Oncology

Clinical trials for Oncology specialty

  • Status:  Currently enrolling

    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

     

  • Status: Currently enrolling

    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

  • Status: Fully enrolled

    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

  • Status:  Currently enrolling

    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

     

     

  • 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 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