PRO-DOX Propranolol and doxorubicin for dogs with splenic hemangiosarcoma
Amber Winter, CVT
Research Professional 2
[email protected]
612-624-1352
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
Costs
Owners are responsible for costs of surgery (splenectomy), anesthesia, initial oncology examination fee, and prescreening diagnostics (complete blood count, serum biochemical profile, coagulation profile, urinalysis, thoracic radiography, and abdominal ultrasonography). These costs are equivalent to approximately $4,890 - $5,995 for the surgery, $2,200 - $3,500 for doxorubicin chemotherapy, and $1,000-$1,900 for the prescreening diagnostics if performed at the VMC. These costs are not subject to refund if your dog is not eligible to participate.
The study will reimburse owners up to $6,500 as follows: $1,000 for the prescreen diagnostics, up to $3000 for chemotherapy and $500 for Day 54, 96, month 6, 9, 12 (up to $2,500 total for 5 visits). The study will also cover the cost of propranolol, up to $1,095, for 12 months.