Vaccine study for Dogs with Appendicular Osteosarcoma

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: Any dog recently diagnosed with appendicular osteosarcoma that does not have other life threatening diseases and is treatment naïve. Your dog is eligible for the study when they
  have had their affected limb amputated and sampled at the University of Florida. More specific inclusion criteria will be discussed with you during your evaluation appointment. Your dog will have the vaccine in addition to standard of care therapy.
• Treatment: The vaccine will be given over 6 visits approximately 3 weeks apart in addition to 6 chemotherapy visits. If appropriate you dog will also receive boosters every 6 months. The chemotherapy visits will be scheduled 2 weeks prior to each vaccine visit. At each visit, blood will also be drawn to measure the immune response for study purposes.
• Cost: You will need to schedule an Oncology Evaluation Appointment for your dog. This evaluation appointment is a pre-requisite for determining eligibility and does not guarantee that your dog will qualify to receive the study vaccine. If your dog is eligible for the study at the time of the evaluation, all costs will be discussed with you prior to study enrollment. This study does not offer any financial incentive and all costs are the responsibility of the client. This includes the costs for the initial evaluation, amputation, and chemotherapy as well as the cost of study vaccines (6-series). Additional diagnostics as well as subsequent visit costs will also be responsibility of the client.  Complications due to the vaccine are not expected, but should any arise, the study will pay for those treatments directly associated with the injection site reaction to a maximum of $100.00. No other costs will be covered
• 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

Background:

Osteosarcoma is malignant cancer of both young humans and animals. The standard of care for humans and dogs with osteosarcoma is surgery followed by chemotherapy. Unfortunately, a large number of these osteosarcomas undergo early metastasis (spread) following surgery. This occurs even when surgery is done early and the tumor is removed in its entirety and chemotherapy is given. Infections of the osteosarcoma surgery site have been known to cause an immune reaction in people and animals improving overall survival. Since overall survival is dismal in patients with osteosarcoma, developing an osteosarcoma cancer vaccine holds promise as an adjunct treatment to surgery and chemotherapy. In a previous study of 400 dogs with melanoma we showed that a vaccine containing the ganglioside (GD3) causes a measurable immune response in normal dogs and dogs with melanoma and prolonged survival.