Trial for dogs with bone tumors (osteosarcoma)
Evaluation of safety and effectiveness of adjuvant oral rapamycin following standard of care therapy in dogs with osteosarcoma (OSA)
Purpose and Brief Study Description:
This is a National Cancer Institute (NCI) trial sponsored by the Morris Animal Foundation for dogs diagnosed with osteosarcoma. Standard of care therapy is defined as surgical amputation of the affected limb, followed by four doses of intravenous carboplatin chemotherapy (one dose given every 21 days). Carboplatin has been safely and effectively used to treat appendicular OSA in dogs for over 20 years, but there is potential for life-threatening side effects from surgery, chemotherapy, and/or cancer progression. All dogs enrolled into this study will receive standard of care therapy. Through a randomization process, some dogs will also receive oral rapamycin after standard of care therapy.
Rapamycin is a drug currently approved to induce immunosuppression in human patients receiving organ and bone marrow transplants. Previous work suggests that rapamycin might also have anti-cancer properties by inhibiting mTOR, an important cancer pathway. Previous studies in mice, in addition to work with rapamycin analog drugs in human patients, suggest that mTOR inhibition might be effective in the treatment of several types of cancers.
To evaluate if orally administered rapamycin, following standard of care therapy, improves long-term disease control in dogs with appendicular osteosarcoma.
Prior to entry into this study, your dog must have histologically or cytologically confirmed diagnosis of osteosarcoma and staging tests to ensure his/her general health. ONLY newly diagnosed dogs, ≥25kg in size, are eligible. 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.
What does enrollment into this trial involve?
To enroll in this study, you must sign informed consent allowing the surgical amputation of your dog’s affected limb. Following amputation, your dog will return to the VHC every 3 weeks for 15 weeks for evaluation. On weeks 3, 6, 9 and 12 your dog will receive a dose of carboplatin. Precautions should be taken against contact with your dog’s urine or feces for 48 hours after carboplatin treatment. Blood work will be done on your dog prior to carboplatin administration.
After completion of standard of care therapy, and depending upon initial study randomization, you might be required to administer oral rapamycin at home for 4 months. The schedule for rapamycin administration will be daily on Monday-Thursday (4 days on), with a drug holiday on Friday, Saturday and Sunday (no dosing, 3 days off). This will allow us to determine if oral rapamycin can be safely administered chronically and will require serial collections of blood on scheduled reevaluations to allow for measurements of rapamycin within your dog’s blood. Your dog will have a total of five 24-hour serial blood draws completed over the course of 4 months. At the end of the each study cycle (Day 25), your dog must return to the VHC for reassessment and further blood collections. If your dog has been randomized to receive oral rapamycin, these visits are required for inclusion in the study. If your dog is in the Standard of Care arm only, you will be required to return to the VHC every 8 weeks for evaluation.
Following determination of your dog’s eligibility and limb amputation, costs associated with this study will be provided, including a $1000 hospital credit towards your dog’s limb amputation surgery. In the event any complications arise during the study period while rapamycin is being administered (4 months), your dog’s management will be covered by study funds up to $2000.00. This would include any unanticipated hospitalizations.
Please contact Misty Bear, Clinical Trials Coordinator, for more information. Phone: (785)532-3046; email: ClinicalTrials@vet.k-state.edu