Oncology

Clinical trials for Oncology specialty

  • Status:  Enrollment closed

    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

     

  •  

    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: Enrolling

    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: #G2016-156

    Status: Currently enrolling

    Description:

    Resistance to chemotherapy is a major obstacle in the treatment of cancer. Research has uncovered many ways by which cancer cells are able to avoid being killed by chemotherapy. STAT3 is a protein that is often activated in tumors and acts to protect tumor cells from the effects of chemotherapy. STAT3 also promotes tumor spread (metastasis) to other parts of the body such as lungs and liver. Because of its central role in helping promote tumor growth, there are numerous efforts focused on blocking the effects of STAT3 to see if this can enhance the effects of chemotherapy treatment and prevent tumor spread. Oclacitinib (Apoquel) is an FDA approved drug designed to treat canine atopic dermatitis, an allergic disease of the skin.  It works by blocking two proteins, JAK1 and JAK3 that contribute to STAT3 activation; oclacitinib has been shown to block STAT3 activation in normal and tumor cells in the research laboratory.  Preliminary data indicated that combining oclacitinib with chemotherapy may enhance the effects of chemotherapy treatment.  Therefore, the purpose of this study is to determine whether the combination of carboplatin or doxorubicin (both commonly used chemotherapy agents) and oclacitinib is clinically safe and well tolerated in dogs with cancer. A secondary aim of the study is to determine if the combination of carboplatin or doxorubicin and oclacitinib will reduce tumor size in dogs with carcinoma, sarcoma or melanoma.

     Inclusion Criteria:

    • Dogs diagnosed with carcinoma, sarcoma, or melanoma 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.
    • 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 oclacitinib according to designated schedule.

    Exclusion Criteria:

    • Pregnant or lactating dogs
    • Dogs with uncontrolled autoimmune disease are not eligible.
    • 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).
    • Use of any other investigational drug within 1 week of study entry.

    Client Benefits:

    The study will cover all of the costs of screening if your dog is found to be eligible, two doses of chemotherapy and 42 days of oclacitinib. The study will also cover the costs of weekly examination and laboratory tests. Your dog’s participation will also allow us to gain information that will help in the treatment of other dogs diagnosed with cancer. While your dog may benefit from this study, it is possible that the combination of both drugs has no benefit.

    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: Enrolling

    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