Astrocytoma, Glioblastoma Multiforme, Gliomas, Malignant
Conditions
Keywords
glioma, glioblastoma, glioblastoma multiforme, Grade IV astrocytoma, brain cancer, recurrent glioblastoma, GBM, AA, AOD, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, high grade glioma
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.
Interventions
BIOLOGICALToca 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
DRUGToca FC • Flucytosine • 5-FC • 5-Fluorocytosine
Toca FC is an extended-release formulation of flucytosine.
Sponsors
Tocagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long term safety follow up | From study entry up to 15 years | This will be based on treatment emergent adverse events, clinical laboratory values and viral testing. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Other
| Measure | Time frame |
|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed