Clinical evaluation of propranolol in combination with doxorubicin for the treatment of hemangiosarcoma
Hemangiosarcoma is a type of cancer that is difficult to treat because of its aggressive behavior and rapid progression after diagnosis. 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. We will study the tolerability and clinical benefit of propranolol in combination with doxorubicin chemotherapy. Propranolol will be tested at three dose levels: 0.8 mg/kg, 1.0 mg/kg, and 1.3 mg/kg. Each of these doses is thought to be in the effective range for propranolol. The study will also determine if higher doses work more effectively with chemotherapy. Your dog will start at one of these doses and may be increased to the higher doses depending upon how your dog tolerates propranolol. We will also study the pharmacokinetics (PK) of propranolol in the blood to determine if there is a correlation between blood PK and effectiveness of the treatment. Results of this study will be shared with the veterinary community and pet owners. Results will provide new information so that we can continue to improve upon treatments for this disease.
Eligible dogs will have hemangiosarcoma restricted to the spleen which has been treated by surgical removal of the spleen (splenectomy) prior to enrollment in the study. Dogs must weigh more than 15 kg (33lbs) to be eligible for participation. Routine thoracic radiographs (chest x-rays), abdominal ultrasound, complete blood cell counts, serum chemistries, coagulation profile and urinalyses will help us determine eligibility. To be eligible, dogs must:
- Have no evidence of metastases
- Have adequate supply of red blood cells (less than or equal to 22% packed red cell volume)
- Be free of concurrent kidney, liver or heart disease, or problems with blood clotting
In addition to the requirements above, to be enrolled:
- Dogs cannot have received cyclophosphamide or other chemotherapy.
- Dogs cannot have received alternative/holistic medications or supplements.
- The use of anti-inflammatory medications (NSAIDs or prednisone) is acceptable.
Owner Responsibilities (samples and information to be collected):
- Days 0-96, (See Informed Client Consent for more details) Echocardiogram, study imaging, physical exam, blood for CBC, serum profile and coagulation profile, urine collected for urinalysis, thoracic x-ray and abdominal ultrasound. Chemotherapy following these procedures, echocardiogram if needed.
- 6-months, 9-months, 12-months: Physical exam, blood for CBC, serum profile and coagulation profile, urine collected for urinalysis, thoracic x-ray and abdominal ultrasound.
Download the Informed Consent Form for more details regarding protocol and required samples.
|Investigator||Investigator||Clinical Research Technician||CIC Research Manager|
|Brian Husbands, D.V.M.||Erin Dickerson, Ph.D.||Amber Winter||Kathy Stuebner|
To speak to someone about your rights and about your dog as a research subject, please contact the Institutional Animal Care and Use Committee: 612-626-2126.
Help Future Generations of Dogs
Participate in canine health research by providing samples or by enrolling in a clinical trial. Samples are needed from healthy dogs and dogs affected by specific diseases.