NCT02679144

Neuroblastoma Maintenance Therapy Trial

NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 441 (estimated)
• Sponsor: Giselle Sholler · Academic / Other
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

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

• Neuroblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2028-02-01
• Completion: 2033-02-01
• First posted: 2016-02-10
• Last updated: 2026-01-21

Locations

49 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study