Clinical Trial Updates March 2012 E-Newsletter

Our mission

The Clinical Trials Office (CTO) provides assistance in the design, execution, and evaluation of veterinary clinical trials using client-owned animals, with the overriding goal of advancing the diagnosis and treatment of disease in veterinary patients while enhancing the health of humans.

New Recruiting Studies

Cats needed for Cardiology Studies

The Ohio State University Clinical Trials Office is currently recruiting new cats to participate in one of two ongoing Hypertrophic Cardiomyopathy. Hypertrophic cardiomyopathy (HCM) is a disease of the myocardium in which a portion of the myocardium is hypertrophied (thickened) without any obvious cause. HCM s the most common heart disease in cats predisposing cats to the development of congestive heart failure (CHF), thromboembolic disease, and sudden death. The first study titled Study of the Effects of Pimobendan on Hypertrophic Cardiomyopathy in Cats would like to investigate the short- and long-term effects of oral pimobendan, an inodilator drug, in cats with hypertrophic cardiomyopathy (HCM) and congestive heart failure (CHF), with and without left ventricular outflow tract obstruction (LVOTO). http://vet.osu.edu/vmc/study-effects-pimobendan-hypertrophic-cardiomyopathy-cats

The other study title the 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 would like to determine if Ivabradine does reduce dynamic obstruction of the left ventricular outflow tract in cats with Hypertrophic cardiomyopathy (HCM). http://vet.osu.edu/research/acute-effect-ivabradine-novel-i-f-current-inhibitor-dynamic-obstruction-left-ventricular-ou

Clinical Trial Highlights

Has your dog been suffering from Dry Eyes?

The Ohio State University Clinical Trials Office at the Veterinary Medical Center is currently recruiting new dogs diagnosed with Keratoconjunctivitis sicca (Dry Eye) to participate in an ophthalmology study. The study, being led by Dr. David Wilkie from the Ohio State University, Clinical Assessment of ZP-1 in Reducing Clinical Symptoms Associated with KCS in Dogs would like to evaluate a water-soluble form of cyclosporin as compared to the same concentration of cyclosporine compounded normally delivered in a oil-based form. Keratoconjunctivitis sicca (Dry Eye) is a common ophthalmic disease that affects humans and dogs. The prevalence of dry eye in humans is reported to be 14%. In animals, the American Cocker Spaniel is the most commonly affected breed with a prevalence of 20%. The overall prevalence of dry eye in the canine has been reported to be 4%. The causes of canine dry eye 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. Dry eye results in cumulative and often irreversible damage to the cornea leading to corneal scar, vascularization, pigmentation and vision loss. In addition, the disease can be chronically painful.

To qualify for enrollment in this study, dogs must: Have a confirmed diagnosis of KCS (STT <15mm/mm) and have never been treated for the condition. Client compensation will consist of the sponsor covering all study associated costs as well as provide clients with a $300 preloaded credit card at the completion of the study.For more information: http://vet.osu.edu/vmc/clinical-assessment-zp-1-reducing-clinical-symptoms-associated-kcs-dogs-0

Spinal Cord Injury Study Seeking Canine Recruits

Recently, studies have shown that secondary immune-mediated damage to nervous tissue is an important cause of failure to recover after spinal cord injury (SCI). The presence of pro-inflammatory molecules such as hsp70, IL-1β and TFN-α in spinal fluid may represent important prognostic indicators of recovery as well as potential therapeutic targets to improve functional outcome in canine SCI patients. This study is designed to document whether hsp70, IL-1β and TFN-α responses occur in the spinal fluid of a small number of dogs with SCI cause by intervertebral disc extrusion.

Study design: Dogs will have a blood sample drawn while under general anesthesia for diagnostic imaging and surgery for their intervertebral disc disease. Spinal fluid will also be collected at this time. Dogs will be assigned an injury severity score on initial exam, and again at 3, 10, 30 and 90 days after surgery.

Who is eligible?

-Dogs weighing < 15 kg (33lb) are eligible to participate,

-Dogs should have acute intervertebral disc disease severe enough to require surgery.

-Dogs must have been "down" for < 48 hours prior to referral.

-Dogs must NOT have received steroids within the 7 days prior to study enrollment.

What are the benefits clients?

- Owners will receive a $100 credit toward their bill for participating in the study.

-All study-related rechecks (10, 30 and 90 days post-op) will be covered by the study.

-A small allotment of funds is available to provide additional support to qualifying cases owned by clients with significant financial constraints. These will be assessed on a case-by-case basis.

Please contact Dr. Sarah Moore at 614-292-3551 or moore [dot] 2204 [at] osu [dot] edu with study-related questions.

