Canine RNA-Nanoparticle Vaccine Combined with Anti-PD1 Drug Against Osteosarcoma for Canine Patients with and Without Metastatic Disease (Currently Enrolling)

Canine RNA-nanoparticle Vaccine Against Osteosarcoma for Canine Patients with and Without Metastatic Disease

The University of Florida College of Veterinary Medicine is currently recruiting dogs recently diagnosed with appendicular osteosarcoma for a clinical research trial.  This investigational trial is for the development of a vaccine for the future treatment of appendicular osteosarcoma in dogs.

Enrollment Status: Currently Enrolling 

Inclusion Criteria: Dogs that have been diagnosed with osteosarcoma of a limb based on microscopic confirmation following biopsy and or amputation. Tissue from your dog’s tumor will be collected as a part of a biopsy or amputation surgery at the University of Florida Veterinary Hospitals. A piece of the tumor obtained during the standard of care amputation will be used for the RNA-nanoparticle cancer vaccine creation. Your dog may also qualify for the study if they forgo amputation, but instead receive radiation therapy. They must receive a core biopsy prior to radiation for vaccine production. This will be done under anesthesia during the radiation planning CT, no additional sedation or anesthesia will be required.

Treatment: RNA Study Vaccine and anti PD1 drug administration will take place by an IV infusion over approximately 30 minutes. After each vaccine administration, your dog will be monitored in the hospital for anywhere from 6-24 hours post vaccine. Your dog will also have routine bloodwork checked at each visit, and chest x-rays, as well as abdominal ultrasound to track disease progression. Additional blood samples will be collected to monitor immune response to the vaccine as well. Lastly, your veterinary oncologist may recommend further diagnostics at the initial consultation and periodically throughout the trial to monitor your dog’s health.

Cost: The client is responsible for the cost of “standard of care” treatment of canine osteosarcoma (initial evaluation and diagnostics, imaging, bloodwork, and surgery). Estimates will be given to you, the owner, during the initial veterinary oncology evaluation and any other visits that are not covered by the study. The “standard of care” treatment estimates will be prepared for you separately by our oncology services (including the cost of amputation surgery and/or radiation).

The study will cover the cost of:

•The production of the RNA study vaccine and vaccine associated exam fees.

•Immune marker blood work during the vaccine visits.

•Safety blood chemistries and complete blood counts during vaccine visits.

•Urinalysis during vaccine visits (if recommended by the clinician).

•Some imaging associated with the study (chest x-rays and or abdominal ultrasounds).

•Adverse events which occur during vaccine administration days.

*If an immediate anaphylactic reaction (severe, life-threatening allergic reaction) occurs within I 2 hours post vaccine administration, the study will also cover a portion of the related complications treatment (up to an additional $1000).

Contact: Contact the Oncology Staff at (352) 392-2235 to schedule an evaluation or complete the Study Interest Form to see if your dog qualifies.

PI: Dr. Rowan Milner, Dr. Elias Sayour, and Dr. John Ligon

Background: Osteosarcoma is a bone cancer seen in both animals and young humans. Despite therapy that can include chemotherapy and surgery, the outcomes for humans and canines with osteosarcoma remain poor with frequent metastasis (spread) of disease. We have shown in mouse models that cancer vaccines created using genetic material from the patient’s tumor can treat cancer safely and effectively. Furthermore, the vaccine has been shown to preferentially travel to the lungs, the most common site of osteosarcoma spread. Dogs represent a naturally occurring model for immunotherapy treatment trials of osteosarcoma. There is an opportunity to better treat this often-terminal cancer by combining immunotherapy and a checkpoint inhibitor with standard of care (chemotherapy, and or surgery and or radiation).