Dogs

Clinical trials for dogs

  • Sponsor: Private Foundation

    IACUC protocol#: G2015-58                                                                                                                                 Status:  Currently enrolling

    Description:

    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.

    Inclusion/exclusion criteria:

    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.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Status:  Currently enrolling

    Description:

    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.

    Inclusion Criteria:

    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.

    Exclusion Criteria:

    • 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)

     

    Client Benefits:

    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

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

  • Sponsor: Private Foundation

    CSRC Protocol #: 117.15

    Enrollment: currently enrolling

    Description:

    Dogs presenting with acute, concussive disk herniations share many similarities with human spinal cord injury patients. The prognosis for return to normal function is very guarded in dogs with acute onset of paraplegia and loss of pain perception in hind legs. The likelihood to regain ambulatory status is within the range of 43-69%. Fecal incontinence was observed in 41% and urinary incontinence in 32% of dogs regaining pain perception and ambulatory function. In dogs which fail to regain pain perception and ambulatory function after surgery, fecal and urinary incontinence will persist and frequent urinary tract infections are common. In addition, in some dogs this dysfunction can progress to the level of ascending urinary tract infection and sepsis.    New therapies are needed to improve these outcome.

    We propose to transplant allogeneic Wharton’s Jelly (umbilical cord matrix) mesenchymal stem cells (WJ-MSC) into the spinal cord of dogs admitted to the Foster Hospital at Cummings Veterinary Medical Center at Tufts University because of severe spinal cord injury secondary to intervertebral disc herniation/compression in order to study their potential as neuroprotective and regenerative agents.

    Our hypothesis is that chondrodystrophic dogs with an acute onset of paraplegia and loss of pain perception caudal to a thoracolumbar disk extrusion treated with decompressive surgery and subdural allogeneic WJ-MSC will have a significantly higher likelihood of a functional recovery than dogs treated with decompressive surgery alone.

    In this prospective study, paraplegic dogs with absent pain perception will be randomly assigned to WJ-MSC (in Cryostor) plus surgery or vehicle (Cryostor) plus surgery. Parameters of interest include time to return of pain perception, motor function, ambulation and urinary/fecal continence. A successful outcome will be defined as return to ambulatory function, normal pain perception caudal to the lesion and full urinary and fecal continence within 3 months post-surgery.

    A positive functional outcome as a result of stem cell transplantation would be a tremendous benefit and step forward for dogs being affected with concussive disk herniations. Determining such efficacy, along with an assessment of any related complications, would provide an ideal naturally occurring disease model in dogs could also be utilized in human therapeutics of spinal cord injury.

    Inclusion Criteria:

    Dogs of any age, sex weighing less than 25 kg with the following:

    ° Complete medical history

    ° Owner consent for inclusion into study

    ° Paraplegia with absent pain perception in hind legs and tail at admission

    ° Extradural compression between T3 – L3 diagnosed with CT or MRI

    ° Acute disk extrusion confirmed at surgery

    ° Follow up performed at Cummings School of Veterinary Medicine at Tufts University by neurology service

    Exclusion criteria:

    ° Unable to confirm disk extrusion intraoperatively

    ° Concurrent disease that could interfere with neurologic recovery

    ° Inability to obtain in-hospital follow-up performed at Tufts University by the neurology service

    ° No owner consent

    Client benefits:

    The study will cover all of the costs of stem cells treatment and follow-up appointments up to 3 months after the surgery, as well as contribute $1100 towards the cost of surgery. 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.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Status:  Currently enrolling

    Description

    Bisphosphonates, such as pamidronate and more recently zoledronate, are commonly used for palliation of pain related to malignant osteolysis. Acute systemic inflammatory responses, cardiac arrhythmias, ocular toxicity and significant elevations in pro-inflammatory cytokines have been observed in association with bisphosphonate therapy in humans, although the frequency is uncertain. The primary objective of this study is to investigate if there is an increase in biomarkers of inflammation and myocardial injury after zoledronate administration in dogs with malignant osteolysis. A secondary objective is to assess body temperature and to determine if there is an association between zoledronic acid-induced rise in temperature and elevation in inflammatory biomarkers.

    Inclusion Criteria

    • All dogs must be at least one year old on Day 0.
    • All dogs must weigh at least 5kg on Day 0.
    • All dogs must have complete baseline cancer staging involving physical exam, chemistry profile and urinalysis prior to enrollment.
    • Dogs must have adequate organ function as indicated by standard laboratory tests: hematology (CBC), clinical chemistry and urinalysis.
    • All dogs must have either radiographic or advanced imaging to confirm the presence of a lytic bone lesion.
    • All dogs must be intended to receive intravenous zoledronate to alleviate associated bone pain as part of their therapeutic plan.

     Exclusion Criteria

    • Dogs that had received prior bisphosphonate (pamidronate or zoledronate) administration.
    • Evidence of severe kidney dysfunction.
    • Dogs that are receiving corticosteroids for at least 7 days prior to enrollment.

    Client Benefits

    The study will cover the costs associated with one administration of one dose of zoledronate, three CBCs, and the costs of blood tests involved in the study. This amounts to a total financial benefit of approximately $550.  The client will be responsible for all other costs associated with the cancer staging (initial consult, chemistry profile, urinalysis, and radiographic or other advanced imaging evidence of a lytic bone lesion) as well as any additional treatments with zoledronate or other cancer therapy during and after completion of the study. Each patient’s participation will allow us to gain information which will help in the side effect management of future dogs undergoing treatment with zoledronate.

