Hearing loss shield tested in kids with liver cancer
NCT ID NCT05756660
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether sodium thiosulfate can prevent hearing loss in children and young adults (ages 1 month to 39 years) who are receiving cisplatin chemotherapy for relapsed or hard-to-treat liver tumors and other embryonal cancers. Some participants also get vorinostat. The goal is to see if hearing can be protected without reducing the cancer-fighting effect of cisplatin.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 39 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must be \> 1 month and ≤ 39 years old at study enrollment * Histologically proven, at time of diagnosis or relapse: 1. Stratum 1: Arm CS (Cisplatin/STS): Previously chemosensitive to cisplatin defined as an AFP drop of 1 log (90%) and/or an objective tumor response of 30% or greater on imaging while receiving cisplatin. 2. Stratum 2A: Cisplatin/STS/SAHA (CSS): Previously chemosensitive but with noted subsequent progression on cisplatin or initially chemoresistant to cisplatin (all other hepatoblastoma patients). Resistance to cisplatin is defined as rising alpha-fetoprotein (AFP) x 2 consecutive measurements or imaging progression including growth of known lesions or new lesions while patient is receiving a cycle of chemotherapy containing cisplatin or relapse noted within 3 months of last cisplatin administration. 3. Stratum 2B: CSS: Relapsed/refractory Wilms tumor, Germ Cell Tumor, or Neuroblastoma * Patients must have a life expectancy of ≥ 8 weeks. * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study: 1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study. Previous SAHA administration is permitted. Tacrolimus and Sirolimus with levels \<= 10 ng/ml are not considered myelosuppressive. 2. Immunotherapy: Must not have received within 2 weeks of entry onto this study. 3. Radiation therapy (RT): greater than or equal to 2 weeks for local palliative RT (small port); greater than or equal to 6 months must have elapsed if prior craniospinal RT or if greater than or equal to 50% radiation of pelvis * Patients may not be enrolled on another clinical trial or receiving any other investigational therapies (within 2 weeks prior to study enrollment). * Organ Function Requirements 1. Adequate Bone Marrow Function Defined as: 1. Peripheral absolute neutrophil count (ANC) greater than or equal to 750/uL 2. Platelet count greater than or equal to 75,000/uL (transfusion independent defined as no platelet transfusions within 7 days) 3. Hemoglobin greater than or equal to 8.0 g/dL (may receive red blood cell transfusions) 2. Adequate Liver Function Defined As: 1. Total OR direct bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and 2. Aspartate aminotransferase (AST) or Alanine transaminase (ALT) \< 10x ULN 3. Adequate Renal Function Defined As: 1. Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 30 mL/min/1.73 m2 * Baseline Audiology Requirements: 1. Subjects must have a successful audiology examination prior to enrollment. Patients may have Boston grade III or IV hearing loss and still be eligible to enroll as long as they did not receive 3 or more cycles of cisplatin during upfront therapy WITH sodium thiosulfate. There is no specific baseline hearing level/grade requirement beyond that to be eligible, but the baseline level of hearing must be clearly established and recorded Exclusion Criteria: * Patients with any uncontrolled, intercurrent illness including, but not limited to, uncontrolled infection * Patients with symptomatic congestive heart failure (defined as Grade 2 or higher heart failure per CTCAE version 5.0) * Patients with Renal Tubular Acidosis (RTA) as evidenced by serum bicarbonate \< 16 mmol/L and serum phosphate ≤ 2 mg/dL (or \< 0.8 mmol/L) without supplementation. Patients requiring electrolyte supplementation for RTA will be permitted if bicarbonate ≥16 mmol/L and phosphate \> 2mg/dL after at least 7 days of stable supplementation regimen * Pregnancy and Breastfeeding: 1. Female patients who are pregnant or breast-feeding will not be entered in the study. A negative pregnancy test within 72 hours of starting therapy is required for female patients of childbearing potential 2. Lactating females who plan to breastfeed their infants. 3. Sexually active patients of reproductive potential must agree to use an effective contraceptive method for the duration of their study participation * Patients on tacrolimus and/or sirolimus with levels of either targeted \> 10 ng/mL * Known allergy to any component of CS or CSS therapy, as indicated
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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