NAC to Prevent Cisplatin-induced Hearing Loss
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Liver Neoplasms
- Neuroectodermal Tumors, Primitive
- Osteosarcoma
- Other Childhood Cancers Using Cisplatin-based Regimens
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 21 years
- Gender
- Both males and females
Description
The study is a dose-finding study of N-acetylcysteine (NAC) to protect hearing in children receiving cisplatin for the treatment of their cancer. NAC also has potential to protect the kidneys from cisplatin toxicity. The study uses a 3+3 dose-escalation scheme to determine the dose of NAC necessary ...
The study is a dose-finding study of N-acetylcysteine (NAC) to protect hearing in children receiving cisplatin for the treatment of their cancer. NAC also has potential to protect the kidneys from cisplatin toxicity. The study uses a 3+3 dose-escalation scheme to determine the dose of NAC necessary to achieve serum levels consistent with hearing protection in pre-clinical animal models. Three dose levels are predefined. Once the maximum tolerated dose is determined, an expansion cohort will then be enrolled to further evaluate tolerability as well as intra-patient and inter-patient variability in achieved serum levels. An option to enroll in a separate arm for study assessments only is available for those who do not wish to receive NAC. Hearing loss in the cohort will be assessed in the entire cohort in comparison to historical and non-treated children to evaluate for trends toward efficacy.
Tracking Information
- NCT #
- NCT02094625
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Etan Orgel, MD MS Children's Hospital Los Angeles
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