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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02511132
The ClinicalTrials.gov registry entry for NCT02511132 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 7 other Ewing's Sarcoma trials with a reported enrollment target (73% lower). The listed sponsor is Gradalis, which has 13 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.