Novel radiotherapy-immunotherapy approaches to target sarcomas in dogs
Status: Open and enrolling
Development of novel radiotherapy-immunotherapy approaches to target sarcomas
Purpose of study
The purpose of this study is to investigate how tumors and the immune system change following stereotactic body radiation therapy (SBRT), a new immunotherapy drug, or immunotherapy and SBRT. This study will help us to launch a new treatment option for dogs with sarcomas and helps us to develop a similar drug for use against human sarcoma.
- Dogs that have a biopsy-confirmed soft tissue or bone sarcoma
- Tumor that measures > 2 cm in longest diameter that is amenable to multiple biopsies
- Weigh > 7 kg (15.4 lbs)
- Good performance score (0 or 1)
- No significant co-morbidities that affect heart, lung, kidney or liver function
- Not be receiving chemotherapy, targeted therapies, immunotherapy, or other anticancer drugs (such as prednisone)
- Committed to returning to the University of Minnesota for all visits
Please note that dogs will need to be screened at the University of Minnesota prior to enrollment in the study. Minimum staging tests that will be required include complete blood count, biochemistry profile, and radiographic evaluation of the lungs. Additional tests may be needed depending on the dog’s tumor.
There are several different parts or arms of the study. Dogs will be enrolled in one of these:
1) SBRT treatment to investigate how the tumor and the dog’s immune system responds
2a) Immunotherapy drug alone to determine how dogs tolerate treatment
2b) SBRT following immunotherapy drug to examine how SBRT changes a tumor and immune system response after immunotherapy treatment
For all arms of the treatment, dogs will receive a pre-treatment tumor biopsy, blood collection, and lymph node aspirates. A biopsy will be repeated at the end of treatment with SBRT (Arm 1) or immunotherapy (Arm 2a), and several blood and lymph node samples will be collected during and after treatment.
Visits for each arm:
1) SBRT alone: 14 visits over approximately 11-12 months
2a) Immunotherapy alone: 9 visits over approximately 1 month
2b) SBRT after immunotherapy: 12 visits over approximately 6 months (after completion of 2a above)
The dog’s owner is responsible for costs associated with diagnosis and staging that permits enrollment. Once enrolled, the study will pay all expected costs associated with treatment, including all standard costs associated with SBRT and immunotherapy treatments.