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.

The overall goal of this study is to determine whether OST31-164 will prevent or delay your osteosarcoma from coming back again.

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.

It is important that you take the antibiotics after treatment and come in every 3 months for 3 years for a blood culture just to make sure that there is no Lm in your bloodstream.

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.

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.

  • If you are currently receiving antibiotics you must stop using them
  • Frequent lab tests to monitor your blood counts and blood chemistries.
  • Pregnancy tests for females of childbearing age
  • An echocardiogram or radionuclide angiogram
  • Disease imaging will occur (MRI, CT or X-ray of the primary tumor site) to assess disease control
  • Lab tests will be taken at 3 weeks and every 3 months after your last dose of OST31-164 for a total of 3 years to check to see if there is any Lm left in your blood.
We would also like to do some biologic studies to learn more about the effects of OST31-164 on the cells in your immune system. This will require us to take some blood samples and send them out for analysis. These tests are important to help us learn more about OST31-164 and may help people who have been diagnosed with osteosarcoma in the future.

We would like to take some of your tumor tissue which has already been removed and may be stored at the hospital laboratory and send it to the Children’s Oncology Group’s laboratories for future research. There, your tumor sample will be added to a large group of similar osteosarcomas to learn as much as we can about the osteosarcomas utilizing state of the art analysis now and in the future. We hope that what is learned can help identify new and more effective treatments and preventions for others with osteosarcoma.

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