Gradalis CL-PTL-130

Official 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 Temozolomide as a Second-Line Regimen for Ewing’s Sarcoma

Study Purpose

To test the safety and efficacy of Vigil is when given with standard chemotherapy. To determine if Vigil given with standard chemotherapy prevents or delays tumor growth or shrinks an existing tumor.

Diagnosis

Eligibility

Planned standard of care surgical procedure, e.g. tumor biopsy or thoracentesis of soft tissue mass and/or pleural fluid.

To take part in the randomization process and participate in the main study, at least 4 vials of Vigil must be manufactured.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

A part of the cancer tissue is used to try to make the bi-shRBA and GMCSF Augmented Autologous Tumor cell immunotherapy also known as Vigil. If the Vigil preparation is successful, taking part in the main study may be approved. This would consist of being randomized into one of the two groups described below:

• Group A: Vigil and standard chemotherapy (Irinotecan and Temozolomide)
• Group B: Standard chemotherapy (Irinotecan and Temozolomide)

After study completion and if the cancer worsens, eligibility to receive Vigil may be possible.