    Have a case?  

    Contact Drs. Michele Keyerleber or Molly Holmes at (508) 887-4682, Michele.Keyerleber@tufts.edu or Molly.Holmes@tufts.edu            

  • Status:  Currently enrolling

    Description:

    The purpose of the study is to investigate ways to monitor dogs that have been diagnosed with chronic inflammation in their liver so called chronic hepatitis in dogs. We are performing this study to evaluate whether these blood tests correlate with the severity of the dog’s liver disease.

    Inclusion Criteria:

    • Dogs weighing greater than 6 kg (13 lbs)
    • Dogs with histologically confirmed chronic hepatitis

    Exclusion Criteria:

    • history of use of corticosteroids, ursodeoxycholate, NSAIDs, omega-3 or vitamin D supplementation within 2 weeks of enrollment or the use of DDAVP within 24 hours
    • degenerative mitral valve disease, renal disease (Creat >2.0 mg/dL), concurrent active infection, neoplasia, IBD, immune mediated hemolytic anema, pnacreatitis or immune mediated polyarthropathy

    Client Benefits:

    The study will cover the costs of the vitamin D, CRP and von Willebrand factors as well as a complete blood count and serum chemistry at the first recheck appointment.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

     

     

  • CSRC protocol #: G2016.33

    Status:  Currently enrolling

    Description:

    To determine if telmisartan, a medication used to reduce protein loss through the kidneys, is broken down and processed differently in dogs with kidney disease compared to healthy dogs.

    To compare the ability of telmisartan to control protein loss through the kidneys in dogs with protein-losing kidney disease (protein-losing nephropathy, or PLN) with benazepril, one of the medications in the class of medications (angiotensin-converting enzyme inhibitors) that is currently standard therapy for this disease.

    We hypothesize that the processing of telmisartan in dogs with PLN will be altered compared to the patterns previously established in healthy dogs, and that telmisartan will be equally or more effective than benazepril at treating PLN.

    This study serves to evaluate telmisartan, a medication commonly used in human medicine, for its role in helping to treat protein-losing nephropathy, a potentially devastating disease in dogs.  If successful, this may open a new option for treatment of dogs with PLN who don’t respond to standard therapies, such as benazepril.  In addition, the pharmacokinetics of telmisartan (or any angiotensin-receptor blocker) in dogs with PLN has not been previously evaluated.

    Inclusion Criteria:

    Dogs who have been diagnosed with protein-losing nephropathy (as defined by having a urine protein:creatinine ratio >2.0 with no evidence of non-renal causes of proteinuria).

    Client benefits:

    The direct benefit from this study for your dog is that he or she will receive one of two promising therapies for protein-losing kidney disease with close monitoring of his or her response to therapy.  The direct benefit to you is that the costs of either medication (benazepril or losartan) will be covered for the duration of the study (6 months).  You will be responsible for the costs of the preliminary diagnostic tests (including ultrasound) and the costs of the recheck appointments and urine and blood testing at these rechecks.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

     

  • Status: Currently enrolling

    Description:

    The goal of this study is to measure the presence of a blood marker, miRNA, in dogs with naturally occurring bone cancer (osteosarcoma) and compare these results to healthy unaffected dogs. We hypothesize that the presence of this biomarker will positively correlate with the presence of tumor and high expression levels may be associated with outcomes of disease-free interval and survival time in dogs with osteosarcoma.  Approximately 10 mls (2 teaspoons) of blood will be collected from your dog’s vein via routine blood sampling. Blood collection ideally will occur both prior to and following removal of your dog’s tumor. This is a safe amount of blood that can be sampled in any dog greater than 5 kilograms.

    Inclusion Criteria:

    Dogs with osteosarcoma weighing 5 kilograms (11 pounds) or greater

    Client Benefits:

    Your pet’s participation will 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.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • CSRC Protocol # 110-16

    Status: Currently enrolling

    Description:

    Our overall goal is to measure the incidence of vomiting, gastroesophageal reflux (GER) and regurgitation in dogs after pre-anesthetic administration of acepromazine and dexmedetomdine . These complications can potentially result in severe esophageal damage and aspiration of stomach contents causing pneumonia .

    This study will allow us to identify the most efficient drug regime that reduces the incidence of GER and regurgitation during anesthesia in particular in those patients more predisposed to gastrointestinal complications. The study will also allow us to institute early treatment with antiemetics and gastrointestinal protectants once GER is detected. It is also our aim to raise awareness in regards to these potential complications.

    Inclusion Criteria:

    Healthy dogs that are scheduled to undergo an elective soft tissue or orthopedic procedure that are:

    • 6 months to 8 years of age
    • Male or female
    • weighing 5 kg (11 lb) to 35 kg (77 lb)

    Exclusion Criteria:

    • Dogs will be excluded from this study if they have vomited or regurgitated within a week of the scheduled elective soft tissue or orthopedic procedure .
    • Dogs will also be excluded if the randomized treatment does not provide enough sedation to place an intravenous catheter in a safe and ethical manner.

