Comparative Molecular Analysis for Acquired Toceranib Resistance in Dogs with MCT& Liquid Biopsy for Early Relapse Detection and Improved Treatment of Mast Cell Tumors (MCTs)

The University of Florida College of Veterinary Medicine is currently recruiting dogs diagnosed with 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

• Study Criteria: Any dog that has a confirmed diagnosis of cutaneous mast cell tumor (cMCTs). 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.

• Procedures and Treatment: Before Palladia treatment, a tumor biopsy and a blood sample (approx. a tablespoon) will be collected under general anesthesia or sedation with appropriate pain control. For surgical candidates, this step may be completed on the same day as surgery. For enrollment, every patient must complete the baseline evaluation. The components of the baseline evaluation depend on the clinical trial your dog is eligible for. All of the baseline evaluations must be completed within one month of starting Palladia therapy. 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/or tumor size 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. Once resistance to Palladia is documented, the second sampling of the MCT (either fine needle aspiration or tissue biopsy) will be necessary. Adverse Effects (side effects) will also be evaluated at all visits. Owners will be asked to fill out Quality of Life questionnaires prior to the visits. Owners must make and keep all appointments according to the study protocol.

• Cost: The study will contribute a $300 towards enrollment in this clinical trial, and some patients will be eligible for an additional $700 in financial coverage towards care at the end of the study. These incentives are provided to cover veterinary services related to this trial provided to your dog.
• You will be responsible for all other costs associated with the plan of care, e.g., an initial screening to determine eligibility (physical examination, laboratory tests, X-rays, and/or abdominal ultrasound with tissue sampling); all costs at scheduled study recheck visits, including the routine laboratory tests (physical examination, collection of blood and urine) and Palladia costs. Owners are also responsible for any additional costs (e.g., diagnostic imaging, biopsy, and histopathology) further associated with your dog’s care.
• Please note the following: The study investigator may take your pet out of this clinical trial without your permission at any time due to non-compliance, and this will forgo the financial incentive. Lastly, this clinical trial may end early at the investigator’s discretion. If your dog’s participation in the research ends early, you may be asked to visit the investigator for a final visit before the second biopsy. If so, you will also not be eligible to receive the financial aid of $700 that you were supposed to receive at the time of the second sampling.

• 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 the mechanisms underlying resistance to toceranib phosphate (Palladia®) in dogs with Mast Cell Tumors (MCTs). Liquid biopsies detect tumor cells, DNA fragments, or other biomarkers that may indicate cancer in bodily fluids. This will be used to detect features associated with acquired Palladia resistance. One of the key parts of this study is to validate liquid biopsy using deep-targeted sequencing of circulating cell-free and circulating tumor DNA to monitor for minimal residual disease.
Results are expected to allow for the optimization of treatment strategies and the identification of novel therapeutic target(s). These may have a positive impact on patients’ outcomes or quality of life and may also lead to alternative or combination therapies to overcome Palladia resistance