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

Stopped early · Phase 1

Conditions studied: Glioblastoma Multiforme, Astrocytoma, Gliomas, Malignant

In brief

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.

Key facts

Study ID

NCT04327011

Run by

Tocagen Inc.

People needed

65

Starts

2011-02-01

Expected to finish

2019-12-01

Last updated by the study team

2020-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• UCSD — San Diego, California, United States
• UCSF — San Francisco, California, 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
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Swedish Neuroscience Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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