Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT07218913

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

Led by City of Hope Medical Center · Updated on 2026-04-17

44

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent and assent if appropriate
  • Willing and able to participate in baseline and follow-up hearing tests
  • Age 18 years or older
  • ECOG performance status 0 or 1 or Karnofsky score 70 or higher
  • Histologically confirmed testicular germ cell tumor (seminoma or non-seminoma)
  • Presence of metastatic disease (stage II or III)
  • Fully recovered from acute toxic effects of prior cancer therapy (except hair loss) to grade 1 or less
  • Receiving first or second line cisplatin-based chemotherapy
  • Planned cumulative cisplatin dose of 300 mg/m2 or more including previous treatment
  • Measurable disease per RECIST 1.1 criteria
  • Absolute neutrophil count 1500/mm3 or higher
  • Platelets 100,000/mm3 or higher (no platelet transfusions within 14 days unless due to disease)
  • Hemoglobin 9 g/dL or higher (no red blood cell transfusions within 14 days unless due to disease)
  • Total bilirubin 1.5 times upper limit of normal or less (up to 3 times for Gilbert disease patients)
  • AST 3 times upper limit of normal or less
  • ALT 3 times upper limit of normal or less
  • Creatinine clearance 60 mL/min or higher or serum creatinine 1.5 times upper limit of normal or less
  • INR or prothrombin time 1.5 times upper limit of normal or less if not on anticoagulants; therapeutic range if on anticoagulants
  • aPTT 1.5 times upper limit of normal or less if not on anticoagulants; therapeutic range if on anticoagulants
  • Male patients with female partners of reproductive potential agree to use effective contraception during treatment and for 11 months after last cisplatin dose
Not Eligible

You will not qualify if you...

  • Received cisplatin-based therapy within 4 weeks before study treatment
  • Planned cisplatin infusion longer than 6 hours
  • Chronic steroid use over prednisone 5 mg daily for more than 21 days (except steroid use as antiemetic during treatment)
  • Concurrent use of other ototoxic drugs besides cisplatin (e.g., loop diuretics, aminoglycosides)
  • Unable to follow a low sodium diet
  • History of severe allergy to sodium thiosulfate or related compounds
  • Known symptomatic brain metastases, leptomeningeal carcinomatosis, or prior cranial radiation
  • Ineligible for cisplatin due to poor performance status, heart problems, kidney problems, or significant peripheral neuropathy
  • Moderate or greater hearing loss at baseline per WHO classification
  • Unstable heart disease including recent heart attack within 6 months, severe heart failure (NYHA class III-IV), uncontrolled atrial fibrillation or high blood pressure
  • Investigator judgment that participant cannot comply with study procedures

AI-Screening

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Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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