NCT07407582

Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)

Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor Malignancies
• Testicular Cancer
• Head and Neck Cancer
• Thoracic Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2026-04-30
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2026-02-12
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study