Clinical Trials Newsletter Nov/Dec 2012

The Clinical TrialsOffice/Tissue Bank

Clinical Trials
The Clinical Trials Office coordinates studies ranging from heart problems to eye diseases, cancer to neurological problems, all in pursuit of life-saving discoveries.

Clinical trials represent the cutting edge of medicine: research expertise meets new treatments and improved outcomes, including an improved understanding of the diseases that affect our animals and best friends.

http://vet.osu.edu/vmc/clinical-trials

Biospecimen Repository
The Tissue Bank (Biospecimen Repository) collects samples of tumors and normal tissue from dogs and cats, and stores these tissues under controlled conditions for future use by multiple investigators. The Tissue Bank at The Ohio State University was selected by the Canine Comparative Oncology Genomics Consortium (CCOGC) as one of three veterinary institutions nationwide to participate in populating the Pfizer-CCOGC multi-institutional Tissue Bank. This National Cancer Institute-sponsored endeavor emphasizes the importance of comparative oncology research. The Tissue Bank at The Ohio State University follows the guidelines established by the CCOGC for several specific types of tumors and similar established protocols for other tumors. Tissues are collected and archived only after receiving consent from the owners. This sample bank will serve as a tremendous resource with the ultimate goal of developing new prevention and treatment strategies for dogs with a variety of illnesses.

http://vet.osu.edu/biosciences/tissue-bank

Welcome our new staff member-Annie Adrian!

The CTO would like to welcome Anna (Annie) Adrian to our office as the new Administrative Program Assistant. Annie is from London Ohio. She has some animal background with horses being her main focus. Horses are both her hobby and life. She loves doing everything with them. She is married and has a daughter. They reside out in the country close to Mt. Sterling. She says “I think I am a well-rounded person with some knowledge in several areas pertaining to the job.” We are happy to have Annie join our team!

COTC007b: Preclinical Comparison of Three Indenoisoquinolines Candidates in Tumor Bearing Dogs

Lymphoma is one of the most common cancers in dogs, accounting for 7% to 24 % of all canine cancers. Although most dogs with lymphoma respond intially to current chemotherapy drugs, most eventually develop drug resistance. This clinical trial sponsored by the National Cancer Institute (NCI) assesses the safety and effectiveness of three newly developed chemotherapy agents (indenoisoquinolines) when given to dogs with lymphoma. Although this class of compounds has shown efficacy in a variety of cancers, interest in developing new topoisomerase I inhibitors, indenoisoquinolines, are currently being evaluated in human patients as agents with improved drug stability and measurable blood levels. This study is the first time the indenoisoquinolines are being assessed in dogs with cancer. This trial is divided into 2 phases. The first phase is a dose finding phase to determine safety followed by a validation phase for biological assay development (tumor marker evaluation pre and post treatment). Anti-cancer activity against canine lymphoma will be assessed in both phases.

Patient Eligibility Criteria:
Dogs with confirmed diagnosis of lymphoma with at least one lymph node larger than 3 cm diameter are eligible to participate. Dogs may be newly diagnosed or have previously received treatment. A two week washout period from previous chemotherapy or radiation therapy is required and dogs must not have received corticosteroids or L-asparaginase seven days prior to entry into the study. Dogs must be feeling well and otherwise be in good overall health with adequate organ function, as determined by recent blood work, to participate in this study. Study period is 29 days with visits on days 1,3,5,8,15,22 and 29.

Financial Incentives

Once enrolled in this study, all costs associated with the study will be covered. Adverse events and unanticipated hospitalizations are also covered. Once the study has been completed, a $1000 credit will be applied to your dog’s account at the OSU Veterinary Medical Center which can be used for further treatment.

For more information please contact the Clincal Trials Office at 614-688-5713 or 614-247-8706
clinicaltrials [at] cvm [dot] osu [dot] edu

http://vet.osu.edu/vmc/cotc007b-preclinical-comparison-three-indenoisoquinolines-candidates-tumor-bearing-dogs

Brainstem Auditory-Evoked Response Testing In Normal Hearing Cavalier King Charles Spaniel Dogs

The American Cavalier King Charles Spaniel Club Charitable Trust and The Ohio State University Paladin Fund has funded and made possible research to be done by Dr. Lynette Cole, at The Ohio State University, College of Veterinary Medicine, Veterinary Medical Center.

