Feline RNA Nanoparticle Vaccine against Oral Squamous Cell Carcinoma

Enrollment Criteria: Currently Enrolling 

*PLEASE NOTE*  A definitive diagnosis is required by histopathology along with imaging (staging, e.g., radiographs, and/or CT) for screening purposes. All pets must first be evaluated by the UF Oncology service before being reviewed as study candidates. Please see the Oncology Referral Forms on our Referring Veterinarians page here and below: https://smallanimal.vethospital.ufl.edu/contact-us/referring-veterinarians/

*The appointment wait list is often booked out several weeks in advance, please note that interest in a trial does not unfortunately expedite the waiting process of being seen via the UFVH Oncology services.*

• Inclusion Criteria: Any cat diagnosed with oral squamous cell carcinoma that does not have any other major illnesses. Any definitive therapy (radiation, surgery, chemotherapy, etc.) can be pursued for these patients as part of a standard of care after a naïve tumor sample has been collected from the tumor for study vaccine creation. 
• Exclusion Criteria: Cats with advanced disease process (local and or metastatic). Cats may not have systemic comorbidities such as chronic kidney disease, diabetes, seizures, FIV+, liver disease, other cancers, etc., are not eligible for enrollment. Cats on immune modulating medications or supplements may be eligible, but only after a wash out period and approval by the study investigators.
• Treatment: The vaccine will be administered by intravenous infusion over 30 minutes. There will be 3 vaccine visits over 9 weeks. Patients will also be asked to return for recheck visits 1 month and 3 months after the final vaccine treatment. In the event of disease progression, patients may return for additional booster vaccines to continue to slow the spread of disease.
• Cost: The study will cover the cost of the 3 vaccine administration visits, including associated exam fees and pre- and post-administration bloodwork, immune monitoring, and supportive care. The cost of the 1-month and 3-month recheck visits will also be covered by the study. If a patient were to receive booster vaccines, the costs of the booster vaccine and associated administration fees will be covered by the study. Owners will be responsible for the cost of standard, recommended treatment of feline SCC. This includes but is not limited to an initial study evaluation and diagnostics; surgery, chemotherapy and radiation therapy costs.
• Contact: Please complete the Study Interest Form for more information.
• PI: Dr. Rowan Milner

Background:

Like humans, cats spontaneously develop oral tumors called squamous cell carcinomas. Squamous cell carcinoma (SCC) is a malignant cancer seen in a variety of locations in cats, including the tonsils, under or on the tongue, mouth, and esophagus. The prognosis of both human and feline patients with SCC remains poor with currently available treatment options. Because of this, there is room for research into therapies which have the potential to better treat this disease in both cats and humans. In this trial, we will use the cat’s own tumor sample to create a “personalized” RNA-NP vaccine. This is the first feline study in which the personalized ribonucleic acid nanoparticle (RNA-NP) approach is used to help the pet’s own immune system to fight this cancer.