New vaccine for dogs with oral melanoma
Kelly Reid, CVT
Senior Research Study Technician
[email protected]
612-625-7645
Study title
Evaluation of a cancer vaccine for companion dogs with oral melanoma
Purpose of study
This study will assess the safety and effectiveness of a new vaccine for dogs with oral melanoma. The new vaccine is an adeno-associated virus (AAV) vaccine. Safety will be assessed with close monitoring of the dogs post-vaccination, and recheck visits for blood and urine collection and lymph node assessments.
Eligibility criteria
- Dogs diagnosed with oral malignant melanoma (at least stage 1) confirmed by biopsy
- Dog is at least one year of age
- Dog weighs at least 5 kg (11 lbs) in body weight
- Dog has normal activity level
- Dog is systemically healthy other than having melanoma
- No prior melanoma vaccine (ONCEPT)
- No pre-existing neutralizing antibodies to the AAV vaccine delivery system (will be determined with a blood test)
- No steroids or other immunosuppressive drugs in the previous 7 days
Procedures
- Screening visit with exam, blood draw, urine collection. Blood tested for anti-AAV titer (presence of antibodies in the blood). If none, the dog can proceed.
- Day -7 CT scan under anesthesia of the head, neck and chest, biopsy of tumor, lymph node aspirates
- Local therapy (surgery or radiation therapy) begins based upon the dog’s clinical condition
- Day 0 Vaccine given at the recheck following surgery or completing radiation therapy, blood and urine samples. Close observation of the dog for at least 2 hours.
- Recheck visits for exams, blood and urine samples, checking lymph node sizes, assessing appetite, behavior and energy:
- Day 7
- Day 14
- Day 28 also with chest X-ray and possible lymph node aspirates
- Months 3, 5, 7, and 9 rechecks as Day 28 above (includes chest X-ray)
Costs
Owners are responsible for the standard of care surgery or radiation therapy. The study covers costs of the visits listed.