Recruiting

Phase 1

Pedmark with CisplatinTesting the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors

Sponsor:

City of Hope Medical Center

Code:

NCT07218913

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

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Audiometric Test

Cisplatin

Computed Tomography

Magnetic Resonance Imaging

Sodium Thiosulfate Anhydrous

Study Details

Brief summary:

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

Hearing Loss

Metastatic Malignant Germ Cell Tumor

Metastatic Malignant Nongerminomatous Germ Cell Tumor

Metastatic Malignant Testicular Non-Seminomatous Germ Cell Tumor

Metastatic Testicular Seminoma

Study ID

NCT07218913

Start date

Feb 19, 2026

Status verified date

Apr, 2026

Completion date

Jan 22, 2031

Anticipated

Primary completion date

Jan 22, 2031

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (SOC cisplatin)

Patients receive cisplatin IV over 60 minutes on days 1-5 or 2-5 of each SOC cisplatin-based chemotherapy regimen cycle. Cycles repeat every 21 days for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial.

experimental: Arm II (SOC cisplatin, Pedmark)

Patients receive cisplatin IV over 60 minutes on days 1-5 or 2-5 of each SOC cisplatin-based chemotherapy regimen cycle. Patients also receive Pedmark IV over 30 minutes, 6 hours after each SOC cisplatin infusion, on days 1-5 or 2-5 of each cycle. Cycles repeat every 21 days for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial.

Interventions

Audiometric Test

Ancillary studies

Cisplatin

Given IV

Computed Tomography

Undergo CT

Magnetic Resonance Imaging

Undergo MRI

Sodium Thiosulfate Anhydrous

Given IV

Primary outcome measure

Incidence of clinically meaningful ototoxicity [ Time Frame: Up to 6 months post-treatment ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Alex Chehrazi-Raffle

626-218-4772 achehraziraffle@coh.org

Principal Investigator:

Alex Chehrazi-Raffle

More Information

Sponsor

City of Hope Medical Center

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-04-17.