Clinical trials for dogs
The goal of this study is to determine if TK isoenzymes are good biomarkers for the early detection of HSA in dogs and to identify a threshold for detecting HSA from the presence of TK isoenzymes.
HSA is a malignant and rapidly growing cancer that is difficult to detect. HSA is a tumor derived from blood vessels, and thus the tumor is filled with blood. A frequent cause of death from HSA is the rupturing of the tumor, causing the patient to rapidly hemorrhage to death. HSA is common in dogs, and more so in certain breeds of dogs such as German Shepherds and Golden Retrievers. Dogs with HSA rarely show clinical signs until the tumor has become very large and has metastasized. Typically, clinical signs are due to hypovolemia after the tumor ruptures, causing severe bleeding. Owners of the affected dogs often discover that the dog has HSA only after the animal has collapsed secondary to bleeding. The HSA tumor often appears on the spleen, right side of the heart or liver.
There are currently no commercially viable screening mechanisms for detecting HSA in dogs. Most dogs present with HSA as emergencies and major decisions about treatment must be made without a definitive diagnosis. A screening test that would allow the detection of HSA would be very valuable in the planning of treatment and earlier detection of the disease. Preliminary data in dogs suggests that TK is significantly increased in dogs with some types of cancer, specifically HSA and thus TK may be useful in detecting, staging and monitoring disease in dogs with HSA.
Any dog (any age, sex or breed) with a hemoabdomen that undergoes exploratory surgery.
Dogs with pre-existing, previously diagnosed neoplastic conditions other than hemangiosarcoma will be excluded.
There are no direct benefits to the client. The indirect benefit is that this research will aid in the development of a point-of-care test for the diagnosis of hemangiosarcoma in dogs which will help owners of dogs with hemoabdomen make decisions regarding the best management for their dogs.
Dr. Claire Sharp
Phone: (508) 839-5302
To evaluate the effect of plavix dosing in respect to how much time is needed to achieve maximum platelet inhibition which may decrease risk of thrombeombolic disease.
Diagnosis of protein losing nephropathy, cases with high indices of suspicion without definitive diagnosis will also be considered.
Dogs will be excluded if they have received steroids or any anticoagulant medications.
May be able to use a lower dose of plavix, therefore, more cost-effective.
Diane Welsh, Clinical Trials Technician firstname.lastname@example.org
We have started a new study to evaluate the use of ultrasound as a quick and non-invasive method of measuring muscle mass in dogs. In many of the common diseases of dogs, such as heart failure, kidney disease, and cancer, a big problem that occurs is muscle loss. This muscle loss is important because it can make dogs weak and can negatively affect their quality of life. We have been studying methods of diagnosing and treating cachexia (the muscle loss that occurs with various diseases) for over 15 years. We are currently evaluating whether ultrasound, an non-invasive test, can be used to quickly and easily diagnose muscle loss in its early stages.
To be eligible, dogs must be healthy 1-5 year old, neutered dogs (male or female) of the following breeds:
*Cavalier King Charles Spaniel
Dogs must be purebred and should have no heart murmur or other medical problems.
Dogs with heart murmurs or any significant medical conditions
If eligible, the dog will get a free examination at Tufts, will have a small blood sample collected (less than ½ teaspoon; to measure red blood cell count, blood sugar, and an estimate of kidney function), an x-ray of the chest to measure bone size, and an ultrasound of the muscles over his or her back (no shaving required).
In addition to getting the free tests (blood test, x-ray, and ultrasound of the back muscles), this information will be beneficial in the future for dogs with heart disease, kidney disease, cancer, and other common diseases by validating an easy ultrasound test to measure muscle mass.
Dr. Lisa Freeman Phone: (508) 887-4696
This is a multi-center trial and the additional sites enrolling are:
- Veterinary Medical Center of Central New York, E. Syracuse, NY
- Colonial Veterinary Hospital, Ithaca, NY
- The Veterinary Cancer Center, Norwalk, CT
- VCA Animal Specialty Center, Yonkers, NY
- VCA South Paws Veterinary Specialists and Emergency Center, Fairfax, VA
- VCA Veterinary Referral and Emergency Center of Norwalk, Norwalk, CT
- VCA Katonah Bedford Veterinary Center, Bedford Hills, NY
- VCA Shoreline Veterinary Referral and Emergency Center, Shelton, CT
- VCA South Shore (Weymouth) Animal Hospital, South Weymouth, MA
Cancer is one of the most common conditions seen in older dogs and it is becoming more common for owners to opt to treat their pets with chemotherapy. Dogs undergoing chemotherapy may suffer from side effects of treatment such as vomiting, diarrhea, and reduced appetite. There are currently no commercial diets that are designed specifically to help support dogs with cancer undergoing chemotherapy by reducing the gastrointestinal side effects of chemotherapy.
The purpose of the study is to determine whether a specially formulated diet may reduce gastrointestinal side effects associated with chemotherapy and improve quality of life of dogs undergoing chemotherapy.
- Dogs > 1 year of age with multicentric lymphoma (LSA) and grade 2 or higher mast cell tumors (MCT) that will be treated with standard (non-metronomic) chemotherapy protocols at a participating study site.
- Weight > 5 kg, temperament suitable for drawing blood without sedation
- All dogs should be naïve to treatment for the current cancer, but can have been treated for other cancers in the past if greater than 1 year prior.
- Other diseases expected to potentially decrease quality of life, alter survival time, or limit diet options – e.g. significant heart disease, kidney disease, bad liver disease, etc.
- Current vomiting or diarrhea or a history of chronic vomiting or diarrhea (more than 6 multi-day episodes per year or one month of consistent clinical signs) within the last year that required medications or special diet for control
- Dogs with anticipated life expectancy of < 4 months
- Pet owner not willing to feed prescribed diet and limit treats to 5% of calories
Dogs will be fed either a high quality control diet appropriate for dog maintenance or the specially designed study diet – neither the pet owners nor the researchers will know which diet the dog is getting. Pet owners will need to fill out quality of life surveys as well as diet journals and fecal score journals every 1-2 weeks, and bring their dogs in for study visits/chemotherapy every 2 weeks. At three points during the study, blood and urine will be collected from fasted dogs.
Treats and dietary supplements will need to be restricted to only those provided on an approved treat and supplement list.
The study will cover the costs of all study-related blood work and visits. You will also receive free high quality pet food for the two month study duration and a $300 credit towards your account balance when you and your dog successfully complete the study and return all study-related paperwork. The study does not include the costs of cancer staging (including those required to determine study eligibility), or any costs associated with surgery or chemotherapy, additional blood work not required for the study, or follow-up visits outside of those described above. Your dog’s participation will also allow us to gain information which will help in the management of other dogs undergoing chemotherapy.
