Veterinary Medical Center

Purpose

The primary objective of this clinical trial is to evaluate the safety and tolerability of KUN C01 given to dogs with solid tumors (carcinomas, sarcomas, mast cell tumors, melanomas) and the secondary objective is to describe the antitumor response in tumor-bearing dogs.

Background

KUN C01 is a mixture of plant extracts that includes Rhus verniciflua, Ulmus hollandica, Polygonatum facatum, Lycium barbarum, Ganoderma ucidum, and Panax ginseng. Antiproliferative activities of KUN C01 were studied in the laboratory using mouse and human cancer cell lines demonstrating inhibition of the ability of these cells to grow. KUN C01 has been tested in ddY mice administered at 2.5 and 5 g/kg once per day without any sign of toxicity. It has also been administered safely to two dogs with cancer on a compassionate use basis without any obvious side effects. The antiproliferative effects of KUN C01 are believed to be due to the components luteolin and apigenin. Luteolin has shown to induce death of cells related to inhibition of Vascular Endothelial Growth Factor production and a reduction in Aurora B kinase activity blocking proliferation of cancer cells. Apigenin induces death by inhibiting STAT3 and decreases cell viability and telomerase activity in human leukemia cell lines. In addition, it has cancer preventative effects against selected carcinogens.

Inclusion criteria

To qualify for enrollment in this study, dogs must have:

• Histologic or cytologic diagnosis of cancer (biopsy or needle aspirate)
• There is at least 1 tumor (carcinomas, sarcomas, mast cell tumors, melanomas) which can be measured (minimum 1 cm in diameter)
• Generally feeling well (i.e. eating, drinking, ambulating on their own, etc.)
• No evidence of an active bacterial infection requiring antibiotics (other than topical medications) in the past 7 days
• No anti-cancer therapy within the past 21 days. This includes chemotherapy, radiation therapy, prednisone (or other forms of corticosteroids), and immunotherapy
• No tumors where abscess (infection) would result in major symptoms

Study Design

Twelve dogs with solid tumors amenable to repeated measurement will be enrolled into this clinical trial (divided in 4 groups). Each group will receive KUN C01 orally once per day starting at a dose of 4 mg/kg, with dose escalations in 2 mg/kg increments up to 10 mg/kg. Study assessments will be performed at Day 7 (routine blood work to monitor adverse effects, blood draws for pharmacokinetics, tumor response) and Day 30 (routine blood work, tumor response). If stable disease (SD), partial response (PR), or complete response (CR) is noted at Day 30, then owners will have the option of continuing to administer KUN C01 until the time at which progressive disease is noted or the dog develops side effects that prevent additiona treatment

Client Compensation

• All costs associate with the study are covered once the patient has been enrolled.

Contact Information

Dr. Francisco Clemente Vicario

Email: Francisco [dot] ClementeVicario [at] cvm [dot] osu [dot] edu

Phone: 614-688-5713 or 614-247-8706