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NCT02679144 · ClinicalTrials.gov registry record · Phase 2

Neuroblastoma Maintenance Therapy Trial

A Phase 2 study of Neuroblastoma, sponsored by Giselle Sholler.

Recruiting
Registry status
Phase 2
Development phase
441
Enrollment target
20
Study locations

NCT02679144 is a Phase 2 study of Neuroblastoma that is actively recruiting participants, run by Giselle Sholler. The registered enrollment target is 441 participants, above the 234-participant average among 94 other Neuroblastoma trials with a reported enrollment target (88% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT02679144, a Phase 2 study of Neuroblastoma, is actively recruiting participants, sponsored by Giselle Sholler.

RECRUITING
Registry status
Phase 2
Development phase
441 participants
Enrollment target
20
Study locations

Study Summary

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.

Conditions Studied

Neuroblastoma

Interventions

  • DRUG Difluoromethylornithine (DFMO)

Study Locations (20)

Florida

  • University of Florida - Gainesville
  • Arnold Palmer Hospital for Children - Orlando
  • All Children's Hospital Johns Hopkins Medicine - St. Petersburg
  • St. Joseph's Children's Hospital - Tampa

California

  • UCSF Benioff Children's Hospital Oakland- - Oakland
  • Rady Children's Hospital - San Diego

Kentucky

  • Kentucky Children's Hospital - Lexington
  • Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine - Louisville

Massachusetts

  • Tufts Medical Center - Boston
  • University of Massachusetts Medical School Worcester - Worcester

Alabama

  • University of Alabama, Children's of Alabama - Birmingham

Arkansas

  • Arkansas Children's Hospital - Little Rock

Colorado

  • Rocky Mountain Pediatric Hematology - Denver

Connecticut

  • Connecticut Children's Hospital - Hartford

Trial Details

FieldValue
Enrollment Target 441 participants
Start Date 2016-02
Est. Completion 2033-02
Phase Phase 2

Sponsor

Giselle Sholler

20 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02679144

The ClinicalTrials.gov registry entry for NCT02679144 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 441 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 94 other Neuroblastoma trials with a reported enrollment target (88% higher). The listed sponsor is Giselle Sholler, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which Difluoromethylornithine (DFMO) is the first listed.

NCT02679144 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, California, Kentucky.

Frequently Asked Questions

What is clinical trial NCT02679144 about?

NCT02679144 is a clinical study titled "Neuroblastoma Maintenance Therapy Trial". Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m...

What is the current status of trial NCT02679144?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 441 participants. The study started on 2016-02. Estimated completion is 2033-02.

What conditions does trial NCT02679144 study?

This clinical trial studies the following conditions: Neuroblastoma.

What interventions are being tested in trial NCT02679144?

The interventions under investigation include: Difluoromethylornithine (DFMO) (DRUG).

Who is sponsoring clinical trial NCT02679144?

This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02679144 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.