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Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
Sponsor: University of Arizona
Summary
The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.
Official title: Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-04-30
Completion Date
2028-04-30
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
Pedmark® STS
Pedmark® STS (20 g/m2) will be given via intravenous infusion over 15-30 minutes, starting 6 hours after the completion of cisplatin infusion. Pedmark® STS will be given each day of cisplatin infusion.
Locations (1)
University of Arizona Cancer Center
Tucson, Arizona, United States