To make an appointment with the oncology department at Tufts, please call the oncology liason, Kelly Reed at 508-887-4682
To make an appointment at alternate sites offering this study, please contact that site directly:
Veterinary Medical Center of Central New York: http://www.vmccny.com/specialty.cfm?id=44
Colonial Veterinary Hospital: http://colonialvet.com/mast-cell-tumor-clinical-trial/
VCA Animal Specialty Center: http://www.vcaspecialtyvets.com/animal-specialty-center/departments-doctors/departments/oncology
The Veterinary Cancer Center: http://www.vcchope.org/resource-center/759
VCA South Paws Veterinary Specialists and Emergency Center: http://www.vcaspecialtyvets.com/southpaws/news/article/clinical-study-new-diet-for-dogs-undergoing-chemotherapy-for-lymphoma-or-mct/23244
For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: email@example.com
Title: Evaluating hypercoagulability in dogs with brachycephalic airway syndrome: similarity to human obstructive sleep apnea.
The primary purpose of the study is to determine whether English Bulldogs are more hypercoagulable than non-brachycephalic dogs by running a series of coagulation tests. We are also interested in determining if C-reactive protein, a marker of inflammation and cardiovascular risk, is elevated in English Bulldogs as it is in humans with obstructive sleep apnea.
English Bulldogs that have not undergone upper airway surgery and are currently exhibiting clinical signs consistent with the brachycephalic airway syndrome as documented by their owner (loud upper airway noise, snoring).
English Bulldogs that are between 2 and 8 years of age, any sex or weight.
English Bulldogs known to have a condition that will affect coagulation status, such as neoplasia, hemolytic anemia or thrombocytopenia.
English Bulldogs taking medication that may affect its coagulation parameters, such as non-steroidal anti-inflammatory drugs, warfarin, low molecular weight heparin, clopidogrel, aspirin, or prednisone.
English Bulldogs that have had surgical correction of their upper airway abnormalities (ie. Palatoplasty and rhinoplasty) to resolve/improve brachycephalic airway signs.
The study will cover the costs of routine bloodwork as well as coagulation tests and C-reactive protein analysis. Your dog’s participation will also allow us to gain information which will help in the treatment of other dogs with this condition.
For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: firstname.lastname@example.org
Description: Congenital heart defects occur in a variety of dog breeds, with the most common being the patent ductus arteriosus (PDA). Although this is a correctable disorder in most puppies, it requires surgery or a catheter-based procedure which can be expensive and is not without risk. Therefore, determining the genetic cause of PDA in dogs would be highly desirable so that dogs could be screened and the genetic mutation could be eventually bred out of the canine population. Corgis are a breed at increased risk for PDAs, so the goal of this study is to evaluate Corgis with and without PDAs in order to identify the gene mutation for this heart problem.
Pembroke Welsh Corgis with a documented PDA will be studied.
Breeds other than Pembroke Welsh Corgis.
The study will cover the cost of an echocardiogram (ultrasound of the heart) as well as a blood sample for DNA testing.
For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: email@example.com
Description: Acute radiation-induced dermatitis (ARID) is a common sequela of radiation therapy in both humans and dogs, arising in greater than 80-90% of patients undergoing definitive intent radiotherapy. Although relatively short-lived, skin reactions can be painful and itchy (which promotes secondary self-trauma in veterinary patients) and occasionally may necessitate dose reductions or treatment delays, which carry the potential to compromise tumor control. Another complication of radiation dermatitis is secondary infection. Although antibiotic use in the management of canine ARID is common practice amongst veterinary radiation oncologists, this management practice lacks evidence to support its use. The primary objective of this study is to evaluate the effect of prophylactic cephalexin antibiotics on rate of bacterial infection in ARID in dogs undergoing definitive-intent radiotherapy of the skin or subcutaneous tissues. Secondary objectives include characterization of the bacterial pathogens encountered in ARID as well as their antibiotic susceptibility.
- All dogs must have a histologically or cytologically confirmed skin or superficial soft tissue cancer, including soft tissue sarcomas, mast cell tumors, cutaneous melanoma, plasma cell tumors, infiltrative lipomas, and carcinomas.
- All dogs must be treated with definitive intent radiotherapy, defined as dose ≥45 Gy or higher.
- Prior surgery or chemotherapy is acceptable with a 2-week washout.
- Prior glucocorticoid therapy is allowed if the patient has been on this therapy for a minimum of 2 weeks prior to Day 0.
- Prior antibiotic therapy is acceptable within a 1-week washout from the start of radiotherapy.
- Dogs should be otherwise in good health, a candidate for daily anesthetic episodes, and must have adequate organ function as determined by blood work and urinalysis.
- Any homeopathic/alternative therapies for cancer must be discontinued prior to enrollment.
- Tumors located in the oral or nasal cavities, on the muzzle, or in the perineal region.
- Dogs that had a surgical flap procedure at the radiation site.
- Dogs that experienced a post-operative surgical infection.
- Dogs that require concurrent chemotherapy.
- Dogs that have received prior radiation therapy to the tumor site.
- Dogs that are currently on antibiotic therapy.
- Dogs with pre-existing dermatopathies.
The study will cover the costs associated with skin culture and impression cytology. In addition, the exam fee for the recheck at 1 week post-radiation therapy is at no cost. The client will be responsible for all other costs associated with the radiotherapy course as well as the cost of all medications. The client is expected to make and keep all appointments, according to the clinical trial protocol once enrolled.
Have a case?
Contact Dr. Michele Keyerleber at (508) 887-4682 or Michele.Keyerleber@tufts.edu
Recent studies in the human literature have documented that quicker lactate clearance is associated with improved survival in trauma patients. It is currently unknown if a similar trend exists in canine trauma patients. Our goal is to examine lactate clearance in canine trauma patients; samples will be taken at admission, and 2 and 4 hours after admission.
The purpose of the study is to determine whether lactate predicts how well dogs that have experienced trauma will do overall and whether or not they will need blood transfusions.
Dogs presenting with trauma (any kind) AND a lactate of ≥4 mmol/L at time of admission. Prior treatment is allowed.
Dogs presenting with trauma but having a lactate < 4 will be excluded; dogs that have a physiologic or pathophysiologic cause of hyperlactatemia that is not related to trauma will be excluded. Such patients could include those with neoplasia, those with hepatic disease, those who are taking steroids, or those which have had a seizure in the 6 hours prior to presentation.