    Client Benefits:

    Participation in the study will allow us to identify peri-operative regurgitation and reflux earlier than if your pet was not included in this study. If there is evidence of regurgitation during the procedure, your animal will be promptly treated (suction and/or esophageal wash). This study will also provide data of the occurrence of perioperative reflux which would not be otherwise identified. The information will be considered in the postoperative management of your pet. Your pet's participation will also  allow us to gain information which will help in the management of other dogs in the future that undergo general anesthesia

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

     

     

     

  • IACUC Protocol # G2016-135

    Status: Enrollment on hold

    Description: 

    To evaluate the effects of cyclosporine treatment in naturally occurring atopic dermatitis (eczema or skin disease) in dogs. Cyclosporine is an approved and commonly used drug for this disease, and the proposed study will evaluate immune (reaction and interaction of drugs with the body) and pharmacologic (actions of the drug) responses to the drug to help understand why some dogs respond more strongly than others to the medication.

    Inclusion/Exclusion Criteria:

    Inclusion: Dogs must be diagnosed by the dermatology service with atopic dermatitis, and must be recommended to receive cyclosporine therapy for at least 30 days. Long-term cyclosporine administration is one treatment option for atopic dermatitis that is considered standard of care.

    - Age range 1-14 years

    - body weight ≥5kg

    Exclusion:

    - Patients cannot have previously received cyclosporine

    - Patients cannot have been treated with oral/topical steroids or oclacitinib (Apoquel) within the past 2 weeks, or long-acting steroid injections within the past 6 weeks.

    Client Benefits:

    As part of the study, you will receive a free 1 month recheck with our dermatology service. Cost of the blood draw will also be covered by the study. Participation in the study will be incentivized by offering $100 towards the purchase of cyclosporine.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • CSRC protocol # 003.17

    Status:  Currently enrolling

    Description:

    Gallbladder mucoceles (GBM) are a common and significant cause of biliary disease in dogs.  We hypothesize that dogs with GBM will have coagulation parameters compatible with a hypercoagulable state. We hope to determine if there is a correlation between these coagulation parameters and known risk factors for mortality in dogs undergoing cholecystectomy for GBM, clinical course and ultrasonographic findings associated with gallbladder rupture.

    Inclusion criteria:

    • Ultrasonographically diagnosed gallbladder mucocele (GBM).
    • Dogs must have had a complete blood count, chemistry and urinalysis within 24 hours of the ultrasound diagnosis
    • Body weight greater than 5 kg

    Exclusion criteria:

    • Administration of vitamin K, blood productions or any other medications known to affect coagulation (nonsteroidal anti-inflammatory medications, corticosteroids, heparin, clopidogrel, free fatty acids or hydroxylethyl starch) within 2 weeks of the sample collection
    • Greyhounds will be excluded

    Client Benefits:

    The study will cover the costs of coagulation testing (prothrombin time, partial thromboplastin time, factor VIII activity, fibrinogen, Ddimer, thromboelastrography, protein C activ ity, antithrombin activity and von willebrand factor activity). We will share the results of the thromboelastography with you. The other coagulation tests will not be performed immediately. Your pet's participation will also allow us to gain information regarding the coagulation status in dogs with gallbladder mucoceles which may help in the management of other dogs with this condition. You understand that your animal's participation in this study may not alleviate or cure his/her ailment.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

     

     

  • IACUC Protocol # G2016-161

    Status: Currently enrolling

    Description:

    To develop tests to measure lymphocyte function in healthy animals, which will then be able to be used to monitor disease in sick dogs and rabbits. Lymphocytes are a type of white blood cells that function as part of the immune system. Normally, they respond properly to foreign invaders in the body. When the lymphocytes do not act properly diseases may occur.

    Once adequately developed and validated, the proposed tests will allow us to evaluate immune function in dogs and rabbits with diseases affecting their immune systems. The various applications of these tests include evaluating rabbits with Encephalitozoon cuniculi, an infection also affecting humans, and measuring the effects of immune suppressing drugs taken by both dogs and humans.  To be able to measure immune responses in sick patients, we must first develop the tests in blood from healthy animals.

    Inclusion Criteria:

    Healthy dogs weighing more than 5 kg and between the ages of 1 and 12

    Healthy rabbits weighing more than 1 kg and between the ages of 1 and 6

    Exclusion criteria:

    Dogs: weighing < 5 kg

    < 1 year old or > 12 years old

    Pregnant

    Rabbits: weighing < 1 kg

    < 1 year old or > 6 years old

    Pregnant

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • IACUC protocol #: G2017-28

    Status:  Currently enrolling

    Description:

    Immune-mediated hemolytic anemia (IMHA) is an important disease in dogs that causes anemia (a low red blood cell count). We would like to be able to identify how a patient is responding to therapy using a blood test.  We hope to identify how long it takes to see suppression of the immune markers in a blood sample during therapy and see if this varies by treatment regimen used.  We will be looking at three different  lymphocyte responses during treatment for IMHA. Our goal is to identify if one of these markers decreases more rapidly in response to immunosuppressive treatment, and if one treatment is best associated with patient survival at 1 month.

    Inclusion Criteria:

    Dogs diagnosed with immune-mediated hemolytic anemia weighing more than 6 kg.

    Client Benefits:

    As part of the study, you will receive a free 2 and 4 week recheck with our Internal Medicine service. Cost of the blood draw will be covered by the study, as will the cost of the recheck red blood cell test (PCV).