OVERVIEW OF THE STUDY:
Hearing disorders are a common condition recognized in many breeds of dogs. In the dog breed Cavalier King Charles Spaniel (CKCS), hearing disorders may be due to conductive hearing loss, which may occur with primary secretory otitis media (PSOM), or due to sensorineural hearing loss, which may occur when there is damage or an abnormality of the sensory cells in the cochlea or the auditory nerve. Evaluation of a dog’s hearing ability is done using the brainstem auditory evoked response (BAER) test. However, in order to identify an abnormality on the BAER test, the results from an individual dog must be compared to normal BAER values.

PURPOSE OF THE STUDY:
The purpose of this study is to obtain BAER data from CKCS dogs between the ages of 1 to 2 years old with no history of hearing loss. This is a 2-day study. Procedures performed include hearing testing (BAER test), a Computed Tomography (CT) scan and Magnetic Resonance Imaging (MRI); study pays for all testing.
Enrollment of dogs in the study has begun. If you are interested in possibly enrolling your CKCS dog in the study, please contact Dr. Cole at the telephone number or email address listed below. A pedigree is required for entry into the study, but will be kept confidential, as will all test results. Details of the study will be given individually on the phone or via email.

Contact:
Dr. Lynette Cole DVM, MS, Dipl. ACVD
Dermatology and Otology Service, Veterinary Medical Center
The Ohio State University, 601 Vernon L. Tharp Street,
Columbus, OH 43210
Tel: (614) 292-3551
Email: cole [dot] 143 [at] osu [dot] edu

http://vet.osu.edu/vmc/brainstem-auditory-evoked-response-testing-normal-hearing-cavalier-king-charles-spaniel-dogs

An Exploratory Study of the Oral Selective Inhibitor of Nuclear Export (SINE) KPT-335 in Dogs with Lymphoma

The Ohio State University Clinical Trials Office at the Veterinary Medical Center is currently recruiting dogs diagnosed with Lymphoma (LSA) to participate in a new study titled, An
Exploratory Study of the Oral Selective Inhibitor of Nuclear Export (SINE) KPT-335 in Dogs with Lymphoma. This is a multi-center study effort led by Dr. Cheryl London to evaluate the safety and antitumor activity of KPT-335 in dogs with lymphoma, either newly diagnosed or in first relapse after completion of a single chemotherapy protocol (multi-agent or single agent).

Minimum inclusion criteria for all of these studies are:

Histologic or cytologic diagnosis of Lymphoma
Dogs must be newly diagnosed or in first relapse after completion of a single chemotherapy protocol. Both B and T Cell accepted
Dogs must have progressive disease(measurable lymph nodes)
Life expectancy >28 days
Performance status of 0 or 1
No anti-cancer therapy within the past 2 weeks prior to enrollment
No severe, complicating concurrent disease conditions

To find out more information or if you have any questions please visit http://vet.osu.edu/vmc/exploratory-study-oral-selective-inhibitor-nuclear-export-sine-kpt-335-dogs-lymphoma or contact the Clinical Trials Office at the Veterinary Medical Center by email at (clinicaltrials [at] cvm [dot] osu [dot] edu) or by phone at 614-292-4559 or 614-247-8706.

Improving outcome in dogs with glomerular disease via pharmacodynamic-based dosing of enalapril

One in five pet dogs will develop kidney disease at some point. Proteinuric glomerular diseases may be the underlying cause of chronic renal failure in at least 50% of canine patients with chronic renal failure. Glomerular disease is a type of kidney disease in which the parts of the kidney (glomerulus) that help filter waste and fluids from the blood and keep protein from being removed is damaged. Proteinuria (protein in the urine) is the first indicator that there is a kidney problem.

This study will evaluate the effectiveness of giving a higher dosage of Enalapril to dogs suffering with kidney disease. Enalapril is an angiotensin converting enzyme inhibitor (ACE inhibitor or ACEi). What this means is that enalapril stops the angiotensin converting enzyme from producing a compound called angiotensin-ll, which is a potent vasoconstrictor. Vasoconstrictors cause the narrowing of blood vessels which ultimately leads to decreased blood flow. Enalapril acts as a vasodilator because it blocks the production of angiotensin-ll. Essentially, by acting as a vasodilator, enalapril acts to increase the diameter of the blood vessels instead of narrowing them. This increase in the diameter of the blood vessels results in increase blood flow. Enalapril can aid in increased blood flow to the kidneys, which has been shown to be beneficial to dogs that are experiencing kidney disease. It is believed that enalapril and other ACE inhibitors probably decrease the amount of protein that is allowed to escape through the kidneys and into the urine. The current recommended enalapril dose was established using 75% suppression of ACE activity as the desired pharmacodynamic end-point; however, recent studies in people suggest that higher ACEi doses required for maximal reduction in urine protein excretion may dramatically improve patient survival. Data collected from this study will not only benefit dogs but humans as well.