The study will cover the costs of the three blood tests. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment of other dogs that have experienced trauma
Canine borreliosis has been associated with renal failure and death (“Lyme nephritis’) although causation remains speculative. The Ixodes tick in Northeastern U.S. transmits Borrelia burgdorferi, Anaplasma phagocytophilum, and Babesia microti. Babesia microti-like organisms have been associated with anemia, renal failure, and death in dogs in Spain. Babesia microti is known to infect humans and foxes in the Northeastern United States. We intend to investigate the incidence of babesial infection in dogs with signs suggestive of Lyme nephritis. We hypothesize that renal failure and death attributed to borrelial infection in dogs (“Lyme nephritis’) is due to infection or co-infection with a Babesia microti-like organism.
As a control group, we will be obtaining blood samples from dogs presenting to Tufts Foster Hospital for Small Animals for surgical repair of cruciate ligament disease for the presence of Babesia microti-like DNA.
Control dogs: Healthy dogs presenting for surgical repair of cruciate ligament disease.
The study will cover the costs of blood testing for Babesia microti-like infection, heartworm disease and exposure to the infectious organisms Ehrlichia canis, Anaplasma phagocytophilum and Borrelia burgdorferi. Your pet’s participation will also allow us to gain information which will help in the diagnosis and management of other patients.
Carcinomas are a common form of malignancy in both dogs and humans. As a category of cancer, carcinomas tend to be both locally invasive as well as carry a high risk of locoregional metastasis. In cases diagnosed in early stages, long term survival is often possible with a combination of surgery, definitive radiation therapy, and conventional chemotherapy, but such multimodality therapy is often cost prohibitive for many clients. Furthermore, surgery may not be an option for some patients. Therapy is often limited to palliative radiation therapy (PRT) +/- conventional chemotherapy. The purpose of this study is to evaluate therapy with toceranib (Palladia®), an oral anticancer agent, in combination with palliative radiation therapy for tolerability, toxicity, and efficacy in a population of dogs with measurable carcinomas.
1. Age: At least one year old on Day 0.
2. Body weight: Dogs must weigh at least 5.0 kg on Day 0
3. All dogs must have a histologically or cytologically confirmed carcinoma, including anal sac adenocarcinoma, ceruminous gland carcinoma, mammary gland carcinoma, nasal carcinoma, prostatic carcinoma, salivary gland carcinoma, sebaceous adenocarcinoma, squamous cell carcinoma, rectal carcinoma, thyroid carcinoma, or transitional cell carcinoma of the urethra.
4. The patient must have measurable disease at the primary tumor site and/or metastatic lymph nodes.
5. Prior surgery or chemotherapy is acceptable with a 2-week washout.
6. Prior NSAID therapy is allowed if the patient has been on this therapy for a minimum of 2 weeks prior to Day 0.
7. Dogs must have adequate organ function as indicated by standard laboratory tests: (hematology (CBC), clinical chemistry and urinalysis). Specifically, dogs must have:
a. Absolute neutrophil count (ANC) > 2,000 cells/μL
b. Hematocrit > 25%
c. Platelet count > 100,000/μL
d. Serum creatinine < 2.5 mg/dL
e. Bilirubin ≤ the upper normal limit
f. Transaminases ≤ 3 times the upper normal limit or if > 3 times the upper normal limit then serum bile acids must be ≤ the upper normal limit
8. The animal must have a performance status of either 0 or 1 on Day 0, according to the activity; 1, restricted [decreased activity from predisease status]; 2, compromised [ambulatory for only vital activities, urinates and defecates in appropriate areas]; 3, disabled [requires force feeding, unable to urinate and defecate in appropriate areas]; 4, dead.
9. The animal must be a fair to excellent anesthetic candidate for 10 daily anesthesias, defined as an anesthetic risk status of I to III on the following scale:
I. Excellent anesthetic risk: This includes normal, healthy patients.
II. Good anesthetic risk: This includes patients with mild systemic disease, such as geriatric or neonatal patients, localized or compensated disease.
III. Fair anesthetic risk: This includes patients with moderate systemic disease including those with low to moderate fever, moderate dehydration, anorexia/cachexia, chronic cardiac disease, chronic renal disease.
IV. Poor anesthetic risk: These patients have severe systemic disease that is a constant threat to life, including shock, high fever, toxemia, severe dehydration, severe anemia, diabetes, decompensated cardiac/renal/hepatic disease, severe pulmonary disease affecting gas exchange.
V. Guarded anesthetic risk: This includes moribund patients not expected to survive 24 hours including those with advanced multiorgan system failure, severe shock, DIC.
10. The owner must have provided written, informed consent prior to enrolling in the study.
1. Dogs with adrenocortical carcinoma, gastrointestinal carcinoma, hepatic carcinoma, pulmonary carcinoma, renal carcinoma, or transitional cell carcinoma of the urinary bladder.
2. Dogs that have received chemotherapy within 2 weeks of Day 0.
3. Dogs that have received prior radiation therapy to the tumor site.
4. Concurrent malignancy or other serious systemic disorder (renal disease, cardiac disease, respiratory disease) incompatible with this study.
5. Dogs that are on homeopathic/alternative therapies for their cancer. These should be discontinued on Day -1. Supplements such as chondroitin sulphate, essential fatty acids and glucosamine are permitted during the trial period.
6. Dogs with protein-losing nephropathy (UPC > upper limit ref range).
7. Dogs with an anesthetic risk status of IV or V on the above scale.
The study will cover the following costs associated with your participation in this clinical trial: the cost of Palladia for 12 weeks, $1250 towards radiation therapy, one set of chest x-rays (at week 12), and recheck exam fees at week 3, 4, 6, and 12 of the study. This amounts to a total financial benefit of approximately $2200. You will be responsible for general anesthesia and costs for the CT scan (if required); all radiation therapy costs beyond $1250; all costs associated with monitoring blood work and urinalyses during the study period and beyond; and any diagnostic tests (x-rays, abdominal ultrasound, etc.) and recheck exam fees beyond week 12. Your pet’s participation will allow us to gain information which will help in the treatment of other dogs with carcinoma.
Sponsor: Private Foundation
CSRC Protocol #: 030-14
Enrollment beginning in February 2015
The purpose of the study is to determine whether the administration of canine umbilical cord derived mesenchymal stem cells (UC-MSCs) is safe, and if it will reduce kidney injury to a greater extent than the current standard of care. The study will measure kidney values to see if they stay in or return to a normal range as well as overall survival. Secondarily, the study will monitor for any changes in your dog’s likelihood to form blood clots.
Dogs presenting with protein-losing nephropathy, hypoalbuminemia (<2.0 g/dl), azotemia (creatinine >2.0), thrombocytopenia (platelets < 160,000), and a hypercoaguable state.
Any gender, and any breed, weighing > 4 kg (8.8 pounds).
Able to come back for recheck appointments on days 2, 7, 14, 30 and 3, 6 and 12 months post injection.
Dogs weighing less than 4 kg (8.8 pounds)
Dogs not expected to live greater than 48 hours, those with cardiac disease, and those with neoplasia.
