Flint Animal Cancer Center

Evaluation of Listeria monocytogenes expressing a chimeric human HER2/neu protein in dogs with osteosarcoma

Patient Disease:

Canine Osteosarcoma

Study Name:

COTC026: Evaluation of a recombinant, attenuated Listeria monocytogenes expressing a chimeric human HER2/neu protein in dogs with osteosarcoma in the adjuvant setting

Purposes of the study:

  • To investigate the effectiveness of a Listeria vaccine (ADXS31-164) in delaying or preventing metastatic disease in dogs with osteosarcoma treated with standard of care chemotherapy

  • Evaluate the effects of the vaccine in the setting of established metastatic disease from osteosarcoma

 Primary Eligibility Criteria:

  • Cytologic or histopathologic confirmation of osteosarcoma diagnosis of a limb

  • No evidence of metastatic disease

  • Healthy otherwise

  • No prior treatment for osteosarcoma

  • Weight > 25 kg (55 lb)

 Study Protocol:

  • Determine eligibility with initial screening: physical exam, blood tests (CBC, biochemistry, urinalysis), confirmation of osteosarcoma diagnosis, chest x-rays and abdominal ultrasound to confirm there are no metastases

  • Surgery - amputation of affected limb

  • Approximately 2 weeks after surgery - start carboplatin chemotherapy given every 3 weeks for 4 doses

  • Week 15 start vaccine therapy – given every 3 weeks for 3 treatments

  • If evidence of metastatic disease is found during carboplatin treatment, dogs are eligible to start vaccine therapy at that time

 Owner Responsibilities:

  • To make and keep all study related appointments

  • To have limb amputation surgery performed at CSU

 Financial Incentives:

  • Study covers costs of all exam fees and chest x-rays throughout study

  • Study pays for all costs related to vaccine administration as well as up to $500 towards treatment of side effects related to vaccine

If you have further questions about any of our clinical trials, please submit an online consulting form. Your consult will then be directed to an appropriate oncology clinician. Requests are typically returned within 5 business days.