Evaluation of biomarkers to monitor benefits of toceranib in dogs with pulmonary metastatic osteosarcoma

Purpose

The goal of this multi-centered trial is to evaluate the effectiveness of toceranib for the treatment of dogs with osteosarcoma that has spread to the lung, and to evaluate markers in the blood that may help to determine which dogs will benefit most from toceranib treatment.

Background

Osteosarcoma (OSA) is a common cancer in dogs.  Current treatment options include surgery, radiation therapy and various types of chemotherapy; however, there are essentially no effective treatments for dogs with osteosarcoma that has spread (metastasized) to the lungs. Toceranib (PalladiaTM) is an oral drug that inhibits the function of a group of proteins important for cancer growth called receptor tyrosine kinases. Toceranib is approved by the FDA for the treatment of canine mast cell tumors, but there is preliminary evidence that some dogs with OSA may benefit from toceranib as well.  This trial will help to define the factors that influence response to toceranib therapy and thereby guide future studies to maximize benefit in dogs with OSA. 

Inclusion Criteria:

To qualify for enrollment in this study, dogs must have:
• Dogs with confirmed OSA that have undergone limb amputation and have lung metastasis that is visible on chest xrays.
• Dogs must undergo some diagnostic testing prior to starting the study to ensure that they are eligible, including bloodwork (complete blood count, chemistry profile), urinalysis and chest x-rays.
• Dogs must have good function of liver and kidneys, have acceptable blood cell counts, and be free of severe underlying disease.
• Concurrent use of other specific cancer drugs or homeopathic/alternative therapies is not allowed, but dogs that have been receiving nonsteroidal anti-inflammatory drugs are eligible to continue them at the discretion of the oncologist in charge.

Study Design

Initially your dog will undergo a series of diagnostic tests, which may include blood tests, urinalysis, blood pressure, and chest x-rays.  The results of these initial tests will determine if your dog is eligible to enter this clinical trial.  If deemed eligible, you will be sent home with oral toceranib to be administered to your dog 3 days per week. Rechecks will be required 2, 3, 4 and 8 weeks following the start of treatment. This study is not randomized and there is no placebo group – all dogs will receive toceranib. If your dog is doing well on the toceranib, then he/she will continue to receive free drug as long as this disease in the lungs is stable or better and the toceranib is being well tolerated; rechecks will be required every 8 weeks to continue to receive the free toceranib.

Client Compensation

• Toceranib will be provided at no cost.
• The first set of repeat chest x-rays, after 8 weeks of treatment, will be covered (paid for) by the study.

Client Cost

You will be responsible for the costs of the initial examination and tests to insure eligibility to participate, the recheck examinations, most of the blood tests, and ancillary medications.

Client Contact

Please contact the Clinical Trials Office at the Veterinary Medical Center for more information about this study.