Add Pedmark to cisplatin chemotherapy to prevent hearing loss in men with stage II–III metastatic testicular germ cell tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I randomized trial compares standard cisplatin-based chemotherapy with or without sodium thiosulfate (Pedmark) in adult men with stage II–III metastatic testicular germ cell tumors. Participants receive 3–4 cycles of standard cisplatin-containing regimens given on 21-day cycles, with the experimental arm also receiving Pedmark, and undergo serial audiometry and imaging (CT/MRI). The study measures incidence of clinically meaningful ototoxicity as the primary outcome and examines high-frequency hearing loss, severity/progression of ototoxicity, safety/tolerability, tinnitus, and disease response at six months as secondary and exploratory outcomes. Safety monitoring and audiometric testing are performed throughout treatment to track hearing changes and adverse events.

Why it matters

Who can join: the full rules

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 audiometry exams
* Age: ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1 or Karnofsky score ≥ 70
* Histologically confirmed germ cell tumor (seminoma or non-seminoma)
* Presence of metastatic disease (stage II or III)
* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
* Receiving first or second line cisplatin-based chemotherapy
* Planned cumulative cisplatin dose of ≥ 300mg/m\^2 (including previous treatment)
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* Platelets ≥ 100,000/mm\^3

  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
* Hemoglobin ≥ 9g/dL

  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement
* Total bilirubin ≤ 1.5 X upper limit of normal (ULN)

  * Patients with known Gilbert disease who have serum bilirubin level \< 3 x ULN may be enrolled
* Aspartate aminotransferase (AST) ≤ 3.0 x ULN
* Alanine aminotransferase (ALT) ≤ 3.0 x ULN
* Creatinine clearance of ≥ 60 mL/min per the Cockcroft-Gault formula or serum creatinine ≤ 1.5 x ULN
* \* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN

  * If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
* \* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN

  * If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
* Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 11 months after the last dose of cisplatin for injection

Exclusion Criteria:

* Any cisplatin-based therapies within 4 weeks prior to initiation of study treatment
* If cisplatin infusion during study is planned to be longer than 6 hours, as Pedmark safety and efficacy has not been established when administered following longer cisplatin infusions
* Chronic steroid use, defined as greater than prednisone 5 mg daily for longer than 21 days (steroids used as antiemetic during treatment is permitted)
* Concurrent use of other ototoxic drugs other than cisplatin (loop diuretics, aminoglycosides, etc)
* Patient must adhere to low sodium diet given other comorbidities
* History of severe hypersensitivity to sodium thiosulfate or any components such as sulfites or thiols
* Known symptomatic brain metastases, leptomeningeal carcinomatosis, or prior cranial irradiation
* Deemed cisplatin ineligible due to poor performance status, cardiac dysfunction, renal insufficiency, or significant peripheral neuropathy
* Greater than or equal to moderate hearing loss (HL) at baseline per World Health Organization (WHO) classification
* Unstable cardiac disease as defined by one of the following:

  * Cardiac events such as myocardial infarction (MI) within the past 6 months
  * NYHA (New York Heart Association) heart failure class III-IV
  * Uncontrolled atrial fibrillation or hypertension
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Alex Chehrazi-Raffle — City of Hope Medical Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.