If you are a parent or legal guardian of a child who has been diagnosed with recurrent osteosarcoma (meaning your bone cancer had come back) and was recently removed by your doctor you may be eligible for this study.
Taking part in this study is voluntary. The treatment involves intravenous infusion of the study drug OST31-164 that is given once every 3 weeks (1 cycle of treatment takes about three months). These treatments are divided into four (12-week treatment) cycles of therapy over 48 weeks altogether. After treatment has been completed, you will have blood drawn and be evaluated for fever or infection every 3 months, for 3 years to monitor for listeria infection (an infection usually caused by eating food contaminated with a bacteria called Listeria monocytogenes (Lm) or bacteria in the bloodstream.
Common side effects are associated with the infusion are described as “flu-like” symptoms and may include chills and/or shivering, anemia (low white blood cell counts), fever, nausea, vomiting, fatigue (feeling tired), headache, and low or high blood pressure. The treatment-related adverse events seen so far have been mainly mild or moderate, mostly occurring on the day of treatment, and usually resolve naturally or easily with standard medical treatment of the symptoms. These common side effects generally lasted less than 4 hours after the infusion was completed. You will be given some medications just before treatment that are intended to reduce the symptoms that may occur during or after the treatment.
You will also be given a prescription from your doctor for antibiotics beginning the day of each treatment and over the next 6 days to prevent complications from OST31-164 treatment.
The following tests will be done because you are part of this study. If you were not in the study, you would probably not have these tests.
Please let us know if you would be interested in joining our mission to identify and clinically prove new treatments for OsteoSarcoma. We are located in the Washington Metropolitan area near the NIH, FDA, researchers, capital and a thriving bio-science culture. Join us!