Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-035
Prinicipal Investigator
Brown, Valerie
Phase
Phase II
Age Group
Children
Scope
National
Secondary Protocol No.
BCC015 DFMO
Title
Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
Objective
Primary Objective:
To evaluate the efficacy of difluoromethylornithine (DFMO) in combination with etoposide in patients with relapsed/refractory neuroblastoma, based upon:

Event free survival (EFS) from time of enrollment.

Secondary Objectives:
To evaluate the efficacy of difluoromethylornithine (DFMO) in combination with etoposide in patients with relapsed/refractory neuroblastoma, based upon:

Overall Survival (OS) from time of enrollment.

Response Rate for patients with active disease (Arm 3).

To monitor the safety and tolerability profile of difluoromethylornithine (DFMO) in combination with etoposide in pediatric and young adult patients with relapsed/refractory neuroblastoma
Applicable Disease Sites
Brain and Nervous System
Status
Open
Participating Institutions
Hershey Medical Center