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RECRUITING
NCT07218913
PHASE1

Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase I trial evaluates whether adding Pedmark to standard of care cisplatin-based chemotherapy reduces drug-induced ear damage (ototoxicity) in men with stage II-III testicular germ cell tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Cisplatin-induced ototoxicity remains a major concern in adult patients with germ cell tumors as nearly four out of five patients develop hearing loss after treatment. Cisplatin is thought to cause ear damage by the production of chemically reactive molecules called reactive oxygen species. These molecules can cause damage when their levels get too high. Pedmark may reduce the negative side effects of cisplatin by neutralizing these reactive molecules. Pedmark has been approved for reducing the risk of cisplatin-induced ototoxicity in pediatric patients and older patients with solid tumors that haven't spread to other parts of the body. Adding Pedmark to cisplatin-based chemotherapy treatment may reduce ototoxicity in adult men with stage I-III testicular metastatic germ cell tumors.

Official title: Phase 1 Trial of Pedmark in Men Receiving Cisplatin for Metastatic Germ Cell Tumor

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2026-03-04

Completion Date

2031-01-22

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

PROCEDURE

Audiometric Test

Ancillary studies

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Sodium Thiosulfate Anhydrous

Given IV

Locations (1)

City of Hope Medical Center

Duarte, California, United States