Vigil + Irinotecan and Temozolomide in Ewing's Sarcoma (VITA)

Cook Children's Hematology and Oncology team is participating in 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 family of tumors. Participants undergoing a standard surgical procedure (e.g., tumor biopsy or palliative resection) may have tumor tissue harvested for manufacture of the investigational product, Vigil.

Who can participate in this trial?

Participants in this trial are children with confirmed Ewing's sarcoma family of tumors, over the age of 2 years, with recurrence or refractory to one line of chemotherapy.

Objectives for the trial

In this study we will compare the overall progression free survival of subjects with relapsed or refractory Ewing's sarcoma dosed with irinotecan and temozolomide vs. Vigil immunotherapy in combination with irinotecan and temozolomide.

How does the trial work?

Surgery for tissue procurement for Vigil manufacture will be scheduled and approved by the patient's oncologist. The patient's tissue procurement will occur during a standard of care biopsy. Once the procured tissue is received by the drug manufacturer, samples will be treated for autologous Vigil manufacture. No tissue or Vigil will be given to the participant or site apart from the outlined clinical protocol and excess tumor tissue, not used for Vigil manufacture will be used towards Vigil research and process development analyses.

Subjects meeting eligibility criteria including manufacture of a minimum of four immunotherapy doses of Vigil will be randomized to receive either:

Group A

oral temozolomide daily + oral irinotecan daily (Days 1-5)
Vigil intradermal on Day 15

Group B

oral temozolomide + oral irinotecan daily (Days 1 – 5)

Improving cancer outcomes through research

As key collaborators with the nation's leading pediatric research organizations, we offer the best available treatments and actively contribute to the search for a cure. Our ultimate goal is to erase kid cancer.

Meet our principal investigator

Anish Ray, M.D., specializes in treating childhood cancer and has a special interest in Langerhans cell histiocytosis (LCH), hemophagocytic lymphohistiocytosis (HLH), as well as other histiocytic disorders, and Ewing's sarcoma family of tumors. He has written a number of publications, posters and presentations. Get to know Dr. Ray.

Questions about Vigil research?

Contact Cook Children's Clinical Coordinator at 682-885-4017.