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Sponsor: Private Foundation

    Status:  Currently Enrolling

    Description:

    Acute spinal cord injury affects thousands of people and numerous veterinary patients each year.  Intervertebral disc disease (IVDD) can cause movement of the disc that lives between the bones of the spine. This movement can press on the spinal cord and cause compression, resulting in a common cause of acute spinal cord injury in veterinary patients and leads to lack of function in the legs. This disease requires surgery to remove the disc that is compressing the spinal cord to try to reverse the loss of function in the legs. It can also cause bruising of the spinal cord or lack of blood flow, which cannot be reversed by surgery. Numerous studies have shown that the amount of function lost, most severely with the loss of sensation in the toes, is the best way to predict how a patient will recover after surgery with a 50% chance of recovery. However, why half of these patients recovery and the others don't recover or worsen is not clear at this time . Additionally, in disease processes where compression is not the main cause of injury and the bruising or lack of blood flow (ischemia) is the main cause of clinical signs, few studies have been conducted to determine prognosis. There are other diseases beside IVDD that can also lead to ischemia of the spinal cord and there is no treatment available to reverse these signs.

    An important goal of this study is to understand how chemicals called nucleic acids (RNA) are altered in canine patients after acute spinal cord injury. The study will focus on microRNA (miRNA), as these chemicals tell the body how to adapt after an injury or illness and can be targeted to help change the way our bodies respond through medications or therapies. They can also help aid our understanding of how humans and animals will recover from diseases. The specific objective of this study is to understand the quantity of specific miRNA, which are released into the cerebrospinal fluid (CSF, the fluid that lives around the brain and spinal cord) of canine patients after acute spinal cord injury (ASCI) versus non-ASCI patients undergoing sampling of the CSF for diagnosis of their disease.  Additionally, we aim to determine if plasma and CSF miRNA content differs within and between patient groups. .

    Client Benefits:

    The study will cover all the costs associated with the CSF tap, including the procedure and the fluid analysis.  The CSF will benefit the diagnosis and treatment of your dog by supplementing our workup and can help us determine the chances of recovery for your dog.  Your pet's participation will also allow us to gain information which may help in the diagnosis, management and treatment of other dogs with this condition in the future.  You understand that your animal's participation in this study may not alleviate or cure his/her ailment.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

     

  •  

    IACUC protocol: G2017-69

    Status: enrolling

    Description:

    The purpose of the study is to identify the dose and potential anti-cancer activity of DF2156A, a new drug that blocks the signaling of a key substance that helps tumor avoid the immune system.   DF2156A is an oral drug that works by blocking the receptor for a cytokine called IL-8. In the current study, dogs with cancer will receive increasing doses of DF2156A to identify a dose that is sufficient to inhibit IL-8 receptor, while also being tolerable over a 2 month period of dosing.  The clinical trial will also follow all dogs to determine whether shrinkage of tumors occurs in any cases.

    Inclusion criteria:

    • Dogs diagnosed a solid tumor including carcinoma, sarcoma, melanoma or mast cell tumor are eligible. The dog 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.
    • Dogs must be at least 1 year of age and weigh at least 10 kg.
    • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
    • Dogs must have an estimated life expectancy of at least 28 days.
    • Prior chemotherapy or radiation must be completed at least 1 week prior to study entry and the patient must have recovered from the acute toxicities of these treatments.
    • Informed written consent obtained
    • Owner must be able to orally administer drug according to designated schedule.

    Exclusion Criteria:

    • Pregnant or lactating dogs
    • Dogs with active autoimmune disease.
    • 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.
    • Dogs with significant cardiovascular, hepatic or renal disease.
    • Less than 2 weeks from a major surgical procedure.
    • Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).
    • Use of any other investigational drug within 1 week of study entry.

    Client Benefits:

    All costs associated with participation in this study, including the treatment of any study-related side effects, are covered by the study.  If a dog is doing well on the study at day 56 (final visit) and there is sufficient DF2156A supply, continued therapy beyond this point in time may be permitted.  However, all costs for recheck exams and necessary blood tests will no longer be covered.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  •  

    IACUC Protocol: G2017-86

    Status: Enrollment complete

    Description:

    Determining how best to combine new cancer treatments with existing cancer treatments is a critical step in helping to improve outcomes. We have found that a combination of the novel drug KPT-9274 and the standard chemotherapy agent doxorubicin works quite well for the treatment of canine lymphoma.  This study will help to find the most effective way to combine these two drugs by testing three different approaches to giving them together.  Results of this study will be used to help design future human and dog clinical trials with KPT-9274 and chemotherapy with the ultimate goal of improving outcomes for both species.

    Inclusion criteria:

    • Dogs newly diagnosed with T or B cell lymphoma are eligible. Dogs must be at least 1 year of age.
    • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
    • Dogs must have an estimated life expectancy of at least 21 days.
    • Dogs must not have received any prior therapy for the lymphoma.
    • Informed written consent obtained
    • Owner must be able to orally administer drug according to designated schedule.

