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NCT02511132 · ClinicalTrials.gov registry record · Phase 2
A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma
A Phase 2 study of Ewing's Sarcoma, sponsored by Gradalis.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 6
- Study locations
NCT02511132: Completed Phase 2 study of Ewing's Sarcoma, sponsored by Gradalis.
NCT02511132 is a Phase 2 study of Ewing's Sarcoma that has completed, run by Gradalis. The registered enrollment target is 22 participants, below the 83-participant average among 7 other Ewing's Sarcoma trials with a reported enrollment target (73% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02511132, a Phase 2 study of Ewing's Sarcoma, has completed, sponsored by Gradalis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
To determine safety profile of Vigil immunotherapy in combination with irinotecan and temozolomide with 30 days of last dose in patients with metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy. • To determine safety profile of Vigil immunotherapy in combination with irinotecan and temozolimidetemozolomide in patients with metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Temozolomide
- DRUG Gemcitabine
- DRUG Irinotecan
- BIOLOGICAL Vigil
Study Locations (6)
Texas
- Mary Crowley Cancer Research Centers - Dallas
- TOPA - Medical City Dallas Pediatric Hematology-Oncology - Dallas
Arkansas
- Arkansas Children's Hospital - Little Rock
Florida
- Nicklaus Children's Hospital (Miami Children's Health System) - Miami
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cleveland Clinic Children's - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-02-10 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 2 |
What the finished NCT02511132 record still lists
NCT02511132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 83-participant average among 7 other Ewing's Sarcoma trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Ewing's Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT02511132 lists 6 locations in 5 states (Texas, Arkansas, Florida).
Frequently Asked Questions
What is clinical trial NCT02511132 about?
NCT02511132 is a clinical study titled "A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma". 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 immun...
What is the current status of trial NCT02511132?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2016-02-10. Estimated completion is 2020-12-23.
What conditions does trial NCT02511132 study?
This clinical trial studies the following conditions: Ewing's Sarcoma.
What interventions are being tested in trial NCT02511132?
The interventions under investigation include: Docetaxel (DRUG), Temozolomide (DRUG), Gemcitabine (DRUG), Irinotecan (DRUG), Vigil (BIOLOGICAL).
Who is sponsoring clinical trial NCT02511132?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02511132 being conducted?
This trial has 6 study locations across Arkansas, Florida, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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