NCT04301843

Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (estimated)
• Sponsor: Giselle Sholler · Academic / Other
• Sex: All
• Age: 31 Years
• Healthy volunteers: Not accepted

Summary

Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study in combination with etoposide for subjects with relapsed/refractory neuroblastoma.

Detailed description

Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study in combination with etoposide for subjects with relapsed/refractory neuroblastoma. In this study subjects will receive six 21-day cycles of Etoposide and DFMO followed by an additional 630 days of DFMO alone. Subjects will be evaluated in 3 arms: • Arm 1: Subjects who show no active disease after receiving any additional therapy for neuroblastoma that was refractory to standard induction/consolidation therapy. Refractory: Subjects with progressive disease on upfront therapy OR did not have at least PR on induction OR required additional second line therapy to achieve remission who are now in first remission. * Arm 2: Subjects who have previously relapsed and currently show no active disease (in CR2 or greater). * Arm 3: Subjects who are relapsed or refractory with active disease.- CLOSED TO ENROLLMENT

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Eflornithine	DFMO (difluoromethylornithine) will be given at a dose of 1000 mg/m2 BID on each day of study.

Timeline

• Start date: 2020-09-25
• Primary completion: 2028-10-01
• Completion: 2033-10-01
• First posted: 2020-03-10
• Last updated: 2026-02-03

Locations

31 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study