Ethos PUSH01 and PUSH02
Ethos PUSH Biospecimen Collection Agreement Ethos-PUSH-01 and Ethos-PUSH-02
Purpose of study
Canine splenic hemangiosarcoma is an aggressive cancer with limited treatment options available. Standard of care for dogs with a bleeding tumor of the spleen is surgery to remove the spleen (splenectomy). Roughly 40% of the time, the disease is benign and surgery alone is enough. Many of the remaining dogs will have hemangiosarcoma as the cause of their bleeding and will require chemotherapy to delay or prevent metastatic disease. The combination of surgery and chemotherapy has been shown to provide a median survival time of 4-9 months, with only a small percentage of dogs living 2 years. Ethos-PUSH seeks to improve the outcome of canine hemangiosarcoma by furthering our understanding of this disease. Dogs with confirmed hemangiosarcoma will be randomized to receive 1 of 4 treatments. These treatments include standard and new therapies chosen using previous genetic research. Tumor and blood samples will be analyzed and saved to provide for new collaborations to better understand this disease and to develop better treatments.
- Dogs with blood in the abdomen (hemoperitoneum) and a confirmed splenic tumor are eligible to enroll in Ethos-PUSH01.
- Eligible dogs will be those able to be scheduled for surgery at the Veterinary Medical Center during normal business hours (emergency or after hours will not be able to enroll due to sampling requirements)
- Following surgery, dogs with confirmed hemangiosarcoma will be eligible to enroll in Ethos-PUSH02, the randomized chemotherapy treatment group portion of the study
- Blood tests, chest X-rays and abdominal ultrasound will confirm dogs healthy enough to undergo anesthesia
- Blood and stool study sample collection prior to surgery
- Standard of care splenectomy, with biopsy of other organs as indicated
- Following biopsy results (about 3-5 days), owners whose dogs have confirmed hemangiosarcoma will have an appointment to go over Ethos PUSH02 with their VMC veterinarian
- Randomization to 1 of 4 treatment groups:
- Doxorubicin chemotherapy (IV)
- Rapamycin (oral) in combination with doxorubicin (IV)
- Sorafenib (oral) in combination with doxorubicin (IV)
- Oral Paclitaxel
- Timing of visits to the clinic will vary depending upon the group. Oral medications will be given at home, while doxorubicin will be given in the clinic.
- Visits continue up to one year
The study pays a $1,000 stipend to assist in the costs of surgery. Dogs which enroll in Ethos PUSH02, will have their chemotherapy costs covered, plus the required study visits, blood and urine tests, and staging diagnostics (chest X-ray, abdominal ultrasound). Adverse complications of the study drugs are covered up to $3,000 if care is received at the Veterinary Medical Center.