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.
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…
Contacts
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