52
Participants
Start Date
March 31, 2016
Primary Completion Date
September 30, 2020
Study Completion Date
August 31, 2021
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."
Childrens Hospital Los Angeles, Los Angeles
Children's Hospital Los Angeles
OTHER