BridgeMD
New treatment option 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 medicine, given as an infusion into a vein, being studied as a potential treatment for hearing loss.
Also referred to as Abiplatin, Blastolem.
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 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.
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.