A Phase III Study of Irinotecan and Temozolomide versus Irinotecan, Temozolomide, and Vigil Immunotherapy to Treat Advanced Ewing Sarcoma

Full Title

A Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination with Irinotecan and Temozolimide as a Second-Line Regimen for Ewing’s Sarcoma

Purpose

The purpose of this study is to see if adding an investigational immunotherapy called Vigil to standard chemotherapy (irinotecan and temozolomide) is more effective than standard chemotherapy alone for children and adults with advanced Ewing sarcoma.

Vigil is made from a patient’s own tumor cells that were collected during cancer surgery. After the tumor cells are removed, they are genetically modified in a laboratory so that the patient’s immune system can recognize the tumor cells more easily. Researchers think that using a patient’s own tumor cells to make the Vigil vaccine is the best way to provoke the immune system to respond to the vaccine and fight the cancer.

Patients in this study will be randomly assigned to receive just irinotecan and temozolomide OR irinotecan, temozolomide, and Vigil. Irinotecan and temozolomide are taken orally (by mouth) and Vigil is given by injection under the skin.

Eligibility

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 came back or continues to grow despite prior treatment.
  • This study is for patients age 2 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Leonard Wexler at 212-639-7990.

Protocol

18-466

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators