Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Active:	Yes
Cancer Type:	Neuroblastoma	NCT ID:	NCT04301843
Trial Phases:	Phase II	Protocol IDs:	BCC015 (primary) NCI-2021-01126
Eligibility:	0 - 31 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Giselle Sholler
NCI Full Details:	http://clinicaltrials.gov/show/NCT04301843

Summary

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

Objectives

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.

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

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