CSU Animal Cancer Center Clinical Trial

Patient Disease:
Mast cell tumor.

Study Name:
Palladia plus radiation therapy.

Purpose of the study:
Mast cell tumor is a common skin tumor of dogs. Current treatment options available for mast cell tumor include various combinations of surgery, chemotherapy drugs such as vinblastine or lomustine, radiation therapy, and the new oral mast cell tumor drug Palladia^® (toceranib).

Palladia is an oral drug which works by inhibiting the function of a protein important for mast cell survival called KIT. Large studies have demonstrated that Palladia can be effective for some canine mast cell tumors. However, most mast cell tumors treated with Palladia do not go away completely, and improvement with Palladia is not permanent. Through this clinical trial, we are seeking to determine whether the addition of radiation therapy to Palladia will result in a higher likelihood of tumor shrinkage, and/or a longer duration of improvement.

Patient Entry Criteria:
There are certain criteria to determine if your pet will qualify for this study. Dogs with confirmed mast cell tumor, with or without lymph node involvement, are eligible for this study. Dogs must undergo some diagnostic testing prior to starting the study to ensure that they are eligible. They must have good function of liver and kidneys, have acceptable blood cell counts, and are free of severe underlying disease. Prior surgery or medical treatment for mast cell tumor is acceptable, with a 2-week washout from prior chemotherapy or surgery.

Owner Responsibilities:
The owner is responsible for scheduling appointments with the oncology clinical trials coordinator and keeping those appointments as required by study protocol. These appointments will cover both the treatment and follow-up periods. You are responsible for the cost of diagnosing and staging your dog’s mast cell tumor prior to entering the study (approximately $600.00-800.00). You are expected to make and keep all appointments according to the study protocol. You must be committed to completing the entire study protocol and follow-up examinations.

Owners are responsible for administering any medication prescribed by the primary clinician and advising of any changes or adverse effects.

In the event that the patient dies during the study, owners are requested to contact the study director or clinical trials staff and commit to a necropsy.

Financial Incentives:
Clients participating in this study will be given special financial considerations. The study will pay for Palladia, radiation therapy, and blood monitoring for 16 weeks following the start of treatment. Following this period of time, blood tests to insure that Palladia is being tolerated (approximately $85 per visit) will become the responsibility of the owner. The owner will be responsible for the initial tests to insure eligibility to participate, the cost of recheck examinations, and the cost of ancillary medications (Benadryl, omeprazole, prednisone).

Please contact our Consultation Coordinator at (970) 297-4195 if you are interested in learning more about clinical trials.