Canine RNA-Nanoparticle Vaccine Combined with Anti-PD1 Drug Against Osteosarcoma for Canine Patients (Currently Enrolling)

Canine RNA-nanoparticle Vaccine with Anti PD1 drug Against Osteosarcoma for Canine Patients

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. Cells from your dog’s tumor will be collected as a part of a biopsy at the University of Florida Veterinary Hospitals. These cells will be used for the RNA-nanoparticle cancer vaccine creation. Dogs which qualify for the study must receive radiation therapy. The core biopsy (or collection of tumor cells) must occur 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. Dogs with mild metastatic spread of the disease, may be offered admission into the trial at the investigator’s discretion.

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 imaging will be used 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 the diagnosis and treatment of the osteosarcoma which qualifies as standard of care (initial evaluation and diagnostics, imaging, bloodwork, and radiation planning/treatment). The study will cover all study vaccine related costs, and may offer some financial coverage of radiation treatment on a case by case basis. 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 treatment estimates will be prepared for you separately by our oncology services (including the cost of 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 cases will be offered financial coverage of a set of imaging and or radiation treatment itself.

•Adverse events, if they 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.

Principal Investigators: 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).