Using a New Therapy for Dogs with Osteosarcoma to Delay or Prevent Metastasis
Canine osteosarcoma (OSA or bone cancer) is an aggressive cancer that frequently affects the long bones of large breed dogs. Even with chemotherapy it can cause local bone destruction and spread easily to other organs, so new therapies are needed to prevent or delay this spread and extend lives. Cornell University College of Veterinary Medicine, in conjunction with the Comparative Oncology Trials Consortium, is offering a new clinical trial to help treat dogs with OSA to evaluate the safety and effectiveness of a new vaccine following standard of care therapy. Current standard of care therapy consists of surgical limb amputation plus four doses of chemotherapy, given in a vein, every three weeks.
Because the immune system plays an important role in identifying and targeting cancer cells in the body, this study aims to use a new approach to stimulate the immune system to attack remaining tumor cells in dogs with OSA. We will use a study vaccine, which has been 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. The hope is that when injected into the bloodstream, the vaccine 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. Interactions with other drugs are unknown, so it is necessary to disclose any medications (and supplements) your dog is currently taking to the oncologist. It is strongly encouraged to eliminate all unnecessary medications.
**Please note that all staging diagnostics (including but not limited to radiographs, ultrasound, and blood work) must be performed at Cornell University in Ithaca, NY prior to surgery and chemotherapy. Full amputation surgery within 10 days of the initial staging diagnostics, as well as all chemotherapy and vaccine administration appointments must also be performed at Cornell. Please contact the clinical trials coordinator for more information.
ELIGIBILITY: Dogs greater than 50 pounds after amputation surgery with histological or cytological confirmation appendicular osteosarcoma, which includes all long bones of the limbs (radius, ulna, humerus, scapula, femur and tibia) PRIOR to amputation. Dogs must have measurable disease (limb cannot be amputated prior to enrolling in the study) that is amendable to surgical removal via amputation and no evidence of metastasis on physical exam, thoracic radiographs, and abdominal ultrasound. Dogs must be newly diagnosed without prior therapy (conventional or metronomic chemotherapy, ionizing radiation, or bisphosphonates.) Dogs must not have significant co-morbid illness (including but not limited to renal or hepatic failure, history of congestive heart failure, or clinical coagulopathy) and certain blood work parameters must be met.
COMPENSATION: The cost of the vaccine is covered by the study. All other costs, including the initial staging, surgery, chemotherapy, and vaccine monitoring are the responsibility of the owner. The owner is responsible for the initial office visit, staging diagnostics to determine eligibility, as well as the cost of amputation surgery. Owners must return to Cornell for follow-up appointments, chemotherapy and investigational drug visits. The owner is also responsible for any post-chemotherapy blood work tests.
OWNER RESPONSIBILITY: All appointments including surgery must be performed at the Cornell Animal Hospital. Owners are responsible to bring patients to all study visits at the set schedule. All costs, with the exception of the cost of the study vaccine only, are the responsibility of the owner.
Principal Investigator: Cheryl Balkman, DVM, DACVIM