Clinical Investigation Center
COTC024: Defining PK (pharmacokinetics) and biological activity of systemic oncolytic VSV within a dose-schedule optimization study
Current Status: Open and enrolling
Principal Investigator: Mike Henson, DVM, PhD, DACVIM
Contacts: Dr. Henson at the Oncology Service, 612-626-8387
Amber Winter, Senior Research Study Technician: firstname.lastname@example.org, 612-624-1352
This clinical trial, led by the National Cancer Institute and Vyriad, Inc., assesses the safety and effectiveness of a cancer-killing virus (VSV-IFNβ-NIS) when given to dogs with cancer. Studies in mice, normal dogs, and in a small study of pet dogs with cancer have shown the virus to be safe at certain doses. This virus is currently being evaluated in human patients with liver cancer in an FDA-approved trial. Results of this study will be used to help design future clinical trials evaluating VSV-IFNβ-NIS in dogs with relapsed or refractory cancer.
Eligible dogs must:
- have a malignant tumor that is accessible and large enough (>1 inch in most cases) to allow samples to be collected from it for analysis (biopsies); tumors can be either newly diagnosed or recurrent and of almost any type except mast cell tumors or hemangiosarcoma
- weigh 20 kg or more (44 lbs)
- be feeling well with no significant health concerns, other than the malignancy, identified on routine diagnostic testing (blood and urine tests, x-rays, ultrasound)
- be up to date on vaccines, flea/tick prevention and internal parasite control
- not be in contact with livestock
- have stopped any drug therapies for the cancer at least two weeks prior to enrollment
- have stopped any radiation therapy for the tumor at least six weeks prior to enrollment
- Other restrictions may apply, call for details.
- Screening visit to determine eligibility to include physical exam, history, bloodwork, chest x-rays, possible abdominal ultrasound
- First day of the study (Mondays): pre-treatment physical exam, tumor measurements, blood samples, lymph node aspirates, tumor biopsies
- Second day (Tuesday): Virus administration intravenously, monitoring, blood, urine, fecal and saliva sampling
- Depending on the group to which a dog is assigned, a 2nd intravenous dose of virus may be given on the second day
- Dogs must remain in the VMC until Friday for monitoring and sampling
- Follow-up visits are necessary at the VMC on Day 8, Day 15, Day 22, and Day 29 to measure tumor response and collect samples (e.g. blood, urine, saliva, feces)
- Dogs will be anesthetized for collection of biopsy samples prior to treatment and on Day 3, Day 8 and Day 29
Costs of the study:
Owners are responsible for the cost of the screening visit and diagnostic tests. If the dog is eligible for the study, certain costs will be reimbursed. Once enrolled, the costs of the visits above are provided by the study. In addition, $1000 will be provided as a credit towards other therapy after the dog completes the study. In the event any complications arise during the study period, their management will be covered by the study funds up to $2000. This would include any unanticipated hospitalizations after the first 3-4 days of the study.
For more information, please contact Andrea Eckert (see above).