Hearing LossPhase 1NCT07218913
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
A Phase 1 study testing Audiometric Test, Cisplatin and Computed Tomography in people with Hearing Loss and Metastatic Malignant Germ Cell Tumor, run by City of Hope Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hearing Loss, Metastatic Malignant Germ Cell Tumor, Metastatic Malignant Nongerminomatous Germ Cell Tumor
- What is being tested?
- Audiometric Test, Cisplatin and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to 22 Jan 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Alex Chehrazi-Raffle, 626-218-4772, achehraziraffle@coh.org
Alex Chehrazi-Raffle
About this study
Official title: Phase 1 Trial of Pedmark in Men Receiving Cisplatin for Metastatic Germ Cell Tumor
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the incidence of clinically meaningful ototoxicity in adults with metastatic germ cell tumor (GCT) receiving sodium thiosulfate anhydrous (Pedmark) plus cisplatin-based chemotherapy compared to those receiving cisplatin-based chemotherapy alone.
SECONDARY OBJECTIVES:
- Assess the incidence of high-frequency ototoxicity (affecting frequencies within 8000-12,500 Hz) between adults in both arms.
II. Assess the severity and progression of ototoxicity between adults in both arms.
III. Determine the safety and tolerability of Pedmark plus cisplatin-based chemotherapy compared to cisplatin-based chemotherapy alone.
IV. Examine the efficacy of Pedmark plus cisplatin-based chemotherapy compared to cisplatin-based chemotherapy alone.
EXPLORATORY OBJECTIVES:
- Evaluate the incidence of tinnitus between adults in both arms. II. Disease assessment 6 months post-primary treatment in both arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cisplatin intravenously (IV) over 60 minutes on days 1-5 or 2-5 of each standard of care (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 computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the trial.
ARM II: 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.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year and then per SOC for year 2.
- 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
- Being tested
- Audiometric Test, Cisplatin, Computed Tomography, Magnetic Resonance Imaging, Sodium Thiosulfate Anhydrous
- Medical subject headings
- Hearing Loss, Seminoma, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiometric TestProcedure or surgery
Also called Audiometric Testing, Audiometry, Hearing Test
Ancillary studies
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Sodium Thiosulfate AnhydrousDrug
Also called Disodium Thiosulfate, Sodium Thiosulfate, Anhydrous, Thiosulfuric Acid, Disodium Salt
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (SOC cisplatin) | Active comparator | 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. Receives: Procedure: Audiometric Test; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging |
| Arm II (SOC cisplatin, Pedmark) | Experimental | 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. Receives: Procedure: Audiometric Test; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Sodium Thiosulfate Anhydrous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically meaningful ototoxicity
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.
Measured: Up to 6 months post-treatment
Secondary outcomes (4)
Incidence of high-frequency ototoxicity
Will compare the proportion of patients who experience high-frequency ototoxicity between adults with GCT receiving Pedmark plus cisplatin-based chemotherapy compared to those receiving cisplatin-based chemotherapy alone. High frequency ototoxicity is defined by a > 20 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 8000-12,00 Hz. Will be estimated with 95% CIs by the Clopper-Pearson exact method. The proportion of patients who develop high-frequency ototoxicity will be compared between arms using a one-sided Fisher's exact test.
Measured: Up to 6 months post-treatment
Degree of ototoxicity
Audiometry results between adults with GCT receiving Pedmark plus cisplatin-based chemotherapy will be compared to those receiving cisplatin-based chemotherapy alone. This will be decided by the audiologist per World Health Organization classification. Longitudinal changes in degree of ototoxicity will be summarized descriptively and analyzed using repeated-measures models to compare changes from baseline across time points between treatment arms.
Measured: Baseline to 1, 3, and 6 months post-treatment
Incidence of adverse events (AEs)
Will evaluate the rate of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in adults with GCT receiving Pedmark plus cisplatin-based chemotherapy compared to those receiving cisplatin-based chemotherapy alone. The safety evaluation will be based on all patients that received at least one dose of the drug and will include AEs, serious AEs, and changes from baseline in laboratory evaluations, vital signs, and physical examinations. Summaries will be provided overall and by treatment group. The number and percentage of subjects reporting will be summarized overall and by CTCAE grade. All patients will be evaluable for toxicity from the time of their first treatment with cisplatin-based chemotherapy ± Pedmark.
