Clinical trial NCT04327011: A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
Official title: A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
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
Lead sponsor: Tocagen Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Long term safety follow up
timeFrame: From study entry up to 15 years
Secondary outcomes:
measure: Overall survival in days from the initial Toca 511 administration on parent study to the date of death.
timeFrame: From initial Toca 511 administration to death of last patient alive for up to 15 years.
Other outcomes:
measure: Progression-free survival in days from the initial Toca 511 administration on parent study to confirmed disease progression or death from any cause.
timeFrame: from initial toca 511 administration to time of progression or death of any cause for up to 15 years.
measure: Objective response rate from initial dose of Toca FC from the parent protocol
timeFrame: Time from initial dose of Toca FC to death of last patient alive for up to 15 years.
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Edison
country: United States
facility: JFK Medical Center Neuroscience Institute
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
Study officials:
affiliation: Tocagen Inc.
name: Asha Das, MD
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Michael Vogelbaum, MD, PhD, NS
role: PRINCIPAL_INVESTIGATOR
References: