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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04327011
• Other study ID #: Tg 511-09-01
• Status: Terminated
• Phase: Phase 1
• Start date: February 2011
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: Tocagen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme
• Glioma
• Gliomas, Malignant

Intervention

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

Drug:
• Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine
Toca FC is an extended-release formulation of flucytosine.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	JFK Medical Center Neuroscience Institute	Edison	New Jersey
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	John Theurer Cancer Center at Hackensack University	Hackensack	New Jersey
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	UCSD	San Diego	California
United States	UCSF	San Francisco	California
United States	Swedish Neuroscience Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Tocagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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	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.