METeOR - Dogs with osteosarcoma or soft tissue sarcomas
A novel approach combining oncolytic virotherapy and dual immune checkpoint blockade for metastatic and inoperable sarcomas
Purpose of study
Osteosarcoma is the most common bone tumor found in the dog. While we can manage the primary disease with surgery and chemotherapy, the disease in most dogs will eventually spread to other organs, most commonly the lungs. Soft tissue sarcomas are another common tumor found in dogs and develop from the connective tissues that holds organs together. It can invade deep within the tissue making it difficult or impossible to remove by surgery. In order to improve survival in patients without increasing morbidity, newer safe and effective therapies are needed. In this study, we are evaluating a new combination therapy using a genetically modified Vesicular Stomatitis Virus (VSV-IFNß-NIS, or "VSV") plus a new molecule that increases anti-tumor immunity, called onco-immune accelerator or "ONIx".
- have a diagnosis of recurrent or inoperable sarcoma of any type (soft tissue or osteo)
- weigh minimum of 16.5 lbs (7.5 kg); dogs larger than 110 lbs (50 kg) will be accepted on a case by case basis
- be spayed or neutered
- be feeling well with no significant health concerns other than it’s sarcoma
- be up to date on vaccines, flea/tick prevention and internal parasite control
- not be taking alternative or herbal medications (washout period of 1 week prior to enrollment)
- not be housed near or otherwise have access to livestock (VSV is a concern in livestock)
- discontinue prednisone or other immunosuppressive drugs for two weeks prior to enrolling in the study (if removing immunosuppressive drugs would be life-threatening, the dog would not be eligible)
The visits for the study include (summary):
- Screening with exam, blood and urine collection, and CT scan of the chest and abdomen with biopsy if tissue is available
- Week 1: Monday – Friday dogs will stay in the Veterinary Medical Center to receive treatment with VSV (given IV), ONIx (given under the skin) and observation. Dogs will receive VSV on Monday and Tuesday, then ONIx on Wednesday and Friday. Dogs can go home on Friday after a 2-hour observation period post-ONIx treatment. Samples of blood, urine, and saliva will be collected.
- Recheck visits with ONIx treatments on Day 7, 28, 49, 70, and samples of blood and urine . Dogs will stay a minimum of two hours post-treatment for observation, owners can drop off the dogs for their convenience.
- Restaging visits on Day 49, 98, 182 for CT scans of the chest and abdomen, plus biopsy if tissue is available, samples of blood and urine
Owners pay for the initial diagnostic exam, bloodwork and urinalysis at the screening appointment (cost to owners approximately $495 - $555). The study covers all costs of study-related procedures up to a maximum of $10,620. Owners also cover costs to manage their dog's disease beyond the study procedures.