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COMPLETED Phase 2

A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma

NCT02511132 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 22 participants
Start Date 2016-02-10
Est. Completion 2020-12-23
Phase Phase 2

Sponsor

Gradalis

5 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gradalis, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02511132 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, Arkansas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02511132?

The interventions under investigation include: Docetaxel (DRUG), Temozolomide (DRUG), Gemcitabine (DRUG), Irinotecan (DRUG), Vigil (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02511132?

This trial is sponsored by Gradalis, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial