Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Neuroblastoma Maintenance Therapy Trial

NCT02679144 · View on ClinicalTrials.gov ↗

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

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

65 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. 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 441 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Giselle Sholler, which has 65 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 Neuroblastoma appearing as the primary indexed condition, and to 1 intervention — of which Difluoromethylornithine (DFMO) 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: NCT02679144 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, California, Kentucky. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02679144?

The interventions under investigation include: Difluoromethylornithine (DFMO) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02679144?

This trial is sponsored by Giselle Sholler, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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