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NCT07218913 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Hearing Loss and Metastatic Malignant Germ Cell Tumor, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT07218913 is a Phase 1 study of Hearing Loss and Metastatic Malignant Germ Cell Tumor that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 44 participants, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07218913, a Phase 1 study of Hearing Loss and Metastatic Malignant Germ Cell Tumor, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Audiometric Test
- DRUG Sodium Thiosulfate Anhydrous
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2026-03-04 |
| Est. Completion | 2031-01-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07218913
The ClinicalTrials.gov registry entry for NCT07218913 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Hearing Loss appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT07218913 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT07218913 about?
NCT07218913 is a clinical study titled "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". 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 (metastati...
What is the current status of trial NCT07218913?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2026-03-04. Estimated completion is 2031-01-22.
What conditions does trial NCT07218913 study?
This clinical trial studies the following conditions: Hearing Loss, Metastatic Malignant Germ Cell Tumor, Metastatic Malignant Nongerminomatous Germ Cell Tumor, Metastatic Malignant Testicular Non-Seminomatous Germ Cell Tumor, Metastatic Testicular Seminoma.
What interventions are being tested in trial NCT07218913?
The interventions under investigation include: Computed Tomography (PROCEDURE), Cisplatin (DRUG), Magnetic Resonance Imaging (PROCEDURE), Audiometric Test (PROCEDURE), Sodium Thiosulfate Anhydrous (DRUG).
Who is sponsoring clinical trial NCT07218913?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07218913 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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