Click here to download the study flyer
Purpose and Brief Explanation of Study:
Bone cancer, or osteosarcoma (OSA), is a common, highly aggressive cancer that frequently affects the long bones of large breed dogs. Current therapy consists of limb amputation plus chemotherapy. However, despite therapy, most patients die as a result of the cancer spreading to other parts of their bodies. The immune system plays an important role in identifying and targeting cancer cells in the body.
In this study, we aim to use a new approach to stimulate the body’s own immune system to attack remaining tumor cells in dogs that have undergone standard of care limb amputation and chemotherapy for the treatment of OSA. We will use a vaccine made from the bacteria Listeria monocytogenes, which has been genetically modified to express a tumor protein (HER-2/neu) that is found in many cancer cells, including canine bone cancer cells and cancer stem cells. When injected into the bloodstream, the modified Listeria stimulates the immune system to attack cells expressing the HER-2/neu tumor protein.
This approach aims to delay and/or prevent the spread of cancer (metastasis) following removal of the primary bone cancer tumor (limb amputation) and chemotherapy.
What qualifies my dog for enrollment in this in this trial?
- Confirmed appendicular osteosarcoma which includes all long bones of the limbs (radius, humerus, ulna, scapula, femur and tibia), but excludes other bones and sites.
- No evidence of metastasis based on physical exam, thoracic radiographs, and abdominal ultrasound
- ONLY newly diagnosed dogs are eligible with no prior therapy
- Undergo standard of care treatment (amputation followed by chemotherapy) at the Ohio State Veterinary Medical Center.
What does enrolling my dog in this clinical trial involve?
As part of this study your dog will receive amputation of the affected limb. Following limb amputation your dog will return to the Ohio State University Veterinary Medical Center (OSUVMC) every 3 weeks for 15 weeks for evaluation. On weeks 3, 6, 9 and 12 your dog will receive a dose of carboplatin chemotherapy. Blood work will be done on your dog prior to carboplatin administration. After 15 completion of carboplatin chemotherapy, your dog will be administered 3 doses of the cancer vaccine ADXS31-164c. Doses will be administered every 3 weeks for a total of 3 doses. Precautions should be taken against contact with your dog’s urine or feces for 48 hours after carboplatin treatment.
Some costs associated with this study will be provided as part of your participation. In the event, any complications arise from ADXS31-164c administration, their management will be covered by study funds up to $500/per dog.
If you believe your pet may be eligible to enter this study, please click here to fill out a questionnaire.