Measured: Up to 6 months post-treatment
Progression-free survival (PFS)
Will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1. The difference in PFS between treatment arms will be estimated using the Kaplan-Meier method, with survival curves generated for each group. Statistical comparison of PFS between arms will be conducted using the log-rank test.
Measured: From start of treatment to time of progressive disease or death, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start19 Feb 2026
- Primary completion22 Jan 2031 (estimated)
- Study completion22 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alex Chehrazi-Raffle, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218913
- Sponsor's protocol ID
- 25407
- Other IDs
- NCI-2025-07298, 25407, P30CA033572
- Status last verified
- Apr 2026
- First submitted
- 17 Oct 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of Pedmark in Men Receiving Cisplatin for Metastatic Germ Cell Tumor
- ClinicalTrials.gov ID
- NCT07218913
- Acronym / sponsor ID
- 25407
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 22 Jan 2031 (estimated)
- Study completion
- 22 Jan 2031 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the incidence of clinically meaningful ototoxicity in adults with metastatic germ cell tumor (GCT) receiving sodium thiosulfate anhydrous (Pedmark) plus cisplatin-based chemotherapy compared to those receiving cisplatin-based chemotherapy alone.
SECONDARY OBJECTIVES:
- Assess the incidence of high-frequency ototoxicity (affecting frequencies within 8000-12,500 Hz) between adults in both arms.
II. Assess the severity and progression of ototoxicity between adults in both arms.
III. Determine the safety and tolerability of Pedmark plus cisplatin-based chemotherapy compared to cisplatin-based chemotherapy alone.
IV. Examine the efficacy of Pedmark plus cisplatin-based chemotherapy compared to cisplatin-based chemotherapy alone.
EXPLORATORY OBJECTIVES:
- Evaluate the incidence of tinnitus between adults in both arms. II. Disease assessment 6 months post-primary treatment in both arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cisplatin intravenously (IV) over 60 minutes on days 1-5 or 2-5 of each standard of care (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 computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the trial.
ARM II: 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.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year and then per SOC for year 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (SOC cisplatin) | Active comparator | Procedure: Audiometric Test, Drug: Cisplatin, Procedure: Computed Tomography, Procedure: Magnetic Resonance ImagingPatients 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. |
| Arm II (SOC cisplatin, Pedmark) | Experimental | Procedure: Audiometric Test, Drug: Cisplatin, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Drug: Sodium Thiosulfate AnhydrousPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Documented informed consent of the participant and/or legally authorized representative
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiometric TestAlso: Audiometric Testing, Audiometry, Hearing TestAncillary studies | Procedure or surgery | Arm I (SOC cisplatin), Arm II (SOC cisplatin, Pedmark) |
| CisplatinAlso: Abiplatin, Blastolem, Briplatin, CDDPGiven IV | Drug | Arm I (SOC cisplatin), Arm II (SOC cisplatin, Pedmark) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm I (SOC cisplatin), Arm II (SOC cisplatin, Pedmark) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Arm I (SOC cisplatin), Arm II (SOC cisplatin, Pedmark) |
| Sodium Thiosulfate AnhydrousAlso: Disodium Thiosulfate, Sodium Thiosulfate, Anhydrous, Thiosulfuric Acid, Disodium SaltGiven IV | Drug | Arm II (SOC cisplatin, Pedmark) |
Primary outcome
Incidence of clinically meaningful ototoxicity
Time frame: Up 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.
4 secondary outcomes
Incidence of high-frequency ototoxicity
Time frame: Up to 6 months post-treatment
Degree of ototoxicity
Time frame: Baseline to 1, 3, and 6 months post-treatment
Incidence of adverse events (AEs)
Time frame: Up to 6 months post-treatment
Progression-free survival (PFS)
Time frame: From start of treatment to time of progressive disease or death, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Related trials for Hearing Loss
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
Hearing Loss
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Chehrazi-Raffle principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Audiometric Test, Cisplatin and Computed Tomography in people with Hearing Loss and Metastatic Malignant Germ Cell Tumor, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically meaningful ototoxicity (time frame: Up to 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.