New vaccine for dogs with oral melanoma

australian setter close-up
Principal Investigator
Antonella Borgatti, DVM, MS, Dipl. ACVIM (Oncology), Dipl. ECVIM-CA
Professor, Oncology, Veterinary Clinical Sciences
Category:
Cancer/Oncology
Species:
Dog
Current status: Ongoing but enrollment closed

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.