Recruiting
Phase 1
Phase 2

STS with Cisplatin

Sponsor:

University of Arizona

Code:

NCT07407582

Conditions

Solid Tumor Malignancies

Testicular Cancer

Head and Neck Cancer

Thoracic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pedmark® STS

Study Details

Brief 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

Study ID

NCT07407582

Start date

May 18, 2026

Status verified date

Jun, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Treatment Arm

Study participants will receive Pedmark® STS via intravenous infusion after the completion of their standard of care cisplatin infusion.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Alejandro Recio Boiles, MD

520-694-2873areciomd@arizona.edu

Michele Chu-Pilli

520-626-1183chum@arizona.edu

Locations

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85724

Principal Investigator:

Alejandro Recio-Boiles, MD

More Information

Sponsor

University of Arizona

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Cisplatin
  • Otoprotectant
  • Cancer
  • Hearing Impairment
  • Sodium Thiosulfate
  • Adults
  • Solid Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-06-18.