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

Phase 1

Terminated

• Conditions: Gliomas, Malignant; Glioblastoma Multiforme; Astrocytoma
• Interventions: Biological: Toca 511 vector; Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine

• Registration Number: NCT04327011
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2016-12-21
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine	Single arm Toca 511 vector/5-FC prodrug
Experimental	Toca 511 vector	Single arm Toca 511 vector/5-FC prodrug

Primary Outcome Measures

Name	Time	Method
Long term safety follow up	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

Name	Time	Method
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.

Trial Locations

Locations (11)

Swedish Neuroscience Institute; 🇺🇸 Seattle, Washington, United States

UCSD; 🇺🇸 San Diego, California, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

UCSF; 🇺🇸 San Francisco, California, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

John Theurer Cancer Center at Hackensack University; 🇺🇸 Hackensack, New Jersey, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

JFK Medical Center Neuroscience Institute; 🇺🇸 Edison, New Jersey, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States