Neuroblastoma Maintenance Therapy Trial

Official Title

NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

Summary:

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicentre, 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.

Trial Description

Primary Outcome:

• Number of participants with event free survival (EFS) during study.

• Length of time that participants experience Overall Survival (OS)
• Number of Participants with Adverse Events as a Measure of Safety and Tolerability
• Peak Plasma Concentration (Cmax)
• Area under the plasma concentration versus time curve (AUC)
• Time to reach Peak Plasma Concentration (Tmax)
• Number of participants with ODC (Ornithine decarboxylase) single nucleotide polymorphisms.

View this trial on ClinicalTrials.gov