Canine Immunoneurotherapeutics Trial (CANINE)
People share many things with dogs. Unfortunately, brain tumors can be one of those things.
The biological similarities between humans and dogs are more significant than the differences. We share more than our lives with our pets–our living space, our recreational activities and sometimes our food.
One Medicine is the concept that veterinary and human medicines often overlap, and that each can learn from the other to the benefit of both.
The University of Alabama at Birmingham has received NIH funding for a multi-institutional consortium, and Auburn University’s College of Veterinary Medicine is partnering with UAB to evaluate immunotherapy of these tumors.
The Canine Immunoneurotherapeutics Trial (CANINE) uses human therapies to treat and study canine brain tumors. Dogs and humans develop malignant brain tumors at about the same rate, and these tumors are biologically similar. This trial allows us to provide compassionate care to animals, advance the field of veterinary medicine and better understand the biological effects of treatment. Discovering what we have in common may just lead to a cure.
About the Trial
The current phase (year one) of this project will establish the maximum safe and effective dose of M032, the FDA-approved, clinical-grade oncolytic herpes simplex virus (HSV) that expresses IL-12 (interleukin-12).
At Auburn’s College of Veterinary Medicine, faculty in the Neurology/Neurorsurgery Service of the Bailey Small Animal Teaching Hospital will evaluate and perform surgery on dogs — most often Boston terriers, French bulldogs, and boxers — who have brain cancer, or, are suspected to have brain cancer to remove all or part of the tumor. Shortly after surgical removal and confirmation of diagnosis by the pathologist, M032 virus is infused into the tumor area. Patients are monitored overnight in the intensive care unit, then, typically discharged to home several days after surgery. Following discharge, return visits are scheduled for one, three, six, nine and 12 months for close monitoring and serial imaging.
Phase 2 of the study will proceed with the maximum safe and effective dose of virus (established in Phase 1) paired with a checkpoint inhibitor. The checkpoint inhibitor is an oral medication given to help your dog’s own immune system better identify and kill tumor cells. It will be prescribed at discharge and given by the owner daily for six weeks. All dogs in Phase 2 will receive this combination therapy.
Dogs will be followed with regular check-ups for a full year to determine how well treatment prevents tumor regrowth and extends life. The schedule and criteria for inclusion in the study are listed below so you can understand what is being measured and what will be asked of you.
Please contact the Bailey Small Animal Teaching Hospital — (334) 844-4690 — to schedule an appointment with the Neurology/Neurosurgery Service.
Your dog must meet the following requirements to be eligible for this study:
- Must have clinical and magnetic resonance imaging (MRI) findings consistent with a diagnosis of malignant glial tumor
- Must be more than six months old
- Must have life expectancy of greater than six months
- Must have an owner who understands and is willing to sign a written informed consent document
- Must not be pregnant (this will be confirmed by pregnancy test within 14 days prior to starting study treatment)
- Steroid use is allowed as long as enrolling veterinarian has no concern
Any of these will disqualify your dog:
- Must not have had chemotherapy, cytotoxic therapy, immunotherapy within six weeks prior to entering the study (six weeks for nitrosoureas), surgical resection within four weeks prior to entering the study, or experimental viral therapy or gene therapy at any time (e.g., adenovirus, retrovirus or herpes virus protocol)
- Must not have recovered from adverse events due to therapeutic interventions administered more than four weeks earlier
- Must not be receiving any other investigational agents
- Must not have history of allergic reactions attributed to compounds of similar biologic composition to M032 or to IL-12
- Must not have tumor involvement that would require ventricular, brainstem, basal ganglia or posterior fossa inoculation or access through a ventricle in order to deliver treatment
- Must not have prior history of encephalitis, multiple sclerosis or other CNS infection
- Must not have concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famcyclovir, gancyclovir, foscarnet, cidofovir)
- Must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or any other medical condition that precludes surgery
- Must not be pregnant or nursing (this is because M032 is a viral oncolytic therapy with unknown potential for harm to pups)
- Must not have known history of allergic reaction to intravenous contrast material that is not amenable to pre-treatment
- Must not have pacemakers, ferro-magnetic aneurysm clips, metal infusion pumps, metal pellets or shrapnel fragments or certain types of stents