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Ototoxicity, Drug-InducedEarly Phase 1NCT05756660

Sodium Thiosulfate Otoprotection During Salvage Cisplatin Therapy

A Early Phase 1 study testing Sodium Thiosulfate in people with Ototoxicity, Drug-Induced, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This study will attempt to demonstrate the efficacy of Sodium Thiosulfate (STS) in preventing hearing loss in patients re-treated with cisplatin-based therapy according to regimens Cisplatin and STS (regimen CS) and Cisplatin, STS and Vorinostat/SAHA (regimen CSS). Read more about this study

Who is it for?
Ages 1 month to 39 years
Conditions the study is for
Ototoxicity, Drug-Induced
What is being tested?
Sodium Thiosulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
1 Mar 2023to Jan 2027
Phase
Early Phase 1
Are there results?
None posted in the registry

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 1 month to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients must be > 1 month and ≤ 39 years old at study enrollment
  • Histologically proven, at time of diagnosis or relapse:
  • 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.
  • 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.
  • Stratum 2B: CSS: Relapsed/refractory Wilms tumor, Germ Cell Tumor, or Neuroblastoma
  • Patients must have a life expectancy of ≥ 8 weeks.
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  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study:
  