The vision “to create a world where we no longer fear cancer” drives the work of Dr. Jaime Modiano and his colleagues in the Animal Cancer Care and Research Program of the University of Minnesota College of Veterinary Medicine. The “Shine On” study represents a turning point in their efforts to achieve this vision, by finding a way to prevent hemangiosarcoma, an aggressive, malignant tumor of blood vessel cells, in dogs. To do this, Modiano’s group plans to use a test to find hemangio- sarcoma cells in the blood of dogs at risk for the disease. His group will then treat the dogs that have hemangiosarcoma cells in their blood with a new drug that kills the those cells before they ever have a chance to form a tumor.
The Milestones for Shine On became a reality thanks to funding from the Golden Retriever Foundation, American Boxer Charitable Foundation, Portuguese Water Dog Foundation, and AKC Canine Health Foundation. The study is divided into three phases, each of which represents one of the three milestones that Modiano’s group expects to achieve.
- Phase 1, the first milestone, is to confirm that testing for the presence of hemangiosarcoma cells in the blood of dogs will help distinguish dogs that have the disease from dogs that do not.
- Phase 2, the second milestone, is to determine if testing for the presence of hemangiosarcoma cells in the blood will be useful in predicting when tumors become resistant to treatment, therefore helping to predict which patients will relapse and when.
- Phase 3, the third milestone, is to find hemangiosarcoma cells in the blood at the earliest stages of the disease and to treat dogs that have these cells with a drug called eBAT to eliminate the hemangiosarcoma cells from the blood before tumors have a chance to form.
Progress and Early Results
Modiano’s team began working on the Shine On project in March 2016. A major challenge was to refine the blood test so that hemangiosarcoma cells in the blood could be detected not only in dogs with tumors, but also in dogs that had not yet developed tumors. Researchers spent the first six months investigating how to do this, identifying several molecules that they believe will improve the sensitivity and specificity of the test for early detection.
In the next six months, they made substantial progress toward the first two milestones. Modiano’s team screened blood samples from 54 dogs in Phase 1. Thirty-one dogs were unaffected and the other 23 dogs had hemangiosarcoma, another type of cancer, or a spleen mass that was due to a condition other than cancer. They defined the smallest number of hemangiosarcoma cells that the test could detect in a routine blood sample and confirmed that hemangiosarcoma cells are not detectable in the blood of otherwise healthy dogs at low risk for the disease.
Early results from Phase 2, where researchers tested samples from dogs that are undergoing treatment, suggest the patented blood test could show when a treatment might not work as well. In preparation for Phase 3, they established the safety of eBAT, a drug developed at the University of Minnesota to treat hemangiosarcoma and other cancers, in two clinical trials. They also documented the ability of eBAT to eliminate the cells responsible for initiating and maintaining hemangiosarcoma. eBAT’s remarkable safety record, potential to directly kill the cells that form hemangiosarcoma tumors, and ability to modify the cellular environment so it becomes inhospitable for tumor growth and survival make it a highly desirable drug for hemangiosarcoma prevention.
The plan is to continue enrolling dogs in Phase 1 and Phase 2 of Shine On for the duration of the study. Modiano expects enrollment for Phase 3 to begin in fall 2017. Golden retrievers, boxers, and Portuguese water dogs from the lower 48 states that are at least 6 years old and have no evidence of disease will be eligible to participate in Phase 3. Owners will receive information about how the test is done, how to interpret results, and options after testing. Complete information on eligibility and rules for participation is available on the University of Minnesota College of Veterinary Medicine Clinical Investigation Center website at http://z.umn.edu/shineon.
eBAT chemoprevention therapy will be available exclusively at the University of Minnesota Veterinary Medical Center in St. Paul, Minnesota, for eligible dogs participating in Phase 3 of the Shine On study. These dogs must have had two consecutive positive tests for hemangiosarcoma cells in the blood and have no detectable tumor. Their owners must consent to the dog’s treatment with eBAT.
Shine On represents a shift in both the way we think about cancer and the way we conduct research. The project is progressing on schedule, and Modiano’s team is optimistic, as the results so far are consistent with their predictions.