Clinical Investigation Center
VIGOR Trial: Translational approach for development of a novel oncolytic immunotherapy for osteosarcoma
Current status: Active and enrolling
Principal Investigator: Jaime Modiano, VMC, PhD
Contacts: Dr. Modiano, firstname.lastname@example.org
Andrea Eckert, Senior Research Study Technician: 612-625-3157 or email@example.com
Osteosarcoma (OSA), the most common bone tumor found in the dog, has already spread by the time we diagnose 90% of the cases. Survival times are limited, from 3-4 months with surgery alone, to 9-14 months with the addition of chemotherapy. In order to improve survival in dogs, newer therapies are needed. We are studying genetically modified Vesicular Stomatitis Virus (VSV-IFNß-NIS, called VSV for short) which has been shown to be safe in a pilot study of eight dogs, and in two separate studies totaling more than 20 pet dogs with cancer.
Dogs in this study will be chosen at random to have treatment with VSV or with a saline placebo. Neither the owners nor the investigators will know which treatment the dogs are given. Dogs given placebo will still receive the standard of care treatment of amputation and chemotherapy.
Eligible dogs will:
- be diagnosed with osteosarcoma in a limb bone
- weigh more than 44 lbs (20 kg)
- be feeling well with no significant health concerns
- be spayed or neutered
- be up-to-date on vaccines, flea/tick prevention and internal pest control
- no evidence of metastasis on chest x-ray
- have no previous chemotherapy or radiation therapy
- not be taking alternative or herbal medications
- not be near livestock (VSV is a concern in livestock)
- be willing to discontiue prednisone or other immunosuppressive drugs for two weeks prior to enrolling in the study
- Day -2 screening: exam, blood and urine collection, CT scan of the chest and abdomen to check for metastasis
- Day -1 tumor biopsy under anesthesia and baseline samples of blood, cheek, urine and stool
- Week 1: dogs will spend the week at the Veterinary Medical Center (VMC). On Day 0 (Monday or Tuesday), dogs receive treatment with VSV or placebo and will be housed in isolation, closely monitored by our team, for about 6 hours. We will sample blood, cheek, urine and stool periodically to detect virus shedding and immune responses. On Days 1-3 we will monitor the dog and take additional samples. Dogs go home on Day 3 (Thursday or Friday).
- Recheck visits weekly for first month
- Day 10 amputation occurs which is standard of care for dogs with osteosarcoma in a limb. The surgery is delayed to day 10 to give the VSV some time to do its work.
- Chemotherapy begins about Day 21, uses the drug carboplatin, scheduled through the VMC Oncology service
- Recheck visits at month 3, month 6 and one year. We will repeat the CT scan, typically at the 3 month visit.
Costs of the study:
Owners are responsible for the screening appointment and staging diagnostics prior to Day -2 to determine if their dog is a good candidate for the study. The study covers up to $8600 in care, which includes the procedures listed above and much of the dog's chemotherapy.
To enroll or learn more about the study, please contact Andrea Eckert, research study technician, or Dr. Jaime Modiano (see above).