Local Immune Response to Radiation Therapy and Combined Myeloid Cell Targeted Therapy in a Dog Model of Sinonasal Carcinoma

Patient Disease:

Canine Sinonasal Carcinoma

Study Name:

Purpose of the study:

To investigate the local immune response following stereotactic body radiotherapy (SBRT) and determine whether concurrent administration of two immune-modulating drugs, losartan and propranolol, improves positive anti-tumor immune responses in dogs with sinonasal carcinoma

Primary Eligibility Criteria:

Dogs with a confirmed diagnosis of sinonasal carcinoma
Good function of liver and kidneys, acceptable blood cell counts, and free of severe underlying disease
No evidence of metastatic disease or extension of the tumor into the brain
No prior chemotherapy and no prior radiation to the tumor
No current treatment with immune-modulating drugs
Dogs will undergo a CT scan to confirm eligibility and for radiation planning purposes

Study Protocol:

Blood and tumor (via nasal flush) samples will be collected prior to, at the end of, and two weeks and 3 and 6 months after radiation therapy
Dogs enrolled into this study will be randomized to one of two groups: the first group will receive SBRT in combination with oral losartan and propranolol, and the other group will be treated with SBRT alone
Two weeks following the last treatment of radiotherapy, dogs will return to the hospital for a nasal flush and tumor biopsy
Three, 6, 12, and 18 months after completion of SBRT, dogs will return for blood work, urinalysis, and CT scan to evaluate tumor response to treatment

Owner Responsibilities:

Follow appointment schedule required by study protocol
Payment of the costs of the CT scan that is used for radiation planning (~$1700) as well as all other costs associated with the radiation treatment (medications, medical boarding, e-collars etc,), any other tests recommended, as well as in the case of adverse events unrelated to the study

Financial Incentives:

All costs related to radiation planning/therapy will be covered by the clinical trial (standard planning/therapy costs for this radiotherapy protocol are approximately $5000-6000)
Owners will not be charged for the additional diagnostic tests or sampling that are associated with this trial (blood work, study medications, nasal flush, tumor biopsy, additional anesthesia time) as these will be covered through the funding of the study
All costs related to the 3, 6, 12, & 18 month post-SBRT visits (including exam fee, blood work, urinalysis, and CT scan) are paid for by the study
In the case of adverse events directly related to study procedures (i.e. nasal tumor biopsy), the study will cover the costs of supportive care

If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.