Mason Bone Cancer Study
Bone Cancer StudyEvaluation of a recombinant bacteria vaccine to treat bone cancer in dogs
The purpose of this study is 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)).
Enrollment criteria and baseline evaluation of patients
We are actively recruting patients for a pilot study to determine the safety and efficiacy of 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 will be eligible for inclusion in the study. In addition, only those patients whose tumors express the target antigen “Her-2/neu” will be eligible for inclusion in this study.
Up to 18 privately owned dogs with long bone cancer (appendicular OSA) and confirmed expression of Her2-neu will be enrolled. At enrollment (3 weeks following the last dose of carboplatin chemotherapy), all eligible dogs will receive 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 will be taken to determine whether pulmonary metastases are present. At the time of enrollment, a blood sample will be taken to assess immune function and baseline levels of anti-tumor immunity.
L.m recombinant treatment
All dogs will be vaccinated, there is no placebo control. The first vaccine will be given three weeks after the last dose of routine chemotherapy. Patients will receive a total of 3 vaccines given three weeks apart. Patients will stay in the hospital for 48 hours following vaccine administration for observation.
The study pays for the following:
- Complete staging of disease at the time of enrollment (includes CBC, CS, UA, immune function assessment, thoracic radiographs, cardiac evaluation)
- Three vaccines
- Hospitalization for observation
- CBC, CS, UA and cardiac evaluation every three weeks for a total of 9 weeks
- Routine staging every 2 months following last vaccine administration (includes CBC, CS, UA, immune assessment, thoracic radiographs, cardiac evaluation)
If you are interested in learning more about this study, please contact the Prinicipal Investigator Dr. Nicola Mason at 215 898 3996 or [email protected]