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A vaccine therapy for treatment of dogs with osteosarcoma (bone cancer)

Evaluation of a Recombinant, Attenuated Listeria monocytogenes Expressing a Chimeric Human HER2/neu Protein in Dogs with Osteosarcoma in the Adjuvant Setting

Status: Recruiting

Species: Dog

Veterinary Speciality: Oncology

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 Info

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

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