Full TitleA two-part Phase IIb Trial of Vigil (bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing’s Sarcoma
The purpose of this study is to compare the safety and effectiveness of an investigational immunotherapy with standard chemotherapy in children, adolescents, and adults with metastatic Ewing sarcoma that continues to grow despite prior treatment. The immunotherapy, called the Vigil vaccine, is made from a patient’s cancer cells. The cancer cells are removed from the tumor and two genes are inserted into them: one gene blocks a protein that cancer cells need to grow, and the other makes the immune system more active.
The modified cancer cells are treated with radiation to prevent them from growing again, and then returned to the patient in a monthly injection. The goal is for the vaccine to make cancer cells visible to the immune system, while simultaneously boosting the power of the immune system to kill cancer cells.
Patients in this study will be randomly assigned to receive the Vigil vaccine or the standard chemotherapy (gemcitabine and docetaxel).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic Ewing sarcoma that has continued to grow despite at least two prior regimens of therapy.
- Patients must be planning to have cancer surgery.
- At least 2 weeks must pass since the completion of any prior radiation therapy and 3 weeks since other therapies and entry into the study.
- This study is for patients age 2 years and older.
For more information about this study and to inquire about eligibility, please contact Dr. Leonard H. Wexler at 212-639-7990.