Oncology

Clinical trials for Oncology specialty

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    Description:

    Lymphoma is one of the most common cancers in the dog and is comparable to non-Hodgkin’s lymphoma in humans. Chemotherapy is the standard of care for treatment and can provide long term disease control but survival beyond 2 years is rare.

    There is active investigation into the utility of metabolic markers, such as insulin-like growth factor 1 (IGF-1), as a predictor of response to treatment in humans with non-Hodgkin’s lymphoma. Additionally these markers may serve as a target for future therapy.

    The goal of this study is to assess levels of IGF-1 and other related blood biomarkers in canine patients with lymphoma. We will evaluate these markers for prognostic value and will determine whether they could serve as targets for therapy in the future.

    Inclusion Criteria:

    Dogs with a confirmed diagnosis of multicentric lymphoma (cytology or pathology), weighing more than 25kg. Dogs must be eating a commercial diet and be otherwise healthy.

    Exclusion Criteria:

    Dogs with other systemic diseases (diabetes mellitus, hypothyroidism, Cushing’s disease, kidney disease, liver disease, etc). Dogs eating a home-cooked or raw diet.

    Client Benefits:

    No direct benefits. Dog owners are financially responsible for the costs associated with cancer staging plus standard chemotherapy and recommended treatment monitoring (weekly complete blood counts).

    This study covers the cost of measurement of IGF-1 and other metabolites.

    Contact Information:

    Kelly Reed, Oncology liaison at 508-887-4682 or email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

     

     

     

     

  • Description:

    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 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

  • 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