Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hearing Loss
Metastatic Malignant Germ Cell Tumor
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 ...
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate the incidence of clinically meaningful ototoxicity in adults with metastatic germ cell tumor (GCT) receiving sodium thiosulfate anhydrous (Pedmark) plus cisplatin-based...
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)
Key Trial Info
Start Date :
February 4 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 17 2030
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07218913
Start Date
February 4 2026
End Date
February 17 2030
Last Update
October 21 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010