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

NCT04327011 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-03-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Tocagen Inc.

    lead INDUSTRY

Principal Investigators

  • Asha Das, MD · Tocagen Inc.

  • Michael Vogelbaum, MD, PhD, NS · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327011 on ClinicalTrials.gov