Also excluded will be those dogs with an active bacterial urinary tract infection, and those suspected or confirmed to have leptospirosis.
The study will cover some of the costs that are typically acrued in the diagnostic evaluation of dogs with protein-losing kidney disease including complete blood count, chemistry profile, urinalysis, urine culture, urine protein creatinine ratio, thromboeslatograph (a clotting profile), antithrombin level (to see if your dog is at risk for forming blood clots), ANA (looking for lupus, an autoimmune disease) , serology for tick borne diseases and leptospirosis. It will also cover an abdominal ultrasound examination and the cost of a kidney biopsy. Kidney biopsy is part of the standard diagnostic workup for dogs with protein-losing kidney disease permits it (not too anemic, platelet count adequate, and not hypertensive). The risks associated with kidney biopsy are blood loss from the biopsy site. Your dog will be monitored closely for 4 hours after the biopsy to make sure that any bleeding stabilizes. Heart rate, respiratory rate, mucus membrane color, and blood count will be monitored hourly. Should there be any evidence of sustained bleeding, your dog will be administered intravenous fluids and if needed a blood transfusion. The cost of the blood transfusion will be the responsibility of the owner. The study will also cover the cost for follow up blood work at the scheduled rechecks during the 365 days of the study. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.
Sponsor: Private Foundation
CSRC Protocol #: 026-14
Enrollment beginning February 2015
Dogs get a disease of the intestine called inflammatory bowel disease (IBD) in which the normal lining of the intestine is replaced by inflammatory white blood cells. This inflammation results in poor digestion, often manifesting as diarrhea, vomiting, and weight loss, and in some cases, loss of protein through the feces. This leads to a severe protein deficiency in the body, called a protein losing enteropathy (PLE). PLE is typically an indication of very severe intestinal inflammation and dogs with this condition may not respond well to typical medications used to treat IBD. In addition the PLE itself can cause fatal complications such as edema, fluid in the abdominal cavity, and blood clots. There is a need for new therapies to treat dog with PLE secondary to IBD. Based on evidence in the literature from pre-clinical and clinical trials in humans, we hypothesize that treatment of dogs with a PLE from IBD with stem cells isolated from the umbilical cords of dogs will modulate the inflammatory response in the intestine and induce clinical remission.
The purpose of the study is to determine whether intravenous administration of cells called mesenchymal stem cells can improve your dog’s clinical signs as well as their blood protein levels. It is believed that the benefit of these stem cells is related to their ability to suppress inflammation.
Dogs will have had incomplete response to therapy with prednisone, budesonide and/or cyclosporine (defined by a clinical score (CCECAI) >5), have intolerable side effects on medication, or have the administration of cyclosporine or chlorambucil be financially unreasonable for the owner, as these are the patients who require alternative therapeutic options.
Dogs with biopsy confirmed IBD and bloodwork confirmed panhypoproteinemia
(total protein <5.5 mg/dl) will be enrolled. The biopsies may be performed at Tufts if they are not already available for pathologist review.
Both male and female dogs weighing greater than 11 pounds and any age will be considered for the study.
Dogs with a urine protein:creatinine (UPC) ratio of >0.5, a baseline cortisol < 2 ug/dL, and a post- prandial bile acids of > 30 uM will be excluded from the study. This will eliminate dogs with protein loss through the kidneys, abnormal production of protein from the liver, or Addison’s disease. These tests can be performed at Tufts.
All dogs will have an abdominal ultrasound and those with signs of intestinal or extra-intestinal masses will be excluded.
Yorkshire Terriers, Soft-Coated Wheaten Terriers, and Boxers will be excluded, as these dogs have unique IBD features that respond differently from the general population of dogs.
Dogs with congestive heart failure, Cushing’s disease, diabetes mellitus, or cancer will also be excluded.
Expenses associated with giving the injection of stem cells and in evaluating your dog after the injection will be covered. Some initial testing, recheck examinations, and follow-up blood work will be covered. Your pet’s participation will also allow us to gain valuable information which will help in the management and treatment of other dogs with this condition.
The purpose of the study is to determine if increasing levels of the hormone progesterone found in the serum (bloodstream) of female dogs during their reproductive cycle leads to hypercoagulability (excessive blood clotting).
Female dogs will be recruited in the following groups.
1) Healthy, spayed females
2) Healthy intact female in anestrus
3) Healthy non-pregnant dogs in diestrus (estimated in 6-8 weeks post ovulation)
4) Healthy pregnant dogs (45-60 days pregnant)
5) Dogs during labor and delivery (C-section/dystocia)
6) Dogs with pyometra occurring during diestrus
The study will cover a test measuring progesterone levels and thromboelastography, a test that evaluates the entire clotting process in a patient. Your pet’s participation will also allow us to gain information which will help in the management and treatment in dogs with this condition.
Sponsor: Private Foundation
CSRC Protocol #: 027-14
Enrollment beginning February 2015
Currently, no medical treatments have been shown to delay the progression of chronic valvular disease (CVD) in dogs, which is a very common heart disease in dogs. In this disease, heart valves become thickened and can no longer keep blood from leaking backwards, leading to fluid accumulation in the lungs (congestive heart failure, CHF). Surgical repair of the valves has shown potential in reversing some changes from the heart disease and prolonging survival time, but this remains a relatively high-risk surgery that very few veterinary hospitals are capable of performing. The cost of the procedure is also financially prohibitive to most dog owners.
If we can show that mesenchymal stem cell (MSC) treatment is not only safe but can delay the progression of CVD in dogs, this would be the first non-surgical treatment option available to our canine patients. Our results would also have particular relevance for those human patients who cannot undergo valve repair surgery due to unacceptable anesthetic or surgical risks.
We hypothesize that MSC therapy is safe when administered intravenously (IV) to dogs in CHF, and MSC therapy will result in improved cardiac function as assessed by echocardiography, cardiac biomarkers, or the quality of life of the patient.
A total of 10 client-owned dogs of any sex or age with active CHF secondary to CVD to the Tufts Foster Hospital for Small Animals will be recruited for this clinical trial. Congestive heart failure will be confirmed on chest x-rays to verify the presence of pulmonary edema (fluid in the lungs).
Dogs with chronic kidney disease, liver disease, uncontrolled hypothyroidism, cancer, high blood pressure, active infection, metabolic disorders, and autoimmune disease will be excluded from the study.
The study will cover all of the costs associated with echocardiograms, chest x-rays, bloodwork analysis, blood pressures, ECG monitoring, and recheck exam fees. It will not cover the initial hospitalization cost for congestive heart failure stabilization. It will also not cover any medication costs or costs related to disease of other organ systems. Your pet’s participation will allow us to gain information which will help in the treatment of other dogs with this CVD and CHF. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.
