Clinical Trial Updates



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Clinical Trial Updates I N T H I S I S S U E : Upcoming Studies New Recruiting Trials Ongoing Trials Completed Trials Clinical Research Trial High- Lights Hospital Name Change I S S U E 4 Upcoming Studies J U N E 2 0 1 0 Evaluation of Orally Administered mtor inhibitor Rapamycin in Tumor Bearing Dogs This clinical trail sponsored by the National Cancer Institute (NCI) is an open label, prospective preclinical trial of orally administered rapamycin in tumor bearing dogs. : Histologically confirmed malignancy Measurable disease Both newly diagnosed and those with recurrent disease >15 kg in size No concurrent chemotherapy or radiation therapy 72 hour NSAID washout prior to study initiation No history of IBD or chronic gastroenteritis; no significant co-morbid illness Clinician: Dr. Bill Kisseberth New Recruiting Trials Computed tomography for evaluation of canine intestinal obstruction Vomiting is a common problem in dogs that is often caused by intestinal obstruction. Abdominal radiographs (x-rays) are used to determine if intestine is obstructed (blocked), but radiographs may appear normal even if the intestines are obstructed. In people, intestinal obstruction is more accurately diagnosed using computed tomography or CT scans. Our study will determine if CT is more accurate for detecting intestinal obstruction vs. abdominal radiographs. Dogs that are having abdominal surgery for a nonintestinal problem Dogs with suspected intestinal obstruction Clinician: Dr. Tod Drost

I S S U E 4 P A G E 2 New Recruiting Clinical Trials Pilot Test of a method to relax the ureter of animals to facilitate passage of ureteral stones Ureteral stones are difficult to remove and can cause significant pain and illness. The purpose of this study is to test in 2 dogs the effect of local application of a drug to relax the ureter and permit passage of the stone If successful, this study will likely leas to a larger controlled trials and could eventually become a safe, cost effective alternative for treatment of ureteral stones in dogs, cats, and humans. Confirmed ureteral stones Must have good liver and kidney function Free of severe underlying disease Clinician: Dr. Tony Buffington Copy Number Variation The goal of this study is to better understand the genetic basis of disease in dogs by defining common variation in dog breeds. See Study Highlights for details N-Benzyladriamycin-14-valerate (AD 198) for the treatment of canine lymphoma The purpose of this study is to evaluate the safety and effectiveness of the novel doxorubicin analog AD 198 in canine's with relapsed/drug resistant lymphoma. Histologically confirmed LSA; newly diagnosed or relapsed Age > 1 year Have an estimated life expectancy of at least 3 weeks Have adequate organ function No chemotherapy or radiation within 2 weeks of enrollment No Corticosteroids or NSAIDs within 48 hours of enrollment Clinician: Dr. Cheryl London A Randomized Clinical Trial of Cemented versus Cementless Total Knee Replacement (TKR) in Dogs In this study, we would like to perform a side-by-side comparison of two types of canine total knee replacement (TKR) implant, one of which is a standard implant that is secured to bone with bone cement, while the other is intended for use without bone cement ( cementless fixation ). The overall goal of this study is to document clinical function and the long-term performance of the implant and to develop a TKR implant that lasts the duration of the animal s life. Clinician: Dr. Matthew Allen

I S S U E 4 P A G E 3 Continued Treatment of Canine Keratoconjunctivitis Sicca with an Aqueous Formulation of Cyclosporine The causes of KCS are numerous and include inherited, age-related, breed-associated and drug-induced. In most affected dogs the disease is incurable requiring lifelong topical medications and on occasion, surgery. The goal of this study is to evaluate the safety and effectiveness of a water-soluble form of cyclosporine which would be more user friendly for the owner, easier to administer and hopefully more bio-available improving owner compliance and patient response. Confirmed diagnosis of KCS Not currently being treated with a cyclosporine-type drug Clinician: Dr. David Wilkie Preclinical comparison of three indenoisoquinolone candidates in tumor-bearing dogs: A pilot study of topotecan in dogs with lymphoma This clinical trial assesses the safety and effectiveness of Topotecan and novel Topoisomerase I inhibitors when given to dogs with lymphoma. Histologically confirmed LSA Minimal node size of 2 cm Both newly diagnoses and those with recurrent/relapse disease Favorable performance status: Grade 0 or 1 No concurrent chemotherapy or radiation therapy Corticosteroid washout of 7 days prior to study drug No significant morbid illness Clinician: Dr. Bill Kisseberth The Histological Effect of Semi-Conductor Diode Laser Trans-Scleral Cyclophotocoagulation on Buphthalmic Equine Globes The purpose of this study is to determine if the currently used location and energy setting for semiconductor diode laser trans-scleral cyclophotocogaulation are appropriate for buphthalmic equine globes. : Horse having a blind glaucomatous eye removed Clinician: Dr. Anne Metzler

