Comparative Molecular Analysis for Acquired Toceranib Resistance in Dogs with Mast Cell Tumors (MCTs)

The University of Florida College of Veterinary Medicine is currently recruiting dogs diagnosed with non-resectable cutaneous Mast Cell Tumors (cMCTs) for a clinical research study. The purpose of this trial is to investigate novel biological characteristics associated with toceranib phosphate (Palladia®) resistance in canine cutaneous Mast Cell Tumors (cMCTs).

Enrollment Status: Currently Enrolling

• Inclusion Criteria: Any dog that has a confirmed diagnosis of cutaneous mast cell tumor (cMCTs) that is non-resectable and/or cMCTs that are non-eligible for other treatment modalities or whose owners declined other treatment modalities. Dogs may not enroll in this clinical study if they have received prior chemotherapy or radiation therapy as treatment for their mast cell tumor and may not receive concurrent antineoplastic therapies while enrolled in the study, exceptions may apply. The clinicians will further discuss eligibility criteria during the evaluation.
• Treatment: Before treatment, a tumor biopsy and a blood sample (approx. a tablespoon) will be collected under general anesthesia or sedation with appropriate pain control. Upon enrollment, every patient will undergo a complete history, physical examination, laboratory analysis, blood pressure measurement, and diagnostic imaging. Toceranib phosphate (Palladia®) will be administered orally, either every other day (EOD) or Monday-Wednesday-Friday (MWF), indefinitely if progressive disease is not observed (i.e., stable, partial, or complete response). Your dog will return for evaluation (physical examination, blood pressure measurement, clinical laboratory assessment of blood and urine, and tumor measurements) every 4 weeks until there is evidence of disease progression. Diagnostic imaging (e.g., radiographs and/or abdominal ultrasound) will be repeated to monitor your dog’s response to treatment at the discretion of the attending veterinary clinician. During the follow-up period, an additional tissue biopsy of the MCT will be necessary once resistance to Palladia is documented. Adverse Effects (AE) will also be evaluated at any unscheduled visit.
• Cost: The study will contribute a $300 incentive upon enrollment in this clinical trial and an additional $700 at the end of the study. Both incentives will be provided to cover veterinary services related to this trial provided to your dog. Other than this, you will be responsible for all costs. Specifically, you will be responsible for all costs associated with an initial screening to determine eligibility (physical examination, laboratory tests, X-rays, and/or abdominal ultrasound). Additionally, you will be responsible for all costs at scheduled study recheck visits, including the routine laboratory tests (physical examination, collection of blood and urine) and toceranib cost exceeding the incentives described above. If needed, you will also be responsible for additional examination costs (e.g., diagnostic imaging, biopsy, and histopathology). In the case that your pet cannot complete the study or has to be withdrawn from the study, you will not be eligible to receive the financial aid of $700 that you were supposed to receive at the time of the second biopsy.
• Contact: Contact the Oncology Staff at (352) 392-2235 to schedule an evaluation, or complete the Study Interest Form to see if your dog qualifies.

Background:

This study will investigate novel biological characteristics associated with toceranib phosphate (Palladia®) resistance in canine Mast Cell Tumors (MCTs). Understanding and identifying what causes Palladia resistance could help discover alternative or combination therapies to overcome it. Our main goal is to find better ways to manage dogs with MCT, a cancer whose prognosis remains poor due to the resistance to chemotherapy, emphasizing the urgent need for additional targets to develop more effective medical options based on precision medicine.