Palladia® for Dogs with Mast Cell Tumors
Correlation of plasma levels of cytokeratin 18 with diarrhea in dogs with mast cell tumors treated with toceranib phosphate (Palladia®)
Purpose and Brief Study Description:
Palladia® is a receptor tyrosine kinase inhibitor (RTKI) that is being used with increasing frequency in veterinary oncology. Palladia® has been demonstrated to possess clinical benefit for dogs with a variety of tumor types, including mast cell disease. The most commonly encountered side effect(s) in dogs receiving Palladia® are gastrointestinal upsets, including diarrhea, colitis, vomiting, anorexia, and weight loss. These side effects are relatively more common with Palladia® than some of the conventional intravenous chemotherapy agents. Cytokeratin 18 (CK18) is released into the bloodstream following cell stress, such as that induced by the administration of chemotherapy. Consequently, plasma CK18 levels may represent a clinically useful biomarker to predict patient populations at higher risk for chemotherapy-associated gastrointestinal toxicity, and may help identify patients that would potentially benefit from prophylactic gastrointestinal tract protectants. This study has the potential to positively impact the quality of life in dogs undergoing anti-cancer therapy.
This is a collaborative study with the The Ohio State University Blue Buffalo Veterinary Clinical Trials Office.
Enrollment Criteria: --CLOSED--
- Dogs diagnosed by histopathology with cutaneous or subcutaneous mast cell tumors (MCT). Enrollment in this trial can only occur after surgical removal of the primary tumor, with no evidence of gross or visceral metastatic disease.
- Dogs must be at least 1 year of age.
- Dogs currently on steroids or NSAIDs may be eligible for enrollment after a 5 day wash out period
- Owner must be able to administer the drug orally at home according to their study schedule.
- Pregnant or lactating dogs
- Dogs who have had prior radiation or chemotherapy for treatment of mast cell tumors.
- Less than two weeks from a major surgical procedure.
- Concurrent use of complementary or alternative medicines.
What does enrollment into this trial involve?
Once enrolled into the study, dogs will receive Palladia® every other day, for a total of 28 days. The drug is administered orally, by the owner, at home. Weekly recheck visits will be required on study day 7, day 14, day 21, and day 28. At each recheck visit, blood will be collected to evaluate CK18 plasma levels. Additionally, a CBC will be performed on d14, and standard diagnostics on day 28, the final study day (CBC, chemistry profile, urinalysis, urine protein to creatinine ratio, and blood pressure).
For participation in this trial, Palladia® will be provided at no cost during the 4 week study period. After day 28, an additional 3 months of Palladia® is optional at no cost if further therapy is deemed appropriate by the attending Oncologist.
Initial screening chest radiographs and abdominal ultrasound will also be covered by study funds. Repeat staging (at day 28) and additional follow-up exams will be the financial responsibility of the owner.
For more information, please contact Misty Bear, Clinical Trials Coordinator:
Phone: (785)532-3046, email:ClinicalTrials@vet.k-state.edu