Clinical trial for Hearing Loss
Official title 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
ClinicalTrials.gov ID: NCT07218913
What this study is testing
What is Cisplatin?
Cisplatin is an investigational IV chemotherapy drug being studied for preventing hearing loss in adult men with metastatic testicular germ cell tumors. Cisplatin is designed to kill tumor cells by forming DNA crosslinks that block cell replication.
Also referred to as Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol-AQ, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding the drug Pedmark to standard chemotherapy can prevent or reduce hearing damage caused by the chemo drug cisplatin.
- Who it's for
- The study is looking for men with stage II or III testicular cancer that has spread to other parts of the body.
- What's involved
- Participants will receive standard cisplatin-based chemotherapy along with Pedmark. They will undergo regular hearing tests to monitor for any damage.
- Time commitment
- The duration and specific visit schedule are not detailed in the provided text.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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 how well it works has not been established when...
- 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
See the full eligibility 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
- 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 how well it works 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
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.