Sodium thiosulfate to protect hearing during cisplatin therapy in adults with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This combined Phase 1/2 trial will assess the safety and potential to prevent cisplatin-related hearing impairment when Pedmark is given with the cisplatin regimen. Eligible adults with untreated solid tumors will receive standard cisplatin therapy along with the otoprotectant. The study uses a cisplatin-based regimen with a cumulative dose of at least 200 mg/m2 and evaluates safety and hearing outcomes. The trial builds on pediatric data where the drug is approved for otoprotection in young patients. Results will inform whether this adult population can similarly benefit from Pedmark.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting

Study contacts

• Principal investigator: Alejandro Recio-Boiles, MD — University of Arizona
• Study coordinator: Alejandro Recio Boiles, MD
• Email: areciomd@arizona.edu
• Phone: 520-694-2873

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.