Inclusion Criteria/Client Compensation

Dogs must have primary glomerular disease. They cannot be diagnosed with nephrotic syndrome, a concurrent disease that will alter kidney function or any condition that would result in less than 12 months of survival. Your dog’s urine protein:creatnine ratio must be great than or equal to 3.0. All other labwork will need to be within normal range. Owners must commit to returning to OSU for regular recheck appointments. The duration of the study is roughly 36 weeks with a variation of appointments depending on which group your dog is placed into. The study sponsor will cover all cost associated with the study once your pet is enrolled, however the owner is responsible for initial screening visit, purchase of enalapril, and any other medications needed for standard treatment of their dog’s kidney disease. If any unforseen events occur these cost are covered up to $1000.

If you have questions, concerns or would like to schedule an appointment please contact:

Dr. Barrak Pressler
(614) 292-5337
barrak [dot] pressler [at] cvm [dot] osu [dot] edu
or
The Clinical Trials Office
(Nicole Stingle or Tamra Mathie, clinicaltrials [at] cvm [dot] osu [dot] edu)

http://vet.osu.edu/vmc/improving-outcome-dogs-glomerular-disease-pharmacodynamic-based-dosing-enalapril

Utility and Repeatability of Quantitative Outcome Measures to Assess Recovery after Canine Spinal Cord Injury (SCI)

The purpose of this study is to adapt several tests of sensory and motor function commonly used in rodent SCI models for dogs and to assess the utility and reliability of these tests in measuring recovery from SCI in dogs.

This study would like to enroll both normal and affected dogs.To qualify for enrollment in this study, dogs must:
Have a diagnosis or presumed diagnosis of intervertebral disc herniation.
OR be neurologically and orthopedically normal (control group)
< 15 kg and of chondrodystrophic breeds

For more information on enrollment and other criteria please visit the following link: http://vet.osu.edu/vmc/utility-and-repeatability-quantitative-outcome-measures-assess-recovery-after-canine-spinal-cord

Upcoming Studies

Oncology
Several new studies are being developed and will begin enrollment in the new year.

Dermatology
Efficacy of a Vaccine against a key cytokine involved in canine atopic dermatitis as an Aid in Reduction or Control of Clinical Signs Associated With Canine Atopic Dermatitis
Study covers the costs associated with the study at each visit
Advantage Multi for Dogs will be supplied during the study
Please contact Dr. Hillier about potential patients at hillier [dot] 4 [at] osu [dot] edu or 614-292-3551

http://vet.osu.edu/vmc/title-efficacy-vaccine-against-key-cytokine-involved-canine-atopic-dermatitis-aid-reduction-or-c

IMED
Association between Helicobacter pylori infection and uremic gastritis in dogs
The purpose of this study is to investigate whether stomach changes in dogs with CKD are similar to those noted in people with CKD and Helicobacter infections, and determine if anti-Helicobacter pylori treatment improves clinical signs and prognosis in dogs with CKD.

Spotlight Patient

Misty

Winston is an 8-year-old mixed breed dog who presented to the OSU-VMC Medical Oncology Service for evaluation of a mast cell tumor that was present on the left side of his chest. The tumor had been removed twice and had grown back both times, and now was quite large. Winston was entered into the STA-1474 clinical trial evaluating a new heat shock protein 90 (HSP90) inhibitor in dogs with mast cell tumors. He did very well throughout the 5 week study, and his tumor was almost completely gone by the end of his treatment. Winston has just finished a course of radiation therapy to hopefully get rid of any remaining tumor cells and is now enjoying his time hanging out on the front porch. Thanks to Winston and his family for helping us with this study!

To see ALL of our current recruiting trials please visit our website at http://vet.osu.edu/vmc/current-recruiting-clinical-trials

Ongoing Studies

Equine

Cell-Mediated Bone Morphogenetic Protein Gene Therapy for Bone Healing in Horseshttp://vet.osu.edu/vmc/evaluation-kun-c01-dogs-spontaneous-solid-tumors

Orthopedic Surgery

Radiology

Computed Tomography for Evaluation of Canine Intestinal Obstruction

Ophthalmology

Cardiology

Acute effect of Ivabradine, a novel I-f current inhibitor, on dynamic obstruction of the left ventricular outflow tract in cats with preclinical hypertrophic cardiomyopathy

Oncology/Radiation Oncology

Neurology

The role of hsp70, IL-1ß and TNF- α responses in recovery after canine spinal cord injury; a pilot investigation

Internal Medicine

Improving outcome in dogs with glomerular disease via pharmacodynamic-based dosing of enalapril

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