Clinical trialNCT03495921TerminatedPhase 3Interventional

A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide

SponsorGradalis, Inc.Enrollment32Ewing Family of TumorsEwing SarcomaEwing's Sarcoma MetastaticEwing's Tumor MetastaticEwing's Tumor RecurrentNeoplasms+7 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The goal of this clinical trial was to compare participants with first relapse or refractory Ewing's sarcoma when treated with investigational product (Vigil) in addition to the standard treatment of irinotecan and temozolomide compared to the standard treatment of irinotecan and temozolomide alone. The main question it aimed to answer is "Will participants who receive Vigil in addition to irinotecan and temozolomide have a prolonged time to progression and improved quality of life compared to the participants who receive irinotecan and temozolomide alone?".

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

John Nemunaitis, MD
Gradalis, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Nicklaus Children'S Hospital
Miami, Florida, United States
Dana-Farber/boston Children'S Cancer and Blood Disorders
Boston, Massachusetts, United States
Washington University Siteman Cancer Center
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke Children'S Hospital and Health Center; Duke Cancer Institute
Durham, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Texas Oncology - Pediatrics
Dallas, Texas, United States
Cook Children'S Medical Center
Fort Worth, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Irinotecan →Temozolomide →Vigil

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Aug 2018
Primary completion: 20 Jan 2022
Completion: 20 Jan 2022
Last update posted: 26 Apr 2023
Registered enrollment: 32
Registry id: NCT03495921

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.