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Canine Appendicular Osteosarcoma: Field Efficacy Study

Clinical Trials

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Clinical Study: A Multicenter Randomized Field Efficacy Study of K9-ACV Immunotherapy Compared to Standard of Care (Carboplatin) for Treatment of Canine Appendicular Osteosarcoma


Purpose of Study:

Immunotherapy, engaging the power of the immune system against cancer, has become increasingly incorporated into oncology care. One means of activating the immune system is by using an individual’s own tumor as a vaccine. Osteosarcoma is the most common bone tumor in dogs and children, allowing it to serve as a canine model for human disease.

Michigan State University is partnering with Ardent Animal Health and the University of Minnesota to generate customized tumor vaccines for dogs. The vaccine contains a dog’s own tumor cells with a novel primary adjuvant (K9-ACV) and a novel checkpoint inhibitor (CD200AR-L).

In this trial, the Michigan State University Veterinary Medical Center (MSU VMC) will serve as one of several testing sites. All dogs will undergo amputation to remove their osteosarcoma-affected leg. Dogs with osteosarcoma will be randomly assigned to either receive standard of care chemotherapy (carboplatin), or the investigational immunotherapy (K9 ACV + CD200AR-L).

The purpose of this study is to determine if the investigational immunotherapy product, K9-ACV + CD200AR-L, can delay the progression of canine osteosarcoma as compared to standard of care chemotherapy.


Eligibility Criteria:

Inclusion criteria:

  • Dog is ≥ 1 year of age
  • Minimum weight requirement of 25 kg (55 lbs)
  • Dog is in good general health
    • No evidence of metastasis (cancerous spread)
  • Following surgery:
    • Histologic confirmation of osteosarcoma
    • Successful generation of vaccine

Exclusion criteria:

  • Prior treatment (within 30 days) with immune-modulating drugs, including (but not limited to) cyclosporine, Apoquel, Cytopoint, prednisone, etc.
  • Prior treatment (within 7 days) with NSAIDs (prior to K9-ACV immunization)
  • Any uncontrolled medical condition that is likely to be disruptive to the intent of the study
  • Dog is pregnant or likely to become pregnant during the study
  • Dog is lactating or intended for breeding during the study
  • Dog is participating in another study
  • Dog is not available for the duration of the study


Eligibility Diagnostics:

Prior to study entry, clients will be responsible for an initial consultation at MSU and to complete the following diagnostics for their dog:

  • Cytology or histopathology of tumor in question to confirm diagnosis of osteosarcoma (if not already completed)
  • Bloodwork + urinalysis ensuring adequate organ function to undergo general anesthesia (if not already completed)
  • Three-view thoracic radiographs and abdominal ultrasound at MSU for staging


Treatment:

Participation in the study will require repeated visits (until protocol completion) to the MSU VMC. After initial consultation and screening at MSU, dogs will be scheduled for surgical amputation of the affected limb with the MSU Soft Tissue Surgery Service. The affected limb will be shipped for histopathology and vaccine production. Dogs will be randomized into one of two treatment groups: standard of care/carboplatin vs. K9 ACV + CD200AR-L. Study investigators, attending clinicians, and dog owners will not be blinded to treatment group throughout study duration. Dogs will then return two weeks after surgery for their first treatments for the study. Please note: MSU study staff have no control over the treatment that each dog is assigned to.

If randomized into the carboplatin group, dogs will be evaluated every three weeks for 4 appointments initially. At these visits, physical exam, bloodwork, and treatment with carboplatin (pending bloodwork results) are to be completed. At the 3rd visit, three-view thoracic radiographs will be performed. Following completion of the 4th treatment, dogs will return to the MSU VMC at 4, 6, & 8 months following initiation of treatment for evaluation including: bloodwork, urinalysis, three view chest radiographs, and possible abdominal ultrasound.

If randomized into the K9 ACV + CD200AR-L group, dogs will be evaluated every three weeks for 3 appointments initially. At these visits, physical exam, bloodwork, and treatment with K9 ACV + CD200AR-L are to be completed. Administration will consist of several intradermal injection over 2 visits 24 hours apart. At the 3rd visit, three-view thoracic radiographs will be performed. Following completion of the 3rd treatment, dogs will return to the MSU VMC at 4, 6, & 8 months post initiation of treatment for evaluation including: bloodwork, urinalysis, three view chest radiographs, and possible abdominal ultrasound.

The study investigators will closely monitor all patients during this study. If signs of illness requiring additional hospitalization develop, if any of the exclusion criteria listed above are met at any point, or development of any adverse reactions to treatment, investigators may remove participants from the study.

Following trial completion or study withdrawal, dogs will be able to pursue any other treatment options or recommendations.


Compensation:

  • This is a funded trial. All tests and treatments associated with the trial will be covered once enrolled.
  • Surgical amputation will be partly covered (approximately a $2500 discount). Amputation must be performed at MSU VMC.
  • Complications associated with the trial will be covered. Clients are financially responsible for all treatments and diagnostics that are unrelated to the trial. Association between complications and trial treatment will be determined by the overseeing clinician and investigators.
  • Initial evaluation appointments will be charged. For dogs accepted to the study, recheck exams during clinical trial appointments will be free of cost ($60 value per visit).
  • For dogs in the carboplatin group that develop evidence of disease progression during the study period, a vaccine will be available at no additional cost for the vaccine upon completion of the trial or removal of the dog from the study.

Contact Information:

Please feel free to contact our Medical Oncology Team at (517) 353-5420 or cvm.oncoinfo@msu.edu to refer a patient or for any additional information. Referring veterinarian and client calls are welcome.