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
Contact

Kelly Reid, CVT
Senior Research Study Technician
[email protected]
612-625-7645

Category:
Cancer/Oncology
Species:
Dog
Current status: Open and enrolling

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 must:

  • be diagnosed with oral malignant melanoma (at least stage 1) confirmed by biopsy
  • be at least one year of age
  • weigh at least 5 kg (11 lbs) in body weight
  • have normal activity level (ECOG performance score of 0-1)
  • be systemically healthy other than having melanoma
  • have liver values that do no exceed 2X upper limit of normal (from a blood test ALT, AST)
  • have no prior melanoma vaccine (ONCEPT)
  • have no pre-existing neutralizing antibodies to the AAV vaccine delivery system (will be determined with a blood test)
  • have no steroids or other immunosuppressive drugs in the previous 7 days

Procedures

  • Screening visit:  includes exam, urine collection; blood drawn which includes a test for anti-AAV titer (presence of antibodies in the blood)
  • Day -7:  includes 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:  includes blood and urine samples collected; vaccine given and then close observation of the dog for at least 2 hours
  • Day 7 and 14:  includes an exam, blood and urine samples, checking lymph node sizes, assessing appetite, behavior and energy
  • Day 28:  same as 7 and 14 above; also includes a chest X-ray and possible lymph node aspirates
  • Months 3, 5, 7, and 9:  rechecks as Day 28 above

Costs

If your dog qualifies, you will receive a $4000 credit to apply toward local therapy (surgery or radiation therapy). This credit only applies towards therapy performed at the University of Minnesota Veterinary Medical Center. You will be responsible for any costs associated with local therapy that exceeds this credit. 

The study covers all costs during visits that are associated with the study outside of the costs for the local therapy mentioned above.