    Exclusion criteria:

    • Pregnant or lactating dogs
    • Dogs with uncontrolled autoimmune hemolytic anemia (AIHA) or immune mediated thrombocytopenia (ITP) are not eligible.
    • Dogs with evidence of significant bone marrow, gastrointestinal or hepatic involvement.
    • 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.
    • Dogs with significant cardiovascular disease.
    • Less than 2 weeks from a major surgical procedure.
    • Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).
    • Dogs that have received any prior therapy

    Client Benefits:

    The study will pay for all costs including all visits and any the costs associated with any drug related adverse events (e.g., medications, hospitalization, etc). Owners will cover the costs of any non-study related adverse events (e.g., ear infection, etc.). If a dog is doing well on the study at day 29 (final visit) and there is sufficient KPT-9274 supply, continued therapy beyond this point in time may be permitted. However, the costs for recheck exams and necessary blood tests will no longer be covered. At the end of the study, a $500 credit will be available at the Foster Hospital for Small Animals for continued treatment of your dog should you choose to pursue other therapies.For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • IACUC protocol: # G2017.82

    Status: currently enrolling

    Description:

    IMP is a protein involved in stimulating the immune system. The expression of this protein is often low in tumors and is thought to be one of the reasons why the immune system does not do a better job at recognizing and killing tumor cells. The purpose of this clinical trial is to determine whether injecting a small piece of DNA that causes expression of the IMP protein in dog sarcomas can induce a local immune response that results in the destruction of tumor cells. Data generated from this study will provide new information regarding the potential therapeutic value of IMP therapy and ultimately may lay the groundwork for future clinical trials of this agent.

    Inclusion Criteria:

    • Dogs diagnosed with cytologically or histologically confirmed spontaneous soft tissue sarcoma amenable to repeat biopsy are eligible for enrollment. The dog may have failed standard therapy (surgery, chemotherapy, radiation therapy), or there may be no other known effective therapeutic options, or the owner may elect to enter the dog in lieu of standard therapy.
    • Dogs must be at least 1 year of age and a minimum of 10 kg in body weight.
    • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
    • Otherwise medically healthy with no clinically significant physical findings upon examination, medical history, and clinical laboratory profile, as deemed by the Principal Investigators.
    • Dogs must have an estimated life expectancy of at least 28 days.
    • Prior chemotherapy or radiation must be completed 2 weeks prior to Study entry and the patient must have recovered from the acute toxicities of these treatments.
    • Informed written consent must be obtained

    Exclusion Criteria:

    • Pregnant or lactating dogs
    • Evidence of brain metastasis
    • Concurrent use of complementary or alternative medicines that in the opinion of the Principal Investigator would confound the interpretation of toxicities and/or antitumor activity of the Study Drug.
    • Dogs with significant liver or cardiovascular disease.
    • Less than 2 weeks from a major surgical procedure.
    • Any serious systemic disorder incompatible with the Study (at the discretion of the Principal Investigator).
    • Use of any other investigational drug within 2 weeks of Study entry.

    Client Benefits:

    All costs associated with participation in this study, including the treatment of any study-related side effects, are covered by the study.  Additionally, a $2,000 credit will be provided at the Foster Hospital for Small Animals for removal of the tumor and/or additional therapy (local radiation, etc.) after study completion.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

     

  • IACUC Protocol: # G2017-80

    Status: enrollment currently on hold

    Description:

    In both human beings and dogs, local tumor recurrence following surgical removal of solid tumors is a major cause of treatment failure. An important technical limitation is that there is currently no widely available technique for rapid evaluation of the completeness of tumor removal during surgery. To address this need, a handheld imaging device has been developed that can be used in conjunction with injectable fluorescent imaging agents that accumulate in cancerous tissue and are administered to the patient prior to surgery.  The imaging device can be used to scan the tumor bed for residual tissue to identify cancer that has not been removed. Removing this tissue has potential to reduce local recurrence rates.  The objective of this project is to test the accuracy of the system in distinguishing normal tissue from cancerous tissue in dogs undergoing resection of carcinomas, a common category of cancer in dogs.   We hypothesize that the system will have a high level of accuracy in this application.

    Inclusion Criteria:

    Any dog with naturally occurring mammary, anal sac, liver, thyroid or lung carcinomas.  Informed client consent will be obtained prior to entering dogs in the study.

    Exclusion Criteria:

    Patients with mammary tumors will be considered candidates for the study only if their tumors can be appropriately treated with a standard mass removal as opposed to unilateral or bilateral mastectomy.

    Client Benefits:

    You will receive a $500.00 reduction in your total bill as an incentive to participate in this study, and you will not be charged for your initial office visit. Your pet’s participation will allow us to gain information that will help in the treatment of other dogs, cats, and humans undergoing surgical resection of malignant tumors.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials office: clinicaltrials@tufts.edu

     

     

     

     

  • Protocol# G2017.35

    Status: Currently enrolling

    Description:

    Acute kidney injury (AKI) is a serious state in dogs, cats as well as in humans that is underdiagnosed due to a lack of diagnostic tools. This study is designed to test whether newly developed biomarkers correlate with declined kidney function in dogs. We hope to find biomarkers that detects kidney injury at an earlier stage compared to the ones currently being used, thus helping us to identify and treat patients at an early stage in order to improve outcome.

    Inclusion criteria:

    • Dogs that are likely to develop an AKI due to e.g. intoxications, sepsis, heatstroke
    • Dogs that are acutely azotemic (have elevated BUN and creatinine values) due to e.g. leptospirosis, intoxications, pyelonephritis, sepsis, heatstroke
    • Body weight greater than 4.5 kg

    Exclusion criteria

    • A known history of kidney disease

    Client Benefits:

    The study will cover the costs of blood work, including complete blood count, chemistry and Snap 4DX plus (test for vector- borne diseases) and urinalysis for the first four days of hospitalization, then every second day until discharge from hospital. It will also include free control visits at 4 weeks and 3 months from discharge with the laboratory work listed above.

