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

Recruiting Phase 1 Interventional Study
Hearing Loss Metastatic Malignant Germ Cell Tumor Metastatic Malignant Nongerminomatous Germ Cell Tumor Metastatic Malignant Testicular Non-Seminomatous Germ Cell Tumor Metastatic Testicular Seminoma Stage II Testicular Cancer AJCC v8 Stage III Testicular Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
City of Hope Medical Center · Other
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About This Trial
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 killi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Willing and able to sign informed consent form * Willing and able to participate in baseline and serial audiom…
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