Pharmacological Tumor Microenvironment Modification with 3-Drug Combination in Canine Metastatic Osteosarcoma

Patient Disease:

Canine Osteosarcoma with Metastasis to the Lungs

Study Name:

Pharmacological Tumor Microenvironment Modification with 3-Drug Combination in Canine Metastatic Osteosarcoma

Purpose of the study:

  • To evaluate the anti-tumor effects of a 3-drug combination of toceranib (Palladia), losartan, and propranolol in dogs with metastatic osteosarcoma

Primary Eligibility Criteria:

  • Dogs that have had surgery to remove their primary tumor and a confirmed diagnosis of osteosarcoma with measureable metastatic disease in the lungs on chest X-rays
  • Adequate blood work
  • Two-week washout from chemotherapy or radiation therapy; no concurrent treatment with any immunosuppressive drugs; no prior immunotherapy for OSA
  • No metastatic disease anywhere besides the lungs
  • No pre-existing allergic airway disease or a significantly low heart rate
  • Pets must come to CSU for all visits related to the clinical trial

Study Protocol:

  • Dogs will be treated with oral losartan and propranolol to be given twice daily and oral Palladia given once every other day.
  • Rechecks will be required every 2 weeks following the start of treatment for the 1st 3 months, and every 4 weeks thereafter if tumors are stable or better
  • At the week 2 visit, your dog will need to stay in the hospital all day for serial blood collections following propranolol administration
  • Chest x-rays will be rechecked every 8 weeks while on study

Owner Responsibilities:

  • You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist
  • You are responsible for the costs of the exam fee at each study appointment
  • You are expected to make and keep all appointments associated with the study
  • You must be comfortable administering oral medications at home

Financial Incentives:

  • The oral immune therapy drugs (Palladia, losartan and propranolol) will be provided at no cost for the 1st 6 months of treatment.
  • All recheck appointment charges other than the exam fee during the initial 6 months of the study will be covered by the study, including blood work and blood pressure monitoring.
  • The study will also cover the cost of the recheck chest x-rays performed every 8 weeks
    for the first year of the study to assess your pet’s response to therapy.
  • After the initial 6 months of the study, you are responsible for all costs related to study
    participation other than chest x-rays.