A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
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|ClinicalTrials.gov Identifier: NCT04327011|
Recruitment Status : Terminated (Sponsor decision)
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme Astrocytoma Gliomas, Malignant||Biological: Toca 511 vector Drug: Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511|
|Actual Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
Single arm Toca 511 vector/5-FC prodrug
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.
- Long term safety follow up [ Time Frame: From study entry up to 15 years ]This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.
- Overall survival in days from the initial Toca 511 administration on parent study to the date of death. [ Time Frame: From initial Toca 511 administration to death of last patient alive for up to 15 years. ]
- Progression-free survival in days from the initial Toca 511 administration on parent study to confirmed disease progression or death from any cause. [ Time Frame: from initial toca 511 administration to time of progression or death of any cause for up to 15 years. ]
- Objective response rate from initial dose of Toca FC from the parent protocol [ Time Frame: Time from initial dose of Toca FC to death of last patient alive for up to 15 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327011
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|San Diego, California, United States, 92093|
|San Francisco, California, United States, 94143|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, New Jersey|
|JFK Medical Center Neuroscience Institute|
|Edison, New Jersey, United States, 08820|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|John Theurer Cancer Center at Hackensack University|
|Hackensack, New Jersey, United States, 07601|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Washington|
|Swedish Neuroscience Institute|
|Seattle, Washington, United States, 98122|
|Study Director:||Asha Das, MD||Tocagen Inc.|
|Principal Investigator:||Michael Vogelbaum, MD, PhD, NS||The Cleveland Clinic|