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Neuroblastoma Maintenance Therapy Trial

NCT02679144 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2026-01-21

No results posted yet for this 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

Interventions

DRUG

Difluoromethylornithine (DFMO)

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.

Sponsors & Collaborators

  • Beat NB Cancer Foundation

    collaborator OTHER

  • Team Parker for Life

    collaborator UNKNOWN

  • Giselle Sholler

    lead OTHER

Principal Investigators

  • Giselle Sholler, MD · Beat Childhood Cancer at Atrium Health

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2028-02-29
Completion
2033-02-28
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02679144 on ClinicalTrials.gov