Novel therapy for canine brain tumors
"A study of the safety and effectiveness of Toca 511, a replication
competent murine leukemia virus with a cytosine deaminase gene, administered
transcranially to companion dogs with spontaneous brain tumors and followed
by oral treatment with 5 fluorocytosin"
Purpose of Study
The purpose of this study is to evaluate the safety and effectiveness
of combining gene therapy with 5-FC (an anti-fungal drug) to treat
primary brain tumors in dogs. This treatment has shown promise in mouse
brain tumors and is currently in clinical trials in humans with brain
tumors. An effective standard treatment for canine brain tumors
has not been established in veterinary medicine. Current possible
therapies include surgical removal, radiation therapy and chemotherapy,
but canine responses to these therapies have been poorly documented and
survival times have been unclear. Using gene therapy to treat brain
tumors can be beneficial because only the tumor, and not the entire
body, would receive the cancer treatment; therefore, eliminating any
systemic side effects associated with treatment.
This form of viral gene therapy may be effective in controlling the
growth of canine brain tumors and may result in a longer survival time.
The study will cover the costs of the brain biopsy procedure, viral
infusions, brain tumor removal surgery if indicated, 5-FC, routine
intensive care unit monitoring, blood work and MRI scans (approximate
Dogs enrolled in this study must have a diagnosis of a brain tumor.
They need to be deemed healthy enough, by a neurologist, to undergo
anesthesia, a brain biopsy procedure, brain surgery to remove the tumor,
viral infusions and MRI scans. Following the viral infusion, dogs
will be required to remain at WSU-VTH for at least five days. Two
to six weeks after viral infusion, each dog will either begin taking the
oral drug 5-FC or will undergo surgery to remove the tumor and then
begin taking 5-FC. Every four weeks, owners will need to give the
oral drug to their dogs for five days. For six months following
the start of 5-FC, dogs will need to return to WSU-VTH every eight weeks
for a neurologic exam, blood work and an MRI. If in the
unfortunate event that the dog dies during the study period, an autopsy
is required to confirm the cause of death.
Participating dogs will be anesthetized for the biopsy procedure and
viral infusion of the brain tumor. Immediately following these
procedures, the dog will receive an MRI scan. Once the scan is
completed, the dog will remain hospitalized at WSU-VTH for at least five
days for routine neurologic monitoring. Two to six weeks after the
viral infusion, the dog will return to WSU-VTH to either begin taking a
drug called 5-FC or undergo surgical removal of the brain tumor and then
begin taking 5-FC. For the next six months, participating dogs
will need to return to WSU-VTH every eight weeks for a neurologic exam,
blood work and an MRI.
Owners are responsible for the costs of additional hospitalization,
medications and procedures associated with unforeseen complications.
In addition, to remain in the study, owners are required to bring their
dogs back to WSU-VTH two to six weeks after viral infusion and then
every eight weeks for the following six months.
For more information please contact either Valorie Wiss, Clinical
Studies Coordinator (Office: 509-335-0798, Cell: 509-432-5345 or
email@example.com), or Dr.
Annie Chen-Allen (509-335-0711 or