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Clinical Trial: Using a Recombinant Bacteria Vaccine


Clinical Trial: Evaluation of a recombinant bacteria vaccine to treat bone cancer in dogs
Purpose

Status: Closed

The purpose of this study was to determine whether a recombinant L. moncytogenes vaccine can elicit anti-tumor immunity and prolong survival in dogs with cancer of their long bones (appendicular osteosarcoma (OSA)).

Sponsor: Advaxis, Inc.

Enrollment criteria and baseline evaluation of patients

This pilot study was initiated to determine the safety and efficiacy Dr. Mason's osteosarcoma study, Penn Vetof a new bacteria based vaccine to stimulate an immune response against osteosarcoma and prolong survival in dogs with bone cancer.

Only those dogs with a histological diagnosis of osteosarcoma and who have undergone limb amputation and standard chemotherapy (4 doses of carboplatin) for the treatment of osteosarcoma were eligible for inclusion in the study.

In addition, only those patients whose tumors expressed the target antigen “Her-2/neu” were eligible for inclusion in this study.

Eighteen privately owned dogs with long bone cancer (appendicular OSA) and confirmed expression of Her2-neu were enrolled. At enrollment (3 weeks following the last dose of carboplatin chemotherapy), all eligible dogs received basic clinical laboratory tests including a Complete Blood Count (CBC), Chemistry Screen (CS) and urinalysis (UA) and a baseline evaluation of cardiac function by echocardiography and measurement of cardiac-specific Troponin I (cTnI) levels. Thoracic radiographs were taken to determine whether pulmonary metastases are present. At the time of enrollment, a blood sample was taken to assess immune function and baseline levels of anti-tumor immunity.

L.m recombinant treatment

All dogs were vaccinated, with no placebo control. The first vaccine was given three weeks after the last dose of routine chemotherapy. Patients received a total of 3 vaccines given three weeks apart. Patients stayed in the hospital for 48 hours following vaccine administration for observation.

Contact Us

If you are interested in learning more about this study, please contact the Prinicipal Investigator Dr. Nicola Mason at 215 898 3996 or nmason@vet.upenn.edu