Sodium Thiosulfate for Hearing Loss During Cancer Treatment

Overseen By Michele Chu-Pilli

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Arizona

Must be taking: Cisplatin

Must not be taking: Ototoxic medications

Disqualifiers: Prior cisplatin, Pregnancy, Severe hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Up to 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Lisa Davis, PharmD

Principal Investigator

University of Arizona

Alejandro Recio-Boiles, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

Adults at least 18 years old with various untreated solid cancers, including testicular and lung cancer, who are about to start standard cisplatin chemotherapy can join. They must be relatively healthy (ECOG 0-1) and have agreed to the study's procedures.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer has not been treated before and was confirmed by a lab test.

I have given my consent to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pedmark® STS via intravenous infusion after standard cisplatin therapy

Up to 12 months

Multiple visits as per treatment schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up visit at 3 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Sodium Thiosulfate

Trial Overview

The trial is testing Pedmark® sodium thiosulfate (STS), a drug aimed at protecting against hearing loss in adults receiving cisplatin chemotherapy for solid tumors. The effectiveness of STS has been shown in younger patients but needs evaluation in adults.

How Is the Trial Designed?

Group I: Study Treatment Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Fennec Pharma

Collaborator

Trials

1