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 one of the veterinary sites dogs undergo surgical removal of all or part of their tumor. Shortly after surgical removal and confirmation of diagnosis by the pathologist, M032 virus is infused into the tumor bed. Patients are monitored overnight in the intensive care unit. They are typically discharged to home several days after surgery. Following discharge to home, return visits are scheduled for 1, 3, 6, 9 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 given daily for six weeks. All dogs in Phase 2 will receive this combination therapy.

All 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. We believe that this is a mutual commitment to explore a promising therapy and we truly hope offer benefit to you and your pet.

Please contact your veterinarian or one of the veterinary neurosurgeons at the study site nearest you to better understand the goals, risks, benefits and alternatives available.

Inclusion Criteria

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 6 months old
  • Must have life expectancy of greater than 6 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 concerns

Exclusion Criteria

Any of these will disqualify your dog:

  • Must not have had chemotherapy, cytotoxic therapy, immunotherapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas), surgical resection within 4 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 4 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 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 implants, metal infusion pumps, metal pellets or shrapnel fragments or certain types of stents

If your pet meets the above criteria, please contact one of our veterinarians to discuss enrolling.