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Pedmark to Reduce Hearing Damage in Testicular Cancer Treatment

This study is testing if adding Pedmark (sodium thiosulfate anhydrous) to standard cisplatin chemotherapy can reduce hearing damage (ototoxicity) in men with stage II-III metastatic testicular germ cell tumors. Cisplatin is a common chemotherapy that can cause hearing loss in many patients. Researchers believe cisplatin causes ear damage by creating harmful molecules. This trial aims to see if Pedmark can protect your ears while still effectively treating your cancer. You may be eligible if you are a man aged 18 or older with metastatic testicular germ cell tumors and meet other health criteria. The main goal is to measure how many patients experience significant hearing loss up to 6 months after treatment.

Study design
This is a phase I interventional study with a planned enrollment of 44 men, comparing Pedmark plus cisplatin to cisplatin alone.
What's involved
You would receive cisplatin intravenously, potentially with Pedmark, over several days for 3-4 cycles. You will also have regular hearing tests (audiometric tests), CT scans, and/or MRI scans.
Compensation
Not stated in the trial record.
Follow-up
The study will measure hearing loss up to 6 months after treatment, and disease assessment will occur 6 months post-primary treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~44 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Audiometric TestCisplatinComputed TomographyMagnetic Resonance ImagingSodium Thiosulfate Anhydrous

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of clinically meaningful ototoxicity
Measured over Up to 6 months post-treatment

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
Stage II Testicular Cancer AJCC v8
Stage III Testicular Cancer AJCC v8

Explore related trials

Testicular Germ Cell Tumor

NCT07218913

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alex Chehrazi-Raffle · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Alex Chehrazi-Raffle
[email protected]
626-218-4772
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Incidence of clinically meaningful ototoxicityUp to 6 months post-treatment

    Will compare the proportion of patients who experience clinically meaningful ototoxicity between adults with germ cell tumor (GCT) receiving Pedmark plus cisplatin-based chemotherapy compared to those receiving cisplatin-based chemotherapy alone. Clinically meaningful ototoxicity is defined by a \> 20 decibel (dB) threshold shift at a single frequency, a \> 10 dB shift at two adjacent frequencies, or a change to "no response" at three consecutive frequencies as long as these frequencies fall between 250-8000 hertz (Hz) which impacts speech understanding. The corresponding 95% confidence interval (CI) will be constructed using the Clopper-Pearson exact method. The proportion of patients who develop clinically meaningful ototoxicity will be compared between arms using a one-sided Fisher's exact test.