NAC to Prevent Cisplatin-induced Hearing Loss

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

September 30, 2020

Study Completion Date

August 31, 2021

Conditions
Neuroectodermal Tumors, PrimitiveLiver NeoplasmsOsteosarcomaOther Childhood Cancers Using Cisplatin-based Regimens
Interventions
DRUG

N-Acetylcysteine

"NAC will be administered intravenously over \~60 minutes starting 4 hours following completion of cisplatin chemotherapy.~Three dose levels have been pre-determined:~Dose Level 1: 225 mg/kg Dose Level 2: 300 mg/kg Dose Level 3: 450 mg/kg~Should Dose Level 3 exceed the MTD, the study will examine blood levels of NAC and if below the target blood level necessary for hearing protection, the study will de-escalate from Dose Level 3 to an intermediate Dose Level 2.5 and test a dose of 375 mg/kg.~As of August 2018: Dose escalation completed with MTD not reached. Dose level 3 (450mg/kg) selected for expansion with NAC."

Trial Locations (1)

90027

Childrens Hospital Los Angeles, Los Angeles

All Listed Sponsors
lead

Children's Hospital Los Angeles

OTHER

NCT02094625 - NAC to Prevent Cisplatin-induced Hearing Loss | Biotech Hunter | Biotech Hunter