  • Status:  Currently enrolling

    Description:

    Poor control of the glucose levels in diabetic dogs can alter how the drugs behave in the body, which can result in drug toxicities. The changes in blood proteins caused by diabetes can significantly affect the disposition of the many protein-bound drugs used in diabetic patients. This study will explore a model that will allow identification of changes in protein binding that will improve the safety of giving different medications to diabetic patients. This study has the potential to help diabetic dogs to receive appropriate medical care and have a better quality of life.

    Inclusion Criteria:

    Well diabetic adult dogs that weigh at least 3 kg (6.6 lbs) of any age and breed will be included in the study.

    Exclusion Criteria:

    Sick dogs, those receiving drugs known to be highly protein bound, and hypoalbuminemic dogs will not be included in the study.

    Client Benefits:

    The study entails having 2-3 teaspoons (12-15 ml) of blood drawn from your dog.  As an incentive, the study will cover the cost of a blood chemistry profile that would be performed as part of your dog's visit.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials office: clinicaltrials@tufts.edu

     

     

     

     

     

     

  • Status: Currently enrolling

    Description:

    This clinical trial led by the National Cancer Institute (NCI) and sponsored by the Morris Animal Foundation evaluates the safety and effectiveness of ADXS31-164c when given to dogs with osteosarcoma after receiving standard of care treatment. Standard of Care is defined as definitive surgery, defined as amputation of the affected limb, followed by 4 doses of intravenous carboplatin chemotherapy given on an every 21 day schedule. Carboplatin has been safely and effectively used to treat appendicular osteosarcoma in dogs for more than 20 years, but the potential for unforeseen potentially life-threatening side effects from surgery, chemotherapy, and/or progressive cancer does exist.

    Bone cancer or osteosarcoma (OSA) is a common, highly aggressive cancer that frequently affects the long bones of large breed dogs. Current therapy consists of limb amputation plus chemotherapy. However, despite therapy, most patients die as a result of the cancer spreading to other parts of their bodies. The immune system plays an important role in identifying and targeting cancer cells in the body. In this study, we aim to use a new approach to stimulate the body’s own immune system to attack remaining tumor cells in dogs that have undergone limb amputation and chemotherapy for the treatment of OSA. We will use a vaccine made from the bacteria Listeria monocytogenes, which has been genetically modified to express a tumor protein (HER-2/neu) that is found in many cancer cells, including canine bone cancer cells and cancer stem cells. When injected into the bloodstream, the modified Listeria stimulates the immune system to attack cells expressing the HER-2/neu tumor protein. This approach aims to delay and/or prevent the spread of cancer (metastases) following removal of the primary bone cancer tumor (limb amputation) and chemotherapy.

    Inclusion Criteria:

    • Histologically or cytologically (consistent with a mesenchymal neoplasm) confirmed appendicular osteosarcoma, which includes all long bones of the limbs (radius, humerus, ulna, scapula, femur and tibia), but excludes metatarsus, metacarpus, carpal and tarsal bones, and digits.
    • Measurable disease that is amenable to surgical removal via amputation (No evidence of metastasis based upon physical exam, thoracic radiographs, and abdominal ultrasound).
    • Favorable performance status: Grade 0 or 1 (modified ECOG criteria)
    • ONLY newly diagnosed dogs are eligible with no prior therapy (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates) for osteosarcoma
    • Informed owner consent for trial
    • Dogs must undergo full post-mortem examination (necropsy) if they die while on study

    Exclusion Criteria:

    • Dogs < 25 kg in size post amputation
    • Dogs without measurable disease (appendicular osteosarcoma) at presentation to Tufts
    • ANY prior therapy for osteosarcoma (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates)
    • Concurrent medications deemed incongruent with this study. All pre-existing necessary medications should be recorded as concomitant medications.
    • Significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure or clinical coagulopathy
    • Creatinine > 2.0 mg/dL
    • Bilirubin > 2.0 mg/dL or elevated bile acids
    • HCT < 25%, platelets < 100,000 cells/ul
    • UP:C> 2.5
    • Any hematologic/biochemical (excluding ALT or ALP-detailed below) abnormalities > grade 1 (VCOG-CTCAE).
    • Dog will be eligible as long as liver ALT is equal or less than 2.5x normal reference range IF patient has been managed with NSAID therapy at the time of presentation. If no current usage of NSAIDs, eligibility will remain the defined 1.5x normal reference range.
    • Total ALP elevations less than 5-fold increased upper reference range, in the concurrent absence of significant ALT elevations (Grade I (1.5xULN) or less), will be acceptable for inclusion into study.

