A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma
Completed · Phase 2
Conditions studied: Ewing's Sarcoma
In brief
A two-part trial in patients with metastic Ewing's sarcoma. Participants in Part 1 will be randomized to receive either Vigil immunotherapy or gemcitabine and docetaxel with the objective of comparing the overall survival between the two arms. Participants enrolled in Part 2 will receive Vigil immunotherapy in combination of temozolomide and irinotecan with the objective to determine the safety profile of the combination treatment.
Key facts
- Study ID
- NCT02511132
- Run by
- Gradalis, Inc.
- People needed
- 22
- Starts
- 2016-02-10
- Expected to finish
- 2020-12-23
- Last updated by the study team
- 2022-12-22
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Nicklaus Children's Hospital (Miami Children's Health System) — Miami, Florida, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Cleveland Clinic Children's — Cleveland, Ohio, United States
- Mary Crowley Cancer Research Centers — Dallas, Texas, United States
- TOPA - Medical City Dallas Pediatric Hematology-Oncology — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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