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Phase I/II Study of Pedmark® Sodium Thiosulfate for Hearing Protection During Cisplatin Treatment

This study is testing a drug called Pedmark® sodium thiosulfate (STS) to see if it can help prevent hearing loss in adults receiving cisplatin chemotherapy for solid tumors like testicular, head and neck, or thoracic cancers. Pedmark® STS is already approved for use in children and young adults to protect their hearing during cisplatin treatment, but more information is needed for adult patients. You might be able to join if you are at least 18 years old, have not had cancer treatment before, and meet other health criteria. The study will measure how well Pedmark® STS works to reduce hearing problems and how safe it is. This study plans to enroll 25 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 25 participants.
What's involved
Pedmark® STS will be given through an IV over 15-30 minutes, 6 hours after each cisplatin infusion. Your hearing will be checked at the start, after a certain amount of cisplatin, and 3 months after your cisplatin treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Your hearing will be checked 3 months after your cisplatin chemotherapy treatment is finished.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07407582

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Arizona
~25 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Pedmark® STS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin
Measured over Baseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment.

Conditions

Solid Tumor Malignancies
Testicular Cancer
Head and Neck Cancer
Thoracic Cancer

Explore related trials

Malignant Head and Neck NeoplasmMalignant Testicular NeoplasmSolid NeoplasmThoracic Neoplasm

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Lisa Davis, PharmD · STUDY_CHAIR · University of Arizona
  • Alejandro Recio-Boiles, MD · PRINCIPAL_INVESTIGATOR · University of Arizona

Who to contact

Alejandro Recio Boiles, MD
[email protected]
520-694-2873
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Efficacy of intravenous STS to reduce hearing impairment associated with cisplatinBaseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment.

    Proportion of participants with Brock grade ≥1 hearing loss determined from audiometry exams. The Brock ototoxicity classification and grading scale are as follows: Grade 0 = hearing threshold less than 40 dB HL at all test frequencies; Grade 1 = hearing threshold greater than or equal to 40 dB HL at 8 kHz only; Grade 2 = hearing threshold greater than or equal to 40 db HL at 4kHz and above; Grade 3 = hearing threshold greater than or equal to 40 dB HL at 2 kHz and above; Grade 4 = hearing threshold greater than or equal to 40 dB HL at 1 kHz and above.