    Client Benefits:

    Some but not all costs associated with this study will be provided as part of your participation. The study will cover the appointment fee on the days when carboplatin chemotherapy is administered as well as for chest x-rays performed prior to the third and after the fourth dose of carboplatin.  The costs associated with amputation and carboplatin chemotherapy (drug, administration fees, laboratory tests, and ancillary medications) remain the responsibility of the pet owner who has signed below.  The study will cover the cost of appointment fee, vaccine and administration, antibiotics and monitoring tests for each of the three vaccinations.  In the event, any complications arise from ADXS31-164c administration, their management will be covered by study funds up to $500/per dog.  This would include any unanticipated hospitalizations. Please discuss the treatment and study costs with your clinician.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  • CSRC protocol # 115.16

    Status: Currently enrolling

    Description:

    The goal of this study is determine if a human stem cell-based therapy can be used to treat perianal fistulas, a condition that occurs in dogs but also occurs in some humans suffering from Crohn’s Disease. The current treatments (steroids and cyclosporine) are ineffective in a high percentage of patients and the disease relapses frequently. Also, cyclosporine is very expensive and has many side effects. We want to investigate if human stem cells (hESC-MSCs) injected in the fistulas can induce remission of the diseaseSpecifically, we would like to determine if a second injection of hESC-MSCs can close any fistulas that may re-appear after the initial closure of fistulas (ie, if the effects of the first injection wear off). The hESC-MSC can have some advantage compared with autologous stem cells, for instance, namely: (1) ease of use (no need to extract bone marrow, high numbers easily generated in the lab); (2) well defined and constant property (no variability) (3) higher anti-inflammatory properties. The trial is therefore of high interest not only for this specific disease but also for other diseases that may benefit from treatment with hESC-MSCs in humans.

    This trial is also being conducted at Massachusetts Veterinary Referral Hospital in Woburn, MA

    Inclusion Criteria:

    Adult dogs (either gender, any breed) 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.

    Exclusion Criteria:

    Dogs younger than 1 year or older than 12 years will be excluded; dogs with other severe diseases (severe osteoarthritis, cardiac disease, neoplasia, skin diseases) apart from anal furunculosis will be excluded. Dogs that had surgery (cryosurgery, anal sac resection, tail amputation) to treat the anal fistulas will not be included.

    Client Benefits:

    Once enrolled, all costs associated with this study (e.g., cyclosporine, sedation medication, stem cell treatment, check-ups, blood draws) will be covered for the duration of the follow-up period (i.e., for 6 months after the last MSC injection). Treatment related complications (such as localized infection, allergic reaction) will be covered up to $1000 by the sponsor. Costs incurred due to unrelated complications will not be covered. Your pet's participation will also allow us to gain information which will help in the diagnosis of other dogs with this condition. You understand that your animal's participation in this study may not alleviate or cure his/her ailment.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • Status: Currently enrolling

    Description:

     To evaluate ampicillin pharmacokinetics in dogs with mild to moderate kidney disease. This study will help establish dosing recommendations for an important class of antimicrobials in dogs with kidney disease. It will also give insight into the variability of renal clearance in dogs with mild to moderate kidney disease, and how high ampicillin blood concentrations become in this subset of dogs.

    Inclusion criteria:

    • Body weight greater than 6kg
    • Blood creatinine levels between 2-4 mg/dL on NOVA or Istat due to acute kidney injury, acute on chronic kidney disease, or chronic kidney disease that are being prescribed ampicillin or ampicillin + sublactam.

    Exclusion criteria:

    • Known comorbidities such as neoplasia, congestive heart failure, or those suspected to have Addison’s disease based on a supportive sodium potassium ratio.
    • Dogs which are likely to have fluid responsive azotemia based on a USG > 1.020 prior to fluid administration.

    Client Benefits:

    The study will cover the costs of the sampling catheter and serum chemistries at hospitalization and 24 hours later. Your pet’s participation will also allow us to gain information regarding ampicillin dosing in dogs with mild to moderate kidney disease.

    Contact Information: 

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • IACUC protocol # G2018.33

    Status: Currently enrolling

    Description:

    Acute kidney injury (AKI) is common in dogs and is associated with high morbidity and mortality. How to enhance kidney recovery is the main question in the management of our patients that develop AKI. Monitoring of treatment response is currently based on serum creatinine levels, a biomarker of kidney function.

    The aim of this study is to describe urinary Neutrophil-­‐Gelatinase-­‐Associated Lipocalin (uNGAL), urinary NGAL to Creatinine Ratio (UNCR) and serum creatinine in dogs recently diagnosed with AKI and follow their progression during the first 3 days of therapy.

    The ultimate goal of our study is to determine if uNGAL and/or UNCR as a biomarker of kidney damage will provide a better assessment of kidney recovery and a better monitoring tool for the treatment response in every day clinical practice in comparison with serum creatinine levels.

    Inclusion criteria:

    -­‐ Dogs either presenting to our hospital or hospitalized patients that develop AKI within 48 hours of monitoring.

    -­‐ The dogs will have to have a urine analysis and culture prior to any antibiotic treatment

    -­‐ Dogs already started on any type of treatment for less than 24 hours will be included.

    -­‐ The dogs will require hospitalization for at least 3 days after the diagnosis of AKI and initiation of treatments.

    -­‐ Body weight greater than 5 kg.

    Exclusion criteria:

    -­‐ Dogs with AKI diagnosed/already treated for more than 24 hours.

    -­‐ Dogs with AKI related to post-­‐renal obstruction or neoplastic infiltration.

