This clinical trial tests the safety, side effects, best dose and how well giving sodium thiosulfate after standard of care cisplatin works to reduce hearing impairment for adults receiving cisplatin for solid tumor cancer. Cisplatin treatment can be ototoxic, which means it may cause damage to the inner ear, leading to hearing impairment. Sodium thiosulfate is given after the cisplatin and is a substance that is used in medicine as an antidote to cyanide poisoning and to decrease side effects of the anticancer drug cisplatin by binding to it. Giving sodium thiosulfate may be a safe and/or effective way to reduce hearing impairment for adults receiving cisplatin for solid tumor cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07407582.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - TucsonStatus: Active
Contact: Alejandro Recio Boiles
Phone: 520-626-8096
PRIMARY OBJECTIVE:
I. Efficacy of intravenous sodium thiosulfate (STS) to reduce hearing impairment associated with cisplatin.
SECONDARY OBJECTIVES:
I. Tolerability of the administration of STS based on the adverse events.
II. Cisplatin pharmacokinetics and fraction remaining to be excreted at 4- and 6-hours post-cisplatin.
EXPLORATORY OBJECTIVES:
I. Outcome event-free survival comparison to historical control data.
II. Incidence of nephrotoxicity.
III. Risk factors for cisplatin induced ototoxicity (CIO).
IV. Health-related quality of life (QOL).
V. Hearing-specific quality of life.
OUTLINE:
Patients receive sodium thiosulfate intravenously (IV), over 15-30 minutes, starting 6 hours after the completion of each standard of care cisplatin infusion, in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging and blood sample collection throughout the study.
After completion of study treatment, patients are followed up until they have undergone a post-treatment audiometry evaluation, typically within 3 months of completion of cisplatin treatment.
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorAlejandro Recio Boiles