Listeria Vaccine for Dogs with Osteosarcoma
Evaluation of a recombinant, attenuated Listeria monocytogenes expressing a chimeric human HER2/neu protein in dogs with osteosarcoma in the adjuvant setting.
This clinical trial led by the National Cancer Institute (NCI) and sponsored by the Morris Animal Foundation evaluates the safety and effectiveness of ADXS31-164c when given to dogs with osteosarcoma after receiving standard of care treatment. Standard of Care is defined as amputation surgery, followed by 4 doses of intravenous Carboplatin chemotherapy given on a q21 day schedule.
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 limb amputation and chemotherapy for the treatment of OSA. We will use a vaccine, referred to as ADXS31-164c, 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 (metastases) following removal of the primary bone cancer tumor (limb amputation) and chemotherapy.
Dogs weighing 25kgs (55lbs) or more after amputation surgery with:
- Histologically or cytologically confirmed appendicular osteosarcoma, which includes all long bones of the limbs (radius, humerus, ulna, scapula, femur and tibia), but excludes metatarsus, metacarpus, carpal and tarsal bones, and digits.
- Measurable disease that is amenable to surgical removal via limb amputation. Amputation must be done at KSU VHC.
- No evidence of metastasis based upon physical exam, thoracic radiographs, and abdominal ultrasound
- No prior therapy (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates) for osteosarcoma is allowed. Dogs receiving analgesics including NSAIDs, gabapentin, tramadol, or other are eligible for study inclusion. Dogs receiving apoquel, cytopoint or other immunoactive agents may be included if they have a three week washout period prior to study enrollment.
What does enrollment into this trial involve?
Within this study, we ask that you permit surgical amputation of your dog’s affected limb. Your dog will return to KSU VHC every 3 weeks for 15 weeks for evaluation. On weeks 3, 6, 9 and 12 your dog will receive a dose of carboplatin. Blood work will be done on your dog prior to carboplatin administration.
After completion of standard of care, your dog will be administered 3 doses of ADXS31-164c. Doses will be administered every 3 weeks for a total of 3 doses. These visits are required for inclusion in the study and your dog will be required to stay overnight after receiving ADXS31-164c. After treatment, all enrolled patients will return for recheck visits every 2 months until metastatic disease is observed. Dogs that have disease progression while receiving carboplatin, or at week 15, are eligible to still receive ADXS31-164c following the same study procedures outlined above. This subset of dogs will be used to evaluate the effect of ADXS31-164c in the setting of established metastatic disease.
Once your dog has been enrolled, the study will cover the cost of the initial oncology consultation and chest radiographs, as well as most costs associated with the 3 doses of ADXS31-164c. Standard of care therapy (amputation followed by 4 doses of Carboplatin) is not covered by study funds and will be the responsibility of the owner.
For more information, please contact Misty Bear, Clinical Trials Coordinator:
Phone: (785)532-3046; E-mail: ClinicalTrials@vet.k-state.edu