    Client Benefits:

    The study will cover the costs of the additional daily serum creatinine (measured every 12 hours for 3 days instead of every 24 hours), the costs of the urine creatinine measured every 12 hours for 3 days and the costs of the urinary NGAL measured every 12 hours for 3 days. These tests will not be performed immediately. Your dog’s participation will allow us to gain information regarding the levels of this new biological marker which may help in the management of other dogs with this condition in the future. You understand that your animal’s participation in this study will not improve or  cure his/her condition.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • IACUC Protocol # G2018-22

    Status: Enrolling

    Description:

    The purpose of this clinical trial is to evaluate the activity of new formulation of an old chemotherapy drug called paclitaxel in dogs with mast cell tumors.  Paclitaxel is not water soluble and therefore needs to be formulated with a chemical that permits intravenous administration.  ART207 is a new formulation of paclitaxel in which the drug is encapsulated in a lipid (fat) protein complex designed to promote specific uptake of the complexes through cholesterol receptors that are expressed in tumors.  ART207 results in much higher exposures to paclitaxel than the previous formulations and may have greater anti-tumor activity in dogs with cancer.

    The ultimate goal of this clinical trial is to shrink your dog’s mast cell tumor by using a novel formulation of paclitaxel that selectively targets the tumor cells, thereby reducing systemic side effects. As paclitaxel is known to have activity against mast cell tumors in dogs, it is likely that ART207 will have equivalent or superior activity to paclitaxel given its higher drug exposures.

    Inclusion Criteria:

    • Dogs must have a cytologic or histopathologic diagnosis of mast cell tumor. The dog 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.
    • Dogs must have measurable tumor at least 2 cm in size or greater
    • Dogs must be greater than 1 year of age
    • Dogs must weigh at least 5 kg
    • Dogs must have adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
    • Dogs must be medically healthy with no clinically significant physical findings upon examination, medical history, and clinical laboratory profile, as deemed by the principal investigators.
    • Dogs must have an estimated life expectancy of at least 28 days.
    • Prior chemotherapy or radiation must be completed 2 weeks prior to study entry and the patient must have recovered from the acute toxicities of these treatments.
    • Informed written consent must be obtained
    • Dogs must be able to return for study visits as dictated by the study calendar

    Exclusion Criteria:

    • Pregnant or lactating dogs
    • Any abnormality on the CBC or chemistry panel deemed to be significant by the principle investigator
    • 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.
    • Dogs with significant liver, cardiac and/or renal disease
    • Less than 2 weeks from a major surgical procedure.
    • Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).
    • Use of any other investigational drug within 1 week of study entry.
    • Dogs with evidence of systemic mast cell disease (i.e., spread to the liver, spleen, bone marrow, etc).

    Client Benefits:

    The study will cover all diagnostics (bloodwork, imaging, biopsies, etc) and treatments (ART207 administration, supportive medications) associated with the mast cell tumor while your dog is enrolled in this study as well as the management of any study related side effects. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the mast cell tumor are your responsibility.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

     

     

  • IACUC # G2017.129

    Status: Enrolling

    Description:

    The purpose of this clinical trial is to evaluate the activity of new immunotherapy agents for the treatment of osteosarcoma that has spread to the lungs.  The ultimate goal is to find drug combinations that either stop the growth of tumor spread or that actually shrink the spread by stimulating the immune system to control the cancer.

    Your dog will undergo several blood tests/diagnostics prior to and during the course of treatment to monitor blood counts and collect plasma/blood for additional genetic analyses. These blood draws amount to approximately 2 tbsp. of blood at each visit. Your dog’s treatment for osteosarcoma will involve the administration of two drugs orally at home to help control the cancer: toceranib (Palladia) and losartan. Palladia received FDA approval to treat mast cell tumors in dogs in 2009. Since then it has been used to treat several types of cancer in dogs. Losartan is a generic version of a drug called Cozaan which is used to treat high blood pressure in people. Both drugs have been tested extensively in dogs with cancer either alone or in combination to ensure that the dose being given is safe.

    Inclusion Criteria:

    - At least one year old on Day 0.

    - All dogs must have had surgical resection of the primary tumor with a histologically confirmed diagnosis of OSA.

    - All dogs must have measurable pulmonary metastatic disease, documented by thoracic radiographs.

    - Prior chemotherapy (or other specific therapy for OSA) or any other anti-cancer therapy is acceptable with a 2-week washout from prior treatment.

    - Dogs must have adequate organ function as indicated by standard laboratory tests: (hematology (CBC), clinical chemistry and urinalysis).

    - The animal must have a performance status of either 0 or 1 on Day 0, according to the modified ECOG Performance Scheme.

    - The Owner must have provided written, informed consent prior to enrolling in the study.

    Exclusion Criteria:

    - Dogs that have received chemotherapy within 2 weeks of Day 0.

    - Concurrent malignancy, or other serious systemic disorder incompatible with this study.

    - Dogs that are on homeopathic/alternative therapies for OS. These treatments should be discontinued on Day -1. Supplements such as chondroitin sulphate, vitamins, essential fatty acids and glucosamine are permitted during the trial period. Pain medications such as opioids and NSAIDs are permitted at the discretion of the clinician, provided they were also administered prior to the development of metastases

    Client Benefits:

    The study will cover all diagnostics (bloodwork, x-rays, etc) and treatments (oral drugs) associated with the osteosarcoma while your dog is enrolled in this study as well as the management of any study related side effects up to a total of $4000. This will cover treatment for approximately 4-6 months; after this point in time, if your dog is doing well and continues on therapy, costs for monitoring (bloodwork, x-rays) will not be covered, although the drugs (Palladia/losartan) will be provided at no cost. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the osteosarcoma are your responsibility.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu