Additional Field Safety Testing of Canine Osteosarcoma Vaccine, Live Listeria Vector
Craig A Clifford DVM, MS, DACVIM (Oncology)
Kate Vickery, VMD, MS, DACVIM, CVA; Christine Mullin, VMD, Diplomate ACVIM (Oncology); Kristin Kicenuik, DVM, DACVIM (Oncology)
This study is designed to collect additional safety data for Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014), which is conditionally licensed by the United States Department of Agriculture (USDA). Dogs must have undergone amputation of the affected limb and have completed chemotherapy prior to entering the study. Potential dogs are screened 1 month after completion of chemotherapy. If deemed eligible, patients are administered COV intravenously once every 3 weeks for up to 3 treatments. Patients are kept in hospital overnight following treatment for close monitoring and management of any adverse events.
- Signed Owner Informed Consent
- Client-owned dog > 1 year of age
- Body weight ≥ 2 kg
- Histopathologic or cytologic diagnosis of osteosarcoma
- Amputation of the affected limb followed by a completed chemotherapy regimen
- ECOG Performance score of 0 or 1 [0=normal activity; 1=restricted activity, decreased activity from pre‐disease status, 2= compromised, ambulatory only for vital activities, consistently defecates and urinates in acceptable areas]
- Clinically relevant abnormalities on lab work
- Evidence of pulmonary metastases on 3‐view thoracic radiographs
- Prior immunotherapeutic treatment for osteosarcoma
- Any uncontrolled medical condition (including other concurrent malignancy) that may be disruptive to the intent and objectives of the study
- Dog is pregnant, lactating or likely to become pregnant
- Dog is participating in another study
- Dog may not be available for the entire study duration
FUNDING: The majority of study related costs (i.e. lab work, radiographs, treatment administration, hospitalization fees) are the responsibility of the owner. A small amount of funding is provided toward the cost of the vaccine.
DURATION OF STUDY: Enrollment opportunities are limited and will terminate when the target enrollment is filled.
POTENTIAL BENEFITS TO VETERINARY MEDICINE: Following standard of care treatment, COV may improve disease-free interval and overall survival time in dogs with osteosarcoma.
For more information, please contact us:
Phone: (610) 296-2099
Email: [email protected]