Clinical Trial: Evaluation of a recombinant bacteria vaccine to treat bone cancer in dogs
Status: Enrollment is closed. Please note that Phase I of this clinical trial is now closed and no longer enrolling patients.
Purpose: The purpose of this study is to determine whether a recombinant L. Dr. Mason bone cancer studymoncytogenes 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 recruiting patients for a pilot study to determine the safety and efficacy 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.
What the study pays for
- If you are interested in learning more about this study, please contact the Prinicipal Investigator:
- Dr. Nicola Mason, PhD
- Phone: 215-898-3996
- Dr. Nicola Mason, an Assistant Professor of Medicine in collaboration with Advaxis Inc. is currently evaluating the first vaccine for canine osteosarcoma. This approach harnesses the power of the dog’s immune system, “training” it to seek out and destroy cancer cells that remain after amputation and Sashachemotherapy. In a phase I clinical trial, dogs are being recruited to determine the safety and efficacy of a genetically modified Listeria vaccine to prolong survival.
Sasha was diagnosed with osteosarcoma, a highly aggressive bone cancer in March of 2012. The prognosis for this disease is guarded at best and dogs that undergo amputation followed by chemotherapy, the standard of care for this disease, have a median survival of only 1 year. Most dogs die as a result of cancer metastases (spread) to their lungs or other bones. Sasha finally succumbed to this disease in March 2014, adding another year to her life than expected.
Sasha was the first of six dogs that have received the experimental vaccine so far. All dogs tolerated the vaccine well with no significant short or long-term side effects.
“Although it is too early yet to determine whether the vaccine prolongs overall survival in patients with this highly aggressive disease, we can conclude that the vaccine appears to be safe and well tolerated. This is a very important first step,” Mason says. “Given the safety of the vaccine at the current doses used, we are extending the study and continuing to enroll patients.”
- Sasha was the first dog to receive this cancer vaccine. You can read about Sasha on a blog written by her owners Carlos and Liliana Ruano.
- Read Sasha's story...
- Learn more about Advaxis Inc.