P A G E 4 Got Straining? Ongoing Clinical Trials Equine Cell-Mediated Bone Morphogenetic Protein Gene Therapy for Bone Healing in Horses Internal Medicine A Study to Evaluate the Efficacy and Safety of an Alternative Antibiotic Treatment Regimen for Lower Urinary Tract Infection in Dogs Oncology Liposomal Clodronate for the Treatment of Malignant Histiocytosis $300 to your clinic for refereed UTI patients Maintenance Therapy with Toceranib (Palladia) Following Doxorubicin-Based Chemotherapy for Canine Splenic Hemangiosarcoma Safety Evaluation of Combination Vinblastine and Toceranib (PalladiaÒ): A Phase Dose Finding Study Completed Studies Dietary Nucleotides in Dogs Undergoing Anticancer Chemotherapy for LSA or OSA Primary Secretory Otitis Media in Cavalier King Charles Spaniels Palladia Plus Radiation Therapy for Canine Mast Cell Tumor Radiology Computed Tomography (CT) Imaging in Canine Osteosarcoma of the Appendicular Skeleton Current Clinical Research Critical Care Characterization of Coagulation Changes in Acutely Traumatized Dogs using Thromboelastography Abdominal Effusion Associated with Decompressive Cystocentesis in Male Cats with Urethral Obstruction Incidence of Urinary Tract Infection Associated with Urinary Catheterization in Feline Urethral Obstruction Food Animal The Effects of Mycoplasma Haemolamae Genetics to Virulence, Detection, and Vertical Transmission Equine Bacterial Translocation in Horses with Strangulating Small Intestinal Lesions Hydrocortisone Replacement Therapy in Septic Horses Shelter Medicine Effect of Cage Enrichment and Predictability on Health Outcomes in Shelter Cats C L I N I C A L T R I A L U P D A T ES

Trial Highlights Copy Number Variation The overall goal of this study is to better understand the genetic basis of disease in dogs by defining common variation in dog breeds. We are specifically interested in a type of genetic change, copy number variation (CNV), which has been found to be both disease causing and part of normal variation in humans. In order to identify disease causing CNV, we are collecting blood and saliva samples from healthy dogs and dogs with a number of diseases. Our main purpose in collecting these samples will be to isolate DNA in order to catalog these changes for a high detail CNV map. This map can then be used to determine CNV disease associations in specific dog breeds by comparing healthy and diseased dogs. We are looking for dogs that are AKC registered and are of a breed listed below Dogs can be healthy or have the disease listed. Lymphoma patients need to be newly diagnosed or have not received chemotherapy. Breeds Disease Breeds Disease Beagle Golden Retriever Lymphoma Border Collie Great Dane Wobbler Syndrome Boxer Lymphoma Labrador Retriever Atopic Ureter Cocker spaniel Lymphoma Rottweiler Lymphoma Bulldog Glioma, kidney stones, mitral valve defects Shar pei Lymphoma Doberman Pinscher Wobbler Shih-tzu Glioma Syndrome German Shepherd Lymphoma Yorkshire Terrier Atopic ureter or UTI German Shorthaired P. Epilepsy Study Design: This is a one time collection of 20 mls of blood, along with a photograph of the dog. The clients will need to have their AKC paper and sign a consent form; they are not responsible for any costs. Clients can contact the CTO to schedule an appointment. C L I N I C A L T R I A L U P D A T ES

Veterinary Teaching Hospital renamed: Veterinary Medical Center The Veterinary Teaching Hospital has been re-named The Ohio State University Veterinary Medical Center, with approval from the University Board of Trustees. The Veterinary Medical Center consists of the Hospital for Companion Animals, the Hospital for Farm Animals, and the Galbreath Equine Center, all under the umbrella of the College of Veterinary Medicine. This change offers the opportunity to promote the breadth and depth of services offered. While our mission will always be centered on educating veterinarians - from our own DVM students to the interns and residents who count on our expertise to guide them to specialty board certification - the new name provides a broader understanding of our diagnostic and specialty treatment capabilities. We realize there will be a gradual period of transition as we roll out the new name and incorporate it into our daily use and language. You will soon see our new logo on publications and we will change wording on our website, signage, and on internal documents. Clinical Trials Office 0117 Veterinary Medical Center 601 Vernon L. Tharp St. Columbus, OH 43210 Phone (614) 688-5713 Phone (614) 247-8706 Fax (614)292-6464 http://vet.osu.edu/clinicaltrials.htm