Sponsor: Private Foundation
CSRC Protocol #: 029-14
Enrollment beginning in February 2015
Cardiomyopathy is a common affliction of the Boxer breed that is manifested by serious ventricular arrhythmias, dilation and reduced vigor of contraction of the heart, or both. The arrhythmic form of the disease bears a striking resemblance to arrhythmogenic right ventricular cardiomyopathy (ARVC) in people, an important cause of sudden cardiac death in young human athletes that is characterized by replacement of the normal heart muscle by fat, scar tissue, and inflammation.
Current treatment strategies focus on controlling symptomatic arrhythmias, however no medical treatment has been shown to prevent sudden cardiac death. Current therapies also fail to address the underlying structural changes in the heart muscle that inexorably progress, resulting in worsening arrhythmia, cardiac dilation and, in some patients congestive heart failure.
Mesenchymal stem cells (MSCs) exert anti-inflammatory and anti-fibrotic effects that may prove useful in attenuating the inflammation and remodeling of the heart muscle that characterizes the disease, in turn improving arrhythmia frequency and potentially quality of life or survival times of dogs with ARVC. The major goal of this study is to evaluate preliminary safety of intravenous administration of MSCs in Boxers with ARVC, and to assess their effect on arrhythmia frequency, improving cardiac structural abnormalities, or prolonging survival in affected animals by reducing inflammation or deposition of scar tissue in the heart.
A total of 12 client-owned Boxers of any sex or age with cardiomyopathy will be enrolled in this study. Dogs with advanced congestive heart failure, clinically significant congenital heart disease, kidney or liver disease, cancer, active infection, or autoimmune disease will be excluded from the study.
The study will cover the costs for your dog’s bloodwork, echocardiogram, blood pressure measurement, ECG and Holter monitoring, 4 hours of observation and continuous ECG monitoring following the injection, and recheck visits during the 6 month study period. The study will also cover up to $500 of any costs incurred due to complications from the study; it will not cover any other medication or hospitalization costs. Your pet’s participation will allow us to gain information which will help in the treatment of Boxers and potentially people with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment
In humans, massive hair loss (alopecia) from many chemotherapeutic drugs ranks among the most psychologically devastating side effects of cancer treatment. Conversely, in dogs, the development of alopecia is thought to be uncommon and is a poorly characterized event. Poodles and terrier breeds anecdotally are considered to be predisposed, although no sound data have been published on the hair loss. The mechanism of hair loss has been thoroughly investigated in humans, but not in dogs. The goal of this study is to describe the epidemiological, clinical and histopathological characteristics of doxorubicin-induced alopecia (DIA) in canine patients at Cummings School of Veterinary Medicine at Tufts University from 2012-current.
By understanding what populations of dogs are at risk for developing DIA, we hope to be able to better prepare dog owners of their risk for this potential chemotherapeutic side effect. In addition, we aim to compare DIA in the dog with chemotherapy-induced alopecia in humans and assess if the dog could be a good model for elucidating and preventing this devastating condition.
1. Treatment with doxorubicin
2. All follow-up appointments will be performed by Tufts Oncology rather than by the rDVM.
3. Breeds with coat types predisposed to developing DIA
Any systemic disease that might predispose increase risk with regards to the biopsy procedure (i.e., heart murmur, renal disease, brachycephalic breed).
The study will cover all of the costs of this study, with the exception of any possible complications to the anesthesia or the chemotherapy. Minor complications from the biopsy procedure (antibiotics or resuturing the wound) would be covered. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.
Lymphoma is a common cancer in dogs that can be treated with good success, but can rarely be cured. We are trying to develop new ways to prevent, diagnose, and treat lymphoma in dogs. To do this, we plan to study the molecular and cellular biology of canine lymphoma in the laboratory. For these studies, we need to collect small amounts of tissue from a lymph node affected by lymphoma.
Our goal is to collect canine lymph node, both normal and tumor-bearing (lymphoma) from dogs that present to the Foster Hospital For Small Animals for in vitro investigations of the biology and treatment of this disease. Samples will be collected either via post-mortem collection (normal or lymphoma), at biopsy (lymphoma), or using a fine needle aspirate (lymphoma).
Normal Lymph nodes:
1. Dogs that are euthanized at the FHSA and the body is available for donation or necropsy.
1. Dogs with metastatic cancer, systemic infectious or inflammatory disease will be excluded.
1. Any dog with newly diagnosed, suspected, or relapsed lymphoma.
2. The owner consents to sample collection.
Exclusion (For premortem sample collection) –
1. Dog objects strongly to FNA or restraint and will not be sedated for other procedures.
2. Concern for coagulopathy based on:
a) Physical or historical evidence of petechia, unexplained bleeding or hematomas.
b) Laboratory or historical evidence increased risk for hemorrhage including thrombocytopenia < 50,000/ul
There is no monetary compensation for participating in the study nor is there any charge associated with the procedures. The most important benefit to participation is that these studies may help dogs in the future by allowing us to find better ways to prevent, diagnose and treat lymphoma.
Description: The purpose of this study is to better understand what causes gastric dilatation and volvulus (GDV) in dogs. GDV, or bloat, is a common condition in large and giant breed dogs. Due to the importance of GDV in many dog breeds, several large previous studies have investigated potential risk factors for the development of GDV.It is known that there is no single cause for GDV, rather its occurrence is multifactorial, with both genetic and environmental factors contributing. As well as a genetic analysis we want to see if dogs with GDV have different types or amounts of proteins, hormones and other molecules in their blood and tissue, or different bacteria in their gastrointestinal tract.
We will enroll dogs in five groups:
- Dogs with acute GDV
- Dogs with chronic bloat and/or gastric instability
- Dogs with acute gastric outflow or small intestinal obstruction secondary to foreign material
- Healthy control dogs
- Euthanized control dogs; and
- Euthanized dogs with GDV or gastrointestinal foreign body obstruction
Group a) Dogs with Acute GDV
Inclusion criteria: Dogs with GDV confirmed via a right lateral abdominal radiograph
Exclusion criteria: none
Group b) Dogs with chronic bloat
Inclusion criteria: Clinical signs consistent with chronic bloat
Exclusion criteria: GDV at any time
Group c) Dogs with acute GI obstruction secondary to foreign material
Inclusion criteria: Dogs with GI obstruction secondary to foreign material that require exploratory laparotomy.
Exclusion criteria: History of GDV. GI perforation., Non-obstructive foreign body that does not require surgery
Group d) Healthy control dogs
Inclusion criteria: Healthy
Exclusion criteria: History of GDV
Group e) Euthanized control dogs
Inclusion criteria: Euthanized donated dogs
Exclusion criteria: History of GDV
Group f) Euthanized dogs with GDV or GI foreign body obstruction
Inclusion criteria: Dogs that will be euthanized after a diagnosis of GDV confirmed via a right lateral abdominal radiograph, or GI obstruction secondary to foreign material confirmed via abdominal radiographs or ultrasound.
