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Hearing loss shield tested in kids with liver cancer

NCT ID NCT05756660

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

1 month to 39 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

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Other studies related to the condition(s) this trial covers.