PRO-DOX Propranolol and doxorubicin for dogs with splenic hemangiosarcoma

Yellow Labrador retriever in green field
Species:
Dog

Category:
Cancer/Oncology

Status: Ongoing but enrollment closed
Principal Investigator: 
Erin Dickerson
PhD
Antonella Borgatti
DVM, MS, DACVIM (Oncology), DECVIM-CA

Study title

PRO-DOX: Clinical evaluation of propranolol in combination with doxorubicin for the treatment of hemangiosarcoma

Purpose of study

This is a multi-site study taking place at the University of Minnesota Veterinary Medical Center, Purdue University, and University of Pennsylvania. We have shown that a drug commonly used to treat heart disease, propranolol, can kill hemangiosarcoma cells in the laboratory. The drug has also been effective in reducing disease progression and increasing the survival time in people with angiosarcoma, a cancer very similar to canine hemangiosarcoma. This study will test three dose levels of propranolol along with standard doxorubicin chemotherapy for safety and benefit to dogs with hemangiosarcoma.

Eligibility criteria

  • Have hemangiosarcoma (HSA) restricted to the spleen, which has been treated with surgical removal prior to study
  • Weigh more than 15 kg (33 lbs)
  • Have no evidence of metastasis
  • Have an adequate supply of red blood cells (>= 22% packed cell volume)
  • Are free of kidney, liver or heart disease, or problems with blood clotting
  • Cannot have received cyclophosphamide or other chemotherapy
  • Cannot have received any alternative medications as therapy for their HSA (with an exception for Yunnan baiyao or similar given only for 24 hours or less, followed by a 7 day washout)
  • May be taking prednisone and/or nonsteroidal anti-inflammatory drugs (NSAIDS) to manage other chronic conditions

Procedures

  • Screening to establish eligibility, includes chest X-ray, abdominal ultrasound, echocardiogram, blood and urine tests (X-ray, ultrasound may have been performed prior to screening)
  • Day 1 exam, blood pressure, blood sample, start on oral propranolol tablets
  • During days 4-9, study staff will work with owners and statistician to determine if the dog can move up to the next dose of propranolol
  • PK sampling post-propranolol on Day 11 (small amounts of blood taken over a 24 hour period)
  • Doxorubicin chemotherapy begins on Day 12 with PK sampling post-chemotherapy
  • Rechecks and follow up at every chemotherapy visit (Days 33, 54, 75, 96) plus at 6, 9 and 12 months