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

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor Malignancies, Testicular Cancer, Head and Neck Cancer, Thoracic Cancer

In brief

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.

Key facts

Study ID

NCT07407582

Run by

University of Arizona

People needed

25

Starts

2026-05-18

Expected to finish

2028-04-30

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants have provided informed consent prior to initiation of any study-specific activities.
• At least 18 years of age, male or female, at the time of signing the informed consent.
• ECOG Performance Status 0-1
• Histologically or cytologically confirmed treatment-naïve cancer.
• Scheduled to receive an FDA-approved, on-label indication, standard of care systemic cisplatin-based regimen (at least 200 mg/m2 cumulative dose) for any untreated any solid malignancy deemed by the treating physician

You may not qualify if…

• Prior cisplatin exposure due to a cancer treatment history
• Concurrent ototoxic medication unable to be safely discontinued or switched to a non-toxic alternative
• Planned radiation to the head or neck prior to, during, or within 3 months of completion of cisplatin
• History of severe hypersensitivity to sulfite, sodium thiosulfate, or any components
• Baseline serum sodium > 145 mmol/L or any grade ≥ 3 electrolyte abnormality
• Cisplatin infusion duration greater than 6 hours
• Females during pregnancy or breastfeeding, and childbearing potential, unwilling to use a method of contraception during treatment
• Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment
• Subject likely not to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject's and investigator's knowledge.
• History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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