Oncology

Clinical trials for Oncology specialty

  • Enrollment currently on Hold

    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:

    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.

    Lymphoma:

    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

  • Description:

    The purpose of the study is to determine the safety and efficacy of a novel anti-cancer agent, BKM120 in dogs with non-Hodgkin’s lymphoma. This drug is unique in that it targets a particular pathway that is often abnormal in many types of cancer, including lymphoma. BMK120 has been shown to have efficacy in treating numerous human cancers with an acceptable safety profile.

    If you decide to participate in this study, your dog will be treated by a group of veterinarians specializing in clinical cancer research. Blood specimens and biopsy samples are an integral part of the treatment program and will be done at intervals at the recommendation of the veterinarian in charge and in accordance with the study protocol. As part of a cancer clinical trial, it is important to obtain information about the effectiveness of the drug therapy given to your dog.

    Inclusion Criteria:

    1. Species: Canine / various pure and mixed breeds
    2. Sex: male and female, intact and neutered
    3. Age Range: at least one year old on day 0
    4. Weight Range: greater than 10 kg on day 0
    5. Dogs diagnosed with histologically or cytological confirmed B or T cell lymphoma leukemia are eligible to be enrolled. The patient may have failed standard therapy or there may be no other known effective antineoplastic therapeutic options, or the owner may elect to enter the patient in lieu of standard therapy (e.g. Dogs will offered participation in this trial if they failed conventional therapy or if the owner is unable or not interested in pursuing conventional therapy).
    6. All dogs must have a histologic or cytologic diagnosis of lymphoma confirmed. Documentation through immunohistochemistry, immunocytochemistry or flow cytometry, or monoclonal immunoglobulin gene rearrangement by PCR for antigen receptor rearrangement must be performed. These tests are routine/standard of care, but immunophenotyping is not always completed since it is not necessary for treatment. If immunophenotyping has not been previously completed, then the investigators may provide funds for the necessary testing.

    Exclusion Criteria:

    1. Dogs with confirmed diabetes.
    2. Dogs that have received chemotherapy within 1 week of Day 0.
    3. Dogs that have received radiation therapy within 3 weeks of Day 0.
    4. Use of any other investigational drug within 1 week of study entry.
    5. Concurrent malignancy, other than NHL, or other serious systemic disorder incompatible with this study.
    6. Dogs receiving homeopathic/alternative therapies for their NHL – unless these therapies are discontinued on or prior to Day -1. Supplements such as chondroitin sulphate, vitamins, essential fatty acids and glucosamine are permitted during the trial period.
    7. 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.

    Client Benefits:

     The study will cover all of the costs associated with your participation in the clinical trial including examination fees, blood work, biopsy fees, anesthesia, immunophenotyping (if indicated) and cost of study drug. Your pet’s participation will allow us to gain information, which will help in the treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

     Contact Information:

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

  • Description:

    This clinical trial led by the National Cancer Institute (NCI) and sponsored by the Morris Animal Foundation seeks to evaluate in dogs with osteosarcoma the safety and effectiveness of Standard of Care therapy, with or without adjuvant rapamycin administration. Standard of Care is defined as definitive surgery, being amputation of the affected limb, followed by 4 doses of intravenous carboplatin chemotherapy given on a q21 day schedule. Carboplatin has been safely and effectively used to treat appendicular osteosarcoma in dogs for > 20 years, but the potential for unforeseen potentially life-threatening side effects from surgery, chemotherapy, and/or progressive cancer does exist. ALL dogs enrolled onto study will receive Standard of Care therapy; however, through a randomization process, some dogs entered into study will also receive additional therapy with oral rapamycin.

    Rapamycin is a drug currently approved for immunosuppression during preparatory and maintenance regimens for organ and bone marrow transplant in human patients. Early work with rapamycin suggests that this agent might also have anti-cancer properties by inhibiting (reducing the effects of) an important pathway in cancer progression known as mTOR. Preclinical studies of rapamycin in mice, as well as recent data using analogous drugs in human patients (rapalogs), suggest that mTOR blockade might be effective in the treatment of several cancers. In a recently completed study of rapamycin in dogs with cancer, a dose and schedule for rapamycin administration have been defined which appears to be safe and tolerable by most dogs.

    Within this study, dogs will undergo surgical amputation of the affected limb. Dogs will return to Cummings Veterinary Medical Center every 3 weeks for 15 weeks for evaluation. On weeks 3, 6, 9 and 12, dogs will receive treatment carboplatin chemotherapy. After 15 weeks of Standard of Care, based upon initial study randomization, dogs will either receive oral rapamycin on a 4 day on/3 day off schedule for 4 months or will not be treated with any additional medications and simply be monitored every 8 weeks.

    Eligibility Criteria:          

    1. Histologically or cytologically (inclusive of alkaline phosphatase positivity) confirmed osteosarcoma
    2. Measurable disease that is amenable to surgical removal via amputation (No evidence of metastasis based upon physical exam, chest x-rays, and abdominal ultrasound).
    3. Favorable performance status: Grade 0 or 1 (modified ECOG [Eastern Cooperative Oncology Group] criteria) – Briefly, Grade 0 means that the animal’s activity level is completely normal; Grade 1 allows for mild lethargy but the animal is still able to perform all “activities of daily living.”
    4. ONLY newly diagnosed dogs are eligible with no prior therapy (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates) for osteosarcoma
    5. Dogs receiving analgesics including NSAIDs, gabapentin, tramadol, or other will be eligible for study inclusion
    6. Informed owner consent for trial (approved by CSRC/IACUC) – Client’s informed consent includes permission for dogs to undergo full post-mortem examination (necropsy) if the dog dies while on study

    Exclusion Criteria:

    1. Weight < 25 kg (55 pounds)
    2. Dogs without measurable disease (appendicular osteosarcoma) at presentation to Tufts
    3. ANY prior therapy for osteosarcoma (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates)
    4. Concurrent medications deemed incongruent with this study; to be determined by NCI COTC investigators.
    5. Significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure or clinical coagulopathy
    6. Creatinine > 3.0 mg/dL
    7. Bilirubin > 2.0 mg/dL or elevated bile acids
    8. HCT < 25%, platelets < 150,000 cells/ul
    9. Any hematologic/biochemical abnormality > grade 1 ( According to the Veterinary Cooperative Oncology Group – Common Terminology Criteria for Adverse Events [VCOG-CTCAE] v1.1 – which appears in Appendix II in the COTC protocol)

    Client Benefits 

    Costs associated with this study (including carboplatin and rapamycin administration and study-related evaluations will be covered by the study. In addition, $1,000 will be provided towards the cost of surgical amputation

    Contact Information:

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