Exclusion criteria: Surgical treatment of GDV or GI obstruction
This study will not cover any of the costs associated with treating your dog; although all study related sample collection and analysis is covered by the study. As such, the cost of treatment is the same regardless of whether your dog is enrolled in the study. Your dog’s participation will allow us to gain information which will help us to develop a better understanding of why some large and giant breed dogs develop GDV.
Sponsor: Private Foundation
CSRC Protocol #: 007.15
Enrollment anticpated to begin June 2015
The goal of this study is to develop a new treatment for perianal fistulas in dogs. The current treatments for this severe condition (steroids and cyclosporine) are ineffective in a high percentage of patients and the disease relapses frequently. Also, cyclosporine is expensive and has many side effects, so a major goal is to develop a therapy which reduces the need for immunosuppressive agents, such as cyclosporine. Previous trials using intralesional injections of stem cells have shown very encouraging results.
- Adult dogs, any breed and either gender, with a clinical diagnosis of anal fistulas (presence of chronic peri-anal fistula(s) with clinical signs of tenesmus, dyschezia)and present with partial or complete relapse from cyclosporine A therapy
- Age range 1-12 years
- Weight range 2-100 kg
- Dogs younger than 1 year or older than 12 years
- Other severe diseases ( severe osteoarthritis, cardiac disease, neoplasia, skin disease)
- Dogs that have had surgery (cryosurgery, anal sac resection, tail amputation) to treat the anal fistulas
The study will cover all the costs of the examinations (once your dog is found eligible) and stem cell treatments including sedation. The study will provide $300 to participants toward purchase of cyclosporine during the 1 year study.
Sponsor: Private Foundation
IACUC protocol#: G2015-56
The goal of this study is to evaluate biomarkers in urine as measures of cardiac health. Specifically, we will compare extracellular miRNA (‘micro RNA’) content of urine from healthy dogs, dogs with mitral valve disease, and dogs with renal disease (see criteria below).
These studies will improve our knowledge of how extracellular miRNA reflects damage to the heart, versus damage from heart medications to the kidney.
There will be four populations in this study:
Group 1: Healthy adult dogs (8+ years) with no cardiac disease (no murmur)
Group 2: Dogs with mitral valve disease and not in congestive heart failure
Group 3: Dogs with mitral valve disease in congestive heart failure
Group 4: Dogs with kidney injury but without cardiac disease (azotemia and no heart murmur)
The owner’s participation in this study will allow us to gain information about the benefits of using urine (a readily available, non-invasive source) to screen for heart disease and associated renal damage. In addition, the biomarkers (signals) we find may help veterinarians determine the effectiveness of treatments in their patients over time. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.
Sponsor: Private Foundation
IACUC protocol#: G2015-58 Currently Recruiting
The goal of this study is to compare plasma biomarkers in the form of extracellular RNA in dogs with mitral valve disease presenting with versus without congestive heart failure.
This study will be an important step towards making exosome analysis a useful and readily available tool for evaluating the progression, the molecular basis for remodeling, and development of specific therapies for mitral valve disease.
All dogs should be over eight years of age in order to control for age related differences.
Healthy: for controls the dogs will be defined as a healthy animal with a normal physical exam, normal CBC/chemistry panel/UA and no evidence of a heart murmur as documented by a veterinarian
There will be four populations that will be included in this study:
- Group 1: Healthy dogs with no cardiac disease
- Group 2: Dogs with mitral valve disease not in congestive heart failure.
- Group 3: Dogs with mitral valve disease in congestive heart failure.
Sponsor: Private Foundation CSRC Protocol#: 002.15 Recruitment beginning July 2015
Cardiomyopathy is a common affliction of Boxer dogs that is manifested by serious ventricular arrhythmias, cardiac dilation and reduced pump function, or both. The arrhythmic form of the disease bears a striking resemblance to arrhythmogenic right ventricular cardiomyopathy (ARVC) in people, an important cause of sudden cardiac death in young human athletes that is characterized by replacement of the normal heart muscle by fat, scar tissue, and inflammation. ARVC can be challenging to diagnose. Genetic testing is imperfect and ARVC screening usually entails a combination of family history, genetic testing, electrocardiographic and echocardiographic findings.
The development of blood-based cardiac biomarkers has revolutionized the way in which we screen for certain types of heart disease. MicroRNAs (miRNAs) are small non-coding RNAs that play important roles in modifying gene expression. MiRNA gene expression patterns are altered in several types of cardiac disease in people and miRNA-based therapeutics are an area of active research. MiRNAs are uniquely suited to serve both as non-invasive biomarkers of disease and also potential therapeutic targets.
The goals of this pilot study are twofold: 1) to determine the feasibility of measurement of miRNAs from circulating exosomes in canine peripheral blood samples; and 2) to compare expression patterns of candidate miRNAs between normal Boxers and Boxers affected with ARVC. We hypothesize that measurement of miRNAs from within exosomes circulating in canine plasma will be feasible, miRNA will be enriched in the exosome rather than the non-exosomal fractions, and furthermore that Boxers affected with ARVC will have altered miRNA expression patterns relative to age- and breed-matched healthy controls.
16 Boxers – 8 Normal, 8 with ARVC
Normal boxers: > 5 years of age
< 50 VPCs/24 hr on Holter monitor
Boxers with ARVC: Any age with ≥500 VPC/24 hr on a Holter monitor or
Ventricular ectopy sufficiently severe to begin antiarrhythmic therapy
Dogs with ACVIM Class C or D congestive heart failure, and those with clinically significant congenital heart disease, advanced renal or hepatic disease, diabetes mellitus, malignant neoplasia, active infection, or autoimmune disease will be excluded from the study.
Administration of antiarrhythmics or other cardiac medications deemed necessary by each dog’s clinical condition will not preclude enrollment in the study.
The study will cover the costs for your dog’s bloodwork, echocardiogram, ECG, and Holter monitor today. Your pet’s participation will also allow us to gain information which will help in the diagnosis and treatment of other Boxers with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.
The primary goal of this study is to evaluate the efficacy of diphenoxylate hydrochloride plus atropine sulfate (Lomotil) as treatment for diarrhea in dogs receiving treatment with toceranib phosphate (Palladia) for cancer. Toceranib is an increasingly commonly used drug in veterinary oncology since it was approved by the Food and Drug Administration in 2009. Diarrhea is often a dose-limiting side effect and negatively impacts patient quality of life.
