Clinical trials for Oncology specialty

  • 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
    • VCA Animal Specialty Center, Yonkers, NY
    • The Veterinary Cancer Center, Norwalk, CT
    • VCA South Paws Veterinary Specialists and Emergency Center, Fairfax, VA


    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.

    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Client Benefits:

    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.

    Contact Information:

    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:   clinicaltrials@tufts.edu

  • Purpose of Study”: The cancer that most commonly affects the mouth of cats is called oral squamous cell carcinoma (OSCC).  This cancer is common and responds poorly to treatment.  The average life-expectancy for cats diagnosed with this cancer is about 6 months with only 10-20% of cats alive 1 year after diagnosis.  Cats may exhibit a number of problems as a result of OSCC including a swelling in the head/throat, lack of appetite, difficulty eating or swallowing, decreased grooming behavior, excessive salivation, foul odor to breath, change in voice or difficulty in vocalizing. The purpose of this study is to determine if a drug called “Anginex” would provide a safe and effective means of treating OSCC in cats. Anginex is a peptide (small protein) that interferes with the ability of a tumor to make and maintain its blood supply, a process known as angiogenesis.  Cancer drugs that target the blood supply of a tumor are called “anti-angiogenic “or “anti-vascular” agents.  Because tumors need a blood supply to grow beyond microscopic size, inhibiting angiogenesis prevents tumors from growing and can cause tumors to shrink.  Anginex has been used in mice experimentally.  In this current study, our goals are to ensure that this agent is safe for cats and also to determine whether it has any effects on the tumor and its blood vessels and oxygen levels.

    Inclusion Criteria:

    1.  Cats with a diagnosis of OSCC.
    2. Cats that have not received radiation or chemotherapy (including Palladia) for treatment of the cancer.
    3. The tumor has not been surgically removed.
    4. The tumor is measurable and accessible.

    Exclusion Criteria:

    1. Cats with other systemic diseases that are uncontrolled and likely to compromise the ability of the cat to complete treatment.
    2. Tumors that are not readily accessible to biopsy and other procedures.

    Client Benefits: The study will cover the costs of certain diagnostic tests and treatment.  These include: biopsy and pathologist evaluation of tissue, blood and urine evaluation, advanced imaging with PET/MRI and CT, which can aide in future treatments of the tumor such as surgery or radiation therapy. The study will not cover the cost of the initial consultation with the oncology service.

    Contact Information: To make an appointment with the oncology department please call the oncology liason, Kelly Reed at 508-887-4682 For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • 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.

    Inclusion Criteria

    1. 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.
    2. All dogs must be treated with definitive intent radiotherapy, defined as dose ≥45 Gy or higher.
    3. Prior surgery or chemotherapy is acceptable with a 2-week washout.
    4. Prior glucocorticoid therapy is allowed if the patient has been on this therapy for a minimum of 2 weeks prior to Day 0.
    5. Prior antibiotic therapy is acceptable within a 1-week washout from the start of radiotherapy.
    1. 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.
    2. Any homeopathic/alternative therapies for cancer must be discontinued prior to enrollment.

    Exclusion Criteria

    1. Tumors located in the oral or nasal cavities, on the muzzle, or in the perineal region.
    2. Dogs that had a surgical flap procedure at the radiation site.
    3. Dogs that experienced a post-operative surgical infection.
    4. Dogs that require concurrent chemotherapy.
    5. Dogs that have received prior radiation therapy to the tumor site.
    6. Dogs that are currently on antibiotic therapy.
    7. Dogs with pre-existing dermatopathies.


    Client Benefits

    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

  • Description:         

    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.

    Inclusion Criteria:

    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.

    Exclusion Criteria:

    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.

    Client Benefits:

    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.

    Contact Information:

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


  • Description:

    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.

    Inclusion Criteria:

    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

    Exclusion Criteria:

    Any systemic disease that might predispose increase risk with regards to the biopsy procedure (i.e., heart murmur, renal disease, brachycephalic breed).

    Client Benefits:

    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.

    Contact Information:

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

  • Description:

    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).

    Inclusion/Exclusion Criteria:                                             

    Normal Lymph nodes:

    Inclusion –

    1. Dogs that are euthanized at the FHSA and the body is available for donation or necropsy.

    Exclusion –

    1. Dogs with metastatic cancer, systemic infectious or inflammatory disease will be excluded.


    Inclusion –

    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

    Client Benefits:

    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.

    Contact Information:

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


  • Description:

    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

    Inclusion Criteria:

    Canine patients presenting the Foster Hospital of Small Animals who will be prescribed toceranib at a target dose.

    Exclusion Criteria:

    • 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
    • Hypoadrenocorticism.

    Client Benefits:

    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.

    Contact Information:

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