Ongoing Studies

Equine

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

Internal Medicine

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

Patient of the Month-Hanz

Hanz is a 9.5 yr german shepherd dog that was diagnosed with OSA of the left distal radius. He underwent limb amputation on 9/29/11 and enrolled into the Palladia/Piroxicam/Cyclophosamide Treatment for Dogs with OSA clinical trial on 10/10/11. He received 4 doses of Carboplatin every 3 weeks, and on 1/13/12 was found to be free of metatisis. He was then randomized to be in the Palladia group meaning he would receive Palladia along with his Piroxicam/Cyclophosamide. He has been on this treatment for a month and doing very well.

Hanz was a active dog and always enjoyed daily walks with his owners before his diagnosis and amputation. Like most owners, they were worried about how Hanz would handle only having 3 legs and how chemotherapy would affect his quality of life. As you can see from the picture, he has maintained a great quality of life during chemotherapy and
has no issues adapting to life with 3-legs.

Upcoming Studies

COTC018-Starts March 7, 2012

The Ohio State University Clinical Trials Office at the Veterinary Medical Center is currently recruiting dogs diagnosed with malignant mammary carcinoma, melanoma, oral squamous cell carcinoma, or soft tissue sarcoma to participate in a clinical trial to explore and define the biological changes in these tumors and normal tissues following exposure to the chemotherapeutic drug iniparib. This is a Comparative Oncology Trials Consortium (COTC) clinical trial coordinated through the Comparative Oncology Program at the National Cancer Institute (NCI). COTC018: Evaluation of iniparib in tumor bearing dogs to define its pharmacokinetic profile and biological activity is designed to answer questions about iniparib and its metabolite pharmacokinetics and biological activity in tumors, normal tissues and surrogates. Mining for novel biomarkers or signatures of iniparib mechanism is the study’s main objective. Exposure-pharmacodynamic relationships will also be defined. Data generated through this effort will inform the use and development of iniparib for clinical studies in human cancer patients.

Inclusion Criteria:

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

histologically or cytologically confirmed melanoma, head and neck carcinoma or soft tissue sarcoma (amenable to serial biopsy; histology may be confirmed by pre-treatment biopsy)
histologically confirmed malignant mammary carcinoma (malignancy must be confirmed to establish eligibility)
- Enriched enrollment of at least 6 dogs with mammary carcinoma required (3-5 for control group)
naïve or recurrent (previous surgery) disease
favorable performance status
- Grade 0 or 1 (modified ECOG criteria)
informed owner consent for trial (approved by IACUC)
dogs must undergo necropsy if death occurs on study

Study Design:

Enrollment Evaluation:

The following are required for enrollment and can be performed at the OSU-VMC < 3 days before drug administration:

thoracic radiographs
abdominal ultrasound (if clinically indicated)
measurement of tumor burden (target and non target lesion assessment)
digital photo of tumor and other target lesions measurements
pre-treatment tumor and normal tissue biopsies

The following must be performed on Day 1 prior to drug administration:

CBC, serum biochemistry, urinalysis, coagulation profile
Plasma PK at time 0 and serum collection

Mammary tumor control cohort:

Tumor biopsy performed days 1, 8, and 15
Carboplatin chemotherapy administration, day 8
Blood, plasma, serum collection days 1, 8, and 15
Off study after day 15 evaluation

Dose escalation cohort:

Tumor biopsy performed days 1, 8, and 15
CBC/chemistry/UA/coagulation profile days 1, 8, 15, and 22
12-hour plasma PK, day 1
Blood, plasma, serum collection days 1, 4, 8, 11, 15, and 22
Iniparib administration (IV over 60 min) days 1, 4, 8 and 11
Carboplatin administration (IV bolus) day 11
Off study after day 22 evaluation
If progressive disease (PD) and symptomatic deterioration is documented at any point prior to this time, dogs may be removed from study and day 22 collections performed early.

Owner compensation will consist of the sponsor covering all study associated costs once enrolled in the study as well as provide clients with a $1,000 OSU-CVM account credit for any further veterinary care for their pet.

(Coming Soon)

1. Evaluation of Elesclomol pharmacokinetics in dogs with cancer. The purpose of this initial pilot pharmacokinetic study is to confirm the prolonged plasma exposure of STA-12-4049 in dogs with cancer prior to performing a larger study that would evaluate the biologic activity of Elesclomol in dogs with cancer.

2. COTC007b-Preclinical Comparison of Three Indenoisoquinolines Candidates in Tumor-Bearing Dogs is (1) dose escalation, tolerability, pharmacokinetic/pharmacodynamic study and (2) a cohort expansion at the maximally tolerated dose to extend the PK-PD profile of each agent. Study objectives are to distinguish the toxicity profiles of these agents and determine a difference in biological activity if one exists. This study will direct the conduct of further indenoisoquinoline evaluation. Lymphoma is one of the most common cancers in dogs, accounting for 7% to 24% of all canine cancers and having an estimated annual incidence of 13 to 24 cases per 100,000 dogs at risk. Although most dogs with lymphoma respond initially to current chemotherapy drugs, most eventually develop drug resistance. The indenoisoquinolines represent a new class of topoisomerase I inhibitors.

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