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The goal of this study is to determine the anti-tumor activity of Palladia against canine hemangiosarcoma.
Hemangiosarcoma (HSA) is a common cancer in dogs that arises from vascular endothelium (blood vessels). HSA have a very aggressive biologic behavior, and in most cases, rapid and widespread metastasis. Death due to disease is seen in 90% of patients within 1 year when treated with doxorubicin based chemotherapy. It has been demonstrated that the majority of canine HSA express the receptor tyrosine kinases KIT and VEGFR2, both of which are targets of the veterinary tyrosine kinase inhibitor (TKI) toceranib (SU11654, Palladia®, Zoetis (Formally Pfizer)). Furthermore, it has been demonstrated that both VEGFR2 and KIT signaling can be blocked in HSA tumor cells, and that blocking these pathways in mouse models of canine HSA can slow tumor growth. This study is an open-label, single-arm, phase-II, multicenter clinical trial, and is first evaluation of KIT/VEGFR2 inhibitors as therapy for dogs with HSA.
To qualify for enrollment in this study, dogs must:
Dogs with histologically confirmed, stage I or II, splenic HSA undergoing spleen removal <21 days prior to treatment initiation will all be treated with 5 cycles of single-agent doxorubicin. Two weeks following the 5th treatment, all dogs will be re-staged with abdominal ultrasound and 3-view chest radiographs. Those dogs remaining free of metastatic disease will receive Palladia every other day. They will be rechecked at week 1, week 2, and week 4 following treatment initiation and then every 4 weeks thereafter. A complete blood count will be performed at every visit. A serum biochemistry profile and urinalysis will be performed every 8 weeks thereafter. Complete re-staging, consisting of chest radiographs and abdominal ultrasound, will be performed every 8 weeks following Palladia initiation for a total of 32 weeks of follow-up following initiation of Palladia therapy.
Dr. Cheryl London
clinicaltrials [at] cvm [dot] osu [dot] edu