To date, there are no standard or evidence-based protocols for supportive care to mitigate the adverse events while patients receive toceranib. Toceranib is being used with increasing frequency in veterinary oncology, but this treatment is associated with a relatively high rate of adverse events. The most common adverse event described is diarrhea, which can lead to drug holidays and dose reductions. If diphenoxylate + atropine is effective at controlling diarrhea, it is anticipated that more dogs would be able to receive appropriate doses that reliably achieve therapeutic drug levels with fewer drug holidays, thereby enhancing tumor control while preserving good quality of life
Canine patients presenting the Foster Hospital of Small Animals who will be prescribed toceranib at a target dose.
- History of chronic diarrhea
- Gastrointestinal upset (nausea, vomiting, diarrhea, inappetence) within three days prior to the start of toceranib
- Patients may not have received any medication for nausea or diarrhea within 7 days of starting toceranib
- Patients may be on concurrent medications associated with gastrointestinal toxicity (prednisone, NSAIDs, cyclophosphamide) as long as they have been on the medication for at least two weeks without gastrointestinal upset.
- Patients receiving monoamine oxidase inhibitors will be excluded due to possible drug interactions
- Creatinine above the upper limit of the normal reference range
- Alanine aminotransferase (ALT) >3 times the upper limit of normal, icterus or increased bile acids
The study will cover the cost of the anti-diarrhea medication and the examination fee at the 4-week recheck visit. You are responsible for the cost of the initial consultation, 2-week recheck examination, all blood tests and Palladia. Your pet’s participation will also allow us to gain information which will help in the management of other dogs with similar disease.
Acute traumatic coagulopathy (ATC) is a recognized phenomenon in human medicine following severe trauma. The etiology of coagulopathy is likely multifactorial and may include the effects of platelet dysfunction and factor consumption, shock, hypothermia, acidemia, systemic inflammation from tissue trauma, and hemodilution. Hyperfibrinolysis has been identified in severely injured human patients and has been associated with both tissue injury and shock. This overt coagulopathy affects at least 25% of severely traumatized human patients and is directly correlated to injury severity, massive resuscitation, and transfusion requirements. Humans with ATC are known to have a worse outcome than those with similar trauma and the same injury severity score and no disorder of coagulation. Identification of ATC in human trauma patients is a predictor of devastating complications including multi organ failure, sepsis and death.
Early identification of these patients will enable clinicians to better counsel owners regarding prognosis and help them make difficult decisions regarding treatment. Also, identification of hyperfibrinolysis in trauma patients will enable further clinical studies to be conducted regarding early anti-fibrinolytic therapy, a readily available and inexpensive medication.
Dogs weighing > 5 kg (10 pounds) presenting to the Emergency Service following acute trauma with evidence of shock and or long bone fractures will be included. Dogs that develop instability (shock) following admission for treatment or management for their trauma can also be included.
The study will cover the cost of initial ER blood testing and all the clotting tests performed. Your pet’s participation will also allow us to gain information which will help in the diagnosis and management/treatment of other dogs with severe trauma in the future.
Description: Cystotomy is among the most common surgical procedures performed in our canine patients. Despite the frequency of the surgery, no study has been done to document the post-operative appearance of the urinary bladder. This investigation will be invaluable to veterinarians in evaluating cases with surgical complications such as bladder wall dehiscence, reactive inflammation to suture material, or other related clinical concerns.
The main objective of this study is to describe the ultrasonographic appearance of the urinary bladder incision site immediately after a cystotomy and in the days and weeks that follow as the bladder recovers to determine a normal course of bladder healing. This description would include serial bladder wall thickness measurements at the surgical site and at other sites of the bladder wall. Adhesions, remaining sediment or stones, blood clots, recurrence of masses, and other notable findings will be reported.
Dogs presenting with cystoliths for surgical removal.
Prior history of bladder surgery.
The potential benefits that your dog shall receive from participating in this study include: multiple free ultrasounds to provide more information to the surgeon and veterinarians managing your dog’s condition, both preoperatively and in the critical postoperative period. Participation may provide valuable information about the extent of your dog’s disease and therefore influence the course of treatment to help your dog. Your dog’s participation will also allow us to gain information that will help in the management of other dogs with this condition in the future. The cost of the ultrasound examinations will be covered by the study, but no further compensation will be given for participation in the study
Sponsor: Private Foundation
CSRC Protocol #: 009.15
Enrollment beginning September 2015
Atopic dermatitis (AD) affects approximately 10% of the canine population globally and is likely the most prevalent skin disease in the dog requiring medical intervention. Current treatment options for canines include antihistamines, corticosteroids, cyclosporine A, oclacitinib, and allergen-specific immunotherapy (ASIT) administered subcutaneously or sublingually, as well as adjunctive treatments such as topical and systemic antimicrobial therapy. Avoidance of implicated allergens is impractical or impossible in most cases. The problem with the above treatment options is that they are not entirely reliable therapeutic modalities, have potential for adverse reactions, or they come with significant financial burden. There is a great need for finding a novel, safe, and effective treatment for the management of canine AD.
Multipotent mesenchymal stem cells (MSCs) have been extensively evaluated in human medicine for their clinical applications in the repair of damaged tissues and in the treatment of chronic, degenerative inflammatory diseases because of their diverse wound healing and anti-inflammatory properties.
Our primary goal is to investigate the safety and biological activity of canine placental (fetal) derived MSCs in alleviating the clinical signs associated with canine atopic dermatitis. Our secondary goal is to investigate the feasibility of this protocol for future applications in larger scale randomized controlled double-blinded clinical trials.
- Males or females, neutered or intact, greater than one year of age
- Have a minimum body weight of 5 kg
- Have a diagnosis of AD made based on history, clinical signs, exclusion of all other pruritic disease, meeting the de facto established criteria by Willemse and Prelaud. Cutaneous adverse food reaction will have been ruled out using a novel protein elimination diet trial for 8 weeks with no subsequent change in pruritus level following a provocation trial.
- Must be on and remain on ectoparasite preventatives for the duration of the trial.
- Dogs with other systemic diseases (severe osteoarthritis, cardiac disease, neoplasia, skin diseases) apart from atopic dermatitis will be excluded
- Inadequately treated skin infection
The study will cover all of the costs associated with this study. If an adverse event, such as an allergic reaction should occur, the study would cover the cost of treatment up to a limit of $500; adverse reactions or other complications will be managed by our ICU staff.
Your pet’s participation will allow us to gain information, which will help in the diagnosis/management/treatment of other dogs/cats/horses/others with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.
The success of cardiopulmonary resuscitation (CPR) is very low, in veterinary (as well as human) patients. Even after successful return to spontaneous circulation, sequela to CPR include repeated cardiac arrest, brain disease, and multi-organ system failure. Low oxygen levels to the brain is the major factor contributing to these poor outcomes. There is a critical gap in our understanding of the physiology and prognosis after CPR, which has led to failure to substantially improve our success in dealing with this problem.
