey, 08820, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

John Theurer Cancer Center at Hackensack University

Hackensack, New Jersey, 07601, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Glioma; Brain Neoplasms; Oligodendroglioma

Interventions

vocimagene amiretrorepvec; Flucytosine

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Asha Das, MD

  Tocagen Inc.

  STUDY DIRECTOR

• Michael Vogelbaum, MD, PhD, NS

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: March 30, 2020
• Study Start: February 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)