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)

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.