This is a non-randomized, open label, dose escalation proof of concept clinical study to evaluate the safety and potential efficacy of an investigational veterinary product for treatment of osteosarcoma, melanoma, transitional cell carcinoma and squamous cell carcinoma in dogs. A client-owned dog must have a cytology or biopsy confirmed diagnosis of one of the aforementioned cancers to be eligible for participation in this study. Dogs will undergo clinical screening at study site. Preliminary staging tests will include initial consultation, physical examination with target lesion (tumor) measurements, complete blood count (CBC), serum biochemical profile, thoracic radiographs, and abdominal ultrasound. Once enrolled into the study, the IVP will be administered once weekly for 6 treatments total. Dogs will be monitored as appropriate following treatment. Once the treatment course has been completed, dogs will return 2-weeks (Day 56), then 4 weeks later (Day 84) for recheck exams and tumor measurements. The total study period is 84 days. Owners will be required to report and record abnormal daily observations and complete questionnaires relating to their dog’s pain level throughout the study.
This study is fully funded. Funding includes the initial study screening, the study treatment and administration, scheduled study lab work, recheck visits and exams, and management of side effects that are thought to be directly related to participation in the study.
Dogs may be eligible if they meet the following inclusion criteria:
- ≥ 1 year of age and weigh at least 5 kg
- Have at least one measurable lesion with a longest diameter of ≥ 20 mm at screening.
- Have a VCOG Performance Score of 0 or 1 at screening.
- Prior treatment is acceptable; however a treatment washout period may apply before trial enrollment.
- Must not have another underlying disease that could affect the study objectives.
- Owner must sign informed consent.
University of Georgia
Veterinary Teaching Hospital
Athens, GA 30602
University of Wisconsin – Madison
School of Veterinary Medicine
Madison, WI 53715
Cummings School of Veterinary Medicine
North Grafton, MA 01536
Additional study sites coming soon!
If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.