Trial closed August 2022.
Patient Disease:
Canine Osteosarcoma
Study Name:
COTC030: Evaluation of Inhaled recombinant-human IL-15 combined with Standard-of-Care in Dogs with Osteosarcoma
Purpose of the study:
- To determine whether inhaled recombinant-human IL-15 (rhIL-15) therapy is effective at delaying the onset of metastasis in dogs with OSA when combined with standard-of-care (definitive surgery and subsequent chemotherapy) while evaluating its safety and tolerability in the post-operative/ pre-chemotherapy setting
Primary Eligibility Criteria:
- Histologically or cytologically confirmed diagnosis of osteosarcoma of the leg for which owners plan to pursue amputation
- Adequate blood work
- No prior treatment with chemotherapy, radiation therapy, or bisphosphonates
- No evidence of metastatic disease
- Pets must come to CSU for all visits related to the clinical trial
Study Protocol:
- Dogs undergo surgical limb amputation
- Following amputation, dogs receive inhaled rhIL-15 twice daily for 14 days
- After completion of rhIL-15 treatment, dogs will receive carboplatin chemotherapy given every 3 weeks for 4 treatments
- Following chemotherapy, dogs will recheck every two months for chest x-rays
- Blood samples are collected at several visits throughout the trial for study purposes
Owner Responsibilities:
- You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist
- You are responsible for the costs associated with limb amputation and carboplatin chemotherapy including treatment of side effects related to chemotherapy as well as the exam fees for the recheck visits
- You are expected to make and keep all appointments associated with the study
- You must be comfortable treating your dog with the inhaled rhIL-15 (we will provide training on how to do this)
Financial Incentives:
- All costs associated with the rhIL-15 treatment will be covered by the study
- The study will also cover the cost of chest x-rays done throughout the study
If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.