An important goal of this study is to understand how chemicals called nucleic acids (RNA) are altered in post-CPR canine patients. The study will focus on very small RNA (miRNA). The specific objective of this study is to understand which miRNA are released into the circulation of canine patients after cardiopulmonary resuscitation (CPR) versus non-CPR patients hospitalized in the ICU for other reasons.
There is tremendous potential value in identifying circulating miRNA after CPR. First, miRNA may assist in predicting outcome (prognosticating) in individual patients in the future. Second, miRNAreleased into the circulation are indicators of major epigenetic disturbances as a consequence of hypoxia-ischemia. Knowledge of these miRNA may lead to the design of novel therapies to counteract these effects, for example employing stem cells that release mitigating miRNA.
Group 1: Six dogs that have undergone CPR according to standard protocols in the TCSVM emergency room and have returned to spontaneous circulation for a minimum of 1 hr.
Group 2: Six dogs hospitalized in the ICU that have not experienced CPR or significant hypoxemia or ischemia (e.g. GDV, hemorrhage, stroke) will be selected for sampling at the same time (AM vs. PM). Dogs will be similar age and gender as post-CPR patient.
Any breed is acceptable.
- Dogs < 10 kg
- Dogs with prior hypoxemia insult (prior arrest or CPR, GDV, stroke, hemorrhagic shock, congestive heart failure, etc).
- Dogs with a diagnosis of cancer
- Dogs with hemolytic disease
- Dogs for which blood sampling is contraindicated (recent fluid/colloid resuscitation)
The study will cover the cost of a blood panel (NOVA) at the same time the sample is being collected; this is testing that is normally performed every few hours during recovery from CPR, it is also testing that is normally performed in sick dogs. Your pet’s participation will also allow us to gain information which will help in the treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment
What is osteoarthritis?
Osteoarthritis (OA) is a progressive degenerative disease of the joints. The body parts making up the joint become worn out and can be swollen, stiff, and painful. Osteoarthritis is a common condition in dogs. Signs of osteoarthritis often develop slowly. Dogs may develop increased stiffness, especially after rest, or during cold weather. Dogs with osteoarthritis pain may become less active during play, during walks, when going up or down stairs, or jumping. These can be signs of osteoarthritis, and can reduce the quality of your pet’s life.
Objective of the clinical trial:
The objective of this study is to evaluate the efficacy and safety of two investigational drugs in dogs diagnosed with pain due to osteoarthritis of joint(s) of the legs (shoulder, elbow, hip, and knee).
What qualifies my dog for enrollment in this in this trial?
To participate in this clinical trial, your dog must have:
• Diagnosis of pain due to osteoarthritis of joint(s) in hind and/or forelimb(s). At least one joint must be affected.
• Dogs at least two years of age and weighting between 15-50 kg at visit 1.
• Generally healthy dogs with no evidence of other serious chronic disease.
• Owner must be able and willing to comply with the visit schedule, dosing instructions and other responsibilities during the study.
• Must have been on the same diet for at least one month before visit 1, and remain on same diet throughout study.
Other specific inclusion and exclusion criteria will be used to determine eligibility for enrollment.
What does enrolling my dog in this clinical trial involve?
If your dog qualifies for the study, and you agree to participate, your dog will be randomly assigned to one of four treatment groups. You will be required to administer study medication twice daily for approximately 14 days, as capsules that are given to the dog by mouth. Each dog will receive, either an investigational drug, carprofen (a traditional non-steroidal anti-inflammatory drug) or a placebo. Treatment groups will be is randomly assigned. Neither you, nor the veterinarian, will know your dog’s treatment group.
All study procedures, including the study’s required radiographs (and associated sedatives if needed), office visits, and laboratory tests are provided free of charge. In return for your dog’s enrollment and your participation in the study, you will be eligible to receive a $150 Visa gift card provided your dog is not withdrawn due to non-compliance and you complete the study. If your dog is withdrawn due to other factors, you would be compensated for the portion for the study you did complete.
The purpose of the study is to determine the safety and efficacy of a novel anti-cancer agent, BKM120 in dogs with non-Hodgkin’s lymphoma. This drug is unique in that it targets a particular pathway that is often abnormal in many types of cancer, including lymphoma. BMK120 has been shown to have efficacy in treating numerous human cancers with an acceptable safety profile.
If you decide to participate in this study, your dog will be treated by a group of veterinarians specializing in clinical cancer research. Blood specimens and biopsy samples are an integral part of the treatment program and will be done at intervals at the recommendation of the veterinarian in charge and in accordance with the study protocol. As part of a cancer clinical trial, it is important to obtain information about the effectiveness of the drug therapy given to your dog.
- Species: Canine / various pure and mixed breeds
- Sex: male and female, intact and neutered
- Age Range: at least one year old on day 0
- Weight Range: greater than 10 kg on day 0
- Dogs diagnosed with histologically or cytological confirmed B or T cell lymphoma leukemia are eligible to be enrolled. The patient may have failed standard therapy or there may be no other known effective antineoplastic therapeutic options, or the owner may elect to enter the patient in lieu of standard therapy (e.g. Dogs will offered participation in this trial if they failed conventional therapy or if the owner is unable or not interested in pursuing conventional therapy).
- All dogs must have a histologic or cytologic diagnosis of lymphoma confirmed. Documentation through immunohistochemistry, immunocytochemistry or flow cytometry, or monoclonal immunoglobulin gene rearrangement by PCR for antigen receptor rearrangement must be performed. These tests are routine/standard of care, but immunophenotyping is not always completed since it is not necessary for treatment. If immunophenotyping has not been previously completed, then the investigators may provide funds for the necessary testing.
- Dogs with confirmed diabetes.
- Dogs that have received chemotherapy within 1 week of Day 0.
- Dogs that have received radiation therapy within 3 weeks of Day 0.
- Use of any other investigational drug within 1 week of study entry.
- Concurrent malignancy, other than NHL, or other serious systemic disorder incompatible with this study.
- Dogs receiving homeopathic/alternative therapies for their NHL – unless these therapies are discontinued on or prior to Day -1. Supplements such as chondroitin sulphate, vitamins, essential fatty acids and glucosamine are permitted during the trial period.
- Concurrent use of complementary or alternative medicines that in the opinion of the principal investigators would confound the interpretation of toxicities and/or antitumor activity of the study drug.
The study will cover all of the costs associated with your participation in the clinical trial including examination fees, blood work, biopsy fees, anesthesia, immunophenotyping (if indicated) and cost of study drug. Your pet’s participation will allow us to gain information, which will help in the treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.