Oncology

Clinical trials for Oncology specialty

  • 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            

  • IACUC Protocol: # G2017-80

    Status: Currently 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

     

     

     

     

  • Status: Currently enrolling

    Description:

    This clinical trial led by the National Cancer Institute (NCI) and sponsored by the Morris Animal Foundation evaluates the safety and effectiveness of ADXS31-164c when given to dogs with osteosarcoma after receiving standard of care treatment. Standard of Care is defined as definitive surgery, defined as amputation of the affected limb, followed by 4 doses of intravenous carboplatin chemotherapy given on an every 21 day schedule. Carboplatin has been safely and effectively used to treat appendicular osteosarcoma in dogs for more than 20 years, but the potential for unforeseen potentially life-threatening side effects from surgery, chemotherapy, and/or progressive cancer does exist.

    Bone cancer or osteosarcoma (OSA) is a common, highly aggressive cancer that frequently affects the long bones of large breed dogs. Current therapy consists of limb amputation plus chemotherapy. However, despite therapy, most patients die as a result of the cancer spreading to other parts of their bodies. The immune system plays an important role in identifying and targeting cancer cells in the body. In this study, we aim to use a new approach to stimulate the body’s own immune system to attack remaining tumor cells in dogs that have undergone limb amputation and chemotherapy for the treatment of OSA. We will use a vaccine made from the bacteria Listeria monocytogenes, which has been genetically modified to express a tumor protein (HER-2/neu) that is found in many cancer cells, including canine bone cancer cells and cancer stem cells. When injected into the bloodstream, the modified Listeria stimulates the immune system to attack cells expressing the HER-2/neu tumor protein. This approach aims to delay and/or prevent the spread of cancer (metastases) following removal of the primary bone cancer tumor (limb amputation) and chemotherapy.

    Inclusion Criteria:

    • Histologically or cytologically (consistent with a mesenchymal neoplasm) confirmed appendicular osteosarcoma, which includes all long bones of the limbs (radius, humerus, ulna, scapula, femur and tibia), but excludes metatarsus, metacarpus, carpal and tarsal bones, and digits.
    • Measurable disease that is amenable to surgical removal via amputation (No evidence of metastasis based upon physical exam, thoracic radiographs, and abdominal ultrasound).
    • Favorable performance status: Grade 0 or 1 (modified ECOG criteria)
    • ONLY newly diagnosed dogs are eligible with no prior therapy (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates) for osteosarcoma
    • Informed owner consent for trial
    • Dogs must undergo full post-mortem examination (necropsy) if they die while on study

    Exclusion Criteria:

    • Dogs < 25 kg in size post amputation
    • Dogs without measurable disease (appendicular osteosarcoma) at presentation to Tufts
    • ANY prior therapy for osteosarcoma (conventional or metronomic chemotherapy, ionizing radiation, bisphosphonates)
    • Concurrent medications deemed incongruent with this study. All pre-existing necessary medications should be recorded as concomitant medications.
    • Significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure or clinical coagulopathy
    • Creatinine > 2.0 mg/dL
    • Bilirubin > 2.0 mg/dL or elevated bile acids
    • HCT < 25%, platelets < 100,000 cells/ul
    • UP:C> 2.5
    • Any hematologic/biochemical (excluding ALT or ALP-detailed below) abnormalities > grade 1 (VCOG-CTCAE).
    • Dog will be eligible as long as liver ALT is equal or less than 2.5x normal reference range IF patient has been managed with NSAID therapy at the time of presentation. If no current usage of NSAIDs, eligibility will remain the defined 1.5x normal reference range.
    • Total ALP elevations less than 5-fold increased upper reference range, in the concurrent absence of significant ALT elevations (Grade I (1.5xULN) or less), will be acceptable for inclusion into study.

    Client Benefits:

    Some but not all costs associated with this study will be provided as part of your participation. The study will cover the appointment fee on the days when carboplatin chemotherapy is administered as well as for chest x-rays performed prior to the third and after the fourth dose of carboplatin.  The costs associated with amputation and carboplatin chemotherapy (drug, administration fees, laboratory tests, and ancillary medications) remain the responsibility of the pet owner who has signed below.  The study will cover the cost of appointment fee, vaccine and administration, antibiotics and monitoring tests for each of the three vaccinations.  In the event, any complications arise from ADXS31-164c administration, their management will be covered by study funds up to $500/per dog.  This would include any unanticipated hospitalizations. Please discuss the treatment and study costs with your clinician.

    Contact Information:

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

  • Protocol #G2018-31

    Status: Currently enrolling

    Inclusion Criteria: Dogs with histopathologically diagnosed Stage II splenic hemangiosarcoma (HSA) following splenectomy with no evidence of disease at the time of enrollment based on thoracic radiographs and abdominal ultrasound, and intention to treat with 5 cycles of a doxorubicin-based chemotherapy protocol. 

    Exclusion Criteria: Dogs that have received therapies known to affect coagulation, including Vitamin K, blood products, non-steroidal anti-inflammatories, clopidogrel, heparin, rivaroxaban, epixaban, Yunnan Baiyao, or hydroxylethyl starch within 7 days of enrollment. Greyhound dogs and patients with confirmed diseases that affect coagulation, including immune-mediated disease, protein-losing nephropathy, protein-losing enteropathy, and hyperadrenocorticism will also be excluded. 

    Data Collection: Measurement of coagulation profiles will coincide with a routine re-staging schedule during a doxorubicin chemotherapy protocol; prior to initiation of chemotherapy, at the time of the third and fifth doxorubicin treatments, and monthly thereafter until recognition of metastatic disease. A complete blood count and t-PA TEG will be run at each of the aforementioned timepoints; samples for PT/PTT, fibrinogen, and D-dimers will be frozen for batch analysis. If metastatic disease is detected at any intermediate timepoint, a final coagulation sample will be collected. 

    Benefit: All coagulation testing (t-PA TEG, PT/PTT, fibrinogen, and D-dimers) will be covered by the study. Owners will be expected to pay for the complete blood count, as it is part of the standard chemotherapy protocol.

    Contact information:

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

  • IACUC Protocol # G2018-22

    Status: Enrolling

    Description:

    The purpose of this clinical trial is to evaluate the activity of new formulation of an old chemotherapy drug called paclitaxel in dogs with mast cell tumors.  Paclitaxel is not water soluble and therefore needs to be formulated with a chemical that permits intravenous administration.  ART207 is a new formulation of paclitaxel in which the drug is encapsulated in a lipid (fat) protein complex designed to promote specific uptake of the complexes through cholesterol receptors that are expressed in tumors.  ART207 results in much higher exposures to paclitaxel than the previous formulations and may have greater anti-tumor activity in dogs with cancer.

    The ultimate goal of this clinical trial is to shrink your dog’s tumor by using a novel formulation of paclitaxel that selectively targets the tumor cells, thereby reducing systemic side effects. As paclitaxel is known to have activity against tumors in dogs, it is likely that ART207 will have equivalent or superior activity to paclitaxel given its higher drug exposures.

    Inclusion Criteria:

    • Dogs must have a cytologic or histopathologic diagnosis of mast cell tumor. 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 have measurable tumor at least 2 cm in size or greater
    • Dogs must be greater than 1 year of age
    • Dogs must weigh at least 5 kg
    • Dogs must have adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
    • Dogs must be 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
    • Dogs must be able to return for study visits as dictated by the study calendar

    Exclusion Criteria:

    • Pregnant or lactating dogs
    • Any abnormality on the CBC or chemistry panel deemed to be significant by the principle investigator
    • 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 liver, cardiac and/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.
    • Dogs with evidence of systemic mast cell disease (i.e., spread to the liver, spleen, bone marrow, etc).

    Client Benefits:

    The study will cover all diagnostics (bloodwork, imaging, biopsies, etc) and treatments (ART207 administration, supportive medications) associated with the tumor while your dog is enrolled in this study as well as the management of any study related side effects. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the mast cell tumor are your responsibility.

    Contact information:

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

     

     

     

  • IACUC # G2017.129

    Status: Enrolling

    Description:

    The purpose of this clinical trial is to evaluate the activity of new immunotherapy agents for the treatment of osteosarcoma that has spread to the lungs.  The ultimate goal is to find drug combinations that either stop the growth of tumor spread or that actually shrink the spread by stimulating the immune system to control the cancer.

    Your dog will undergo several blood tests/diagnostics prior to and during the course of treatment to monitor blood counts and collect plasma/blood for additional genetic analyses. These blood draws amount to approximately 2 tbsp. of blood at each visit. Your dog’s treatment for osteosarcoma will involve the administration of two drugs orally at home to help control the cancer: toceranib (Palladia) and losartan. Palladia received FDA approval to treat mast cell tumors in dogs in 2009. Since then it has been used to treat several types of cancer in dogs. Losartan is a generic version of a drug called Cozaar which is used to treat high blood pressure in people. Both drugs have been tested extensively in dogs with cancer either alone or in combination to ensure that the dose being given is safe.

    Inclusion Criteria:

    - At least one year old on Day 0 and weigh at least 10 kg (22 lbs)

    - All dogs must have had surgical resection of the primary tumor with a histologically confirmed diagnosis of OSA.

    - All dogs must have measurable pulmonary metastatic disease, documented by thoracic radiographs.

    - Prior chemotherapy (or other specific therapy for OSA) or any other anti-cancer therapy is acceptable with a 2-week washout from prior treatment.

    - Dogs must have adequate organ function as indicated by standard laboratory tests: (hematology (CBC), clinical chemistry and urinalysis).

    - The animal must have a performance status of either 0 or 1 on Day 0, according to the modified ECOG Performance Scheme.

    - The Owner must have provided written, informed consent prior to enrolling in the study.

    Exclusion Criteria:

    - Dogs that have received chemotherapy within 2 weeks of Day 0.

    - Concurrent malignancy, or other serious systemic disorder incompatible with this study.

    - Dogs that are on homeopathic/alternative therapies for OS. These treatments should be discontinued on Day -1. Supplements such as chondroitin sulphate, vitamins, essential fatty acids and glucosamine are permitted during the trial period. Pain medications such as opioids and NSAIDs are permitted at the discretion of the clinician, provided they were also administered prior to the development of metastases

    Client Benefits:

    The study will cover all diagnostics (bloodwork, x-rays, etc) and treatments (oral drugs) associated with the osteosarcoma while your dog is enrolled in this study as well as the management of any study related side effects up to a total of $4000. This will cover treatment for approximately 4-6 months; after this point in time, if your dog is doing well and continues on therapy, costs for monitoring (bloodwork, x-rays) will not be covered, although the drugs (Palladia/losartan) will be provided at no cost. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the osteosarcoma are your responsibility.

    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:

    The purpose of this clinical trial is to evaluate the activity of two drugs when given in combination to treat a type of cancer called soft tissue sarcoma. This tumor type is very resistant to chemotherapy and radiation, and in the setting of bulky disease, less than 10-20% of tumors will experience shrinkage.  Doxorubicin (DOX) is the most common chemotherapy agent used to treat sarcomas in both dogs and people, however it is relatively ineffective in most cases.  We have recently completed a clinical trial testing the effectiveness of combining DOX with a new oral drug (KPT-9274) in dogs with a cancer termed lymphoma.  The KPT-9274 works by blocking key proteins in cancer cells, and we found that the two drugs, when given together, were very well tolerated (no increase in side effects over DOX alone) and significantly increased response of the lymphoma to the DOX.  Based on these results, it is possible that the DOX/9274 combination may work more effectively in other cancers as well.  Therefore, the purpose of this trial is to combine DOX/9274 for a total of 4 treatments (once every 3 weeks x 4 treatments) in dogs with sarcomas.

    Inclusion Criteria:

    • 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 be at least 1 year of age
    • Dogs that have received any prior therapy must have occurred at least 14 days prior to enrollment
    • Informed written consent obtained

     

    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)

    Client Benefits:

    The ultimate goal of this clinical trial is to shrink your dog’s tumor by combining the DOX and KPT-9274. In some cases, if a tumor is growing rapidly, treatments that stop growth without actually shrinking the tumor can provide significant benefit.

    The study will cover all diagnostics (bloodwork, imaging, etc) and treatments (DOX/9274 administration, supportive medications) associated with the sarcoma while your dog is enrolled in this study as well as the management of any study related side effects. Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the sarcoma are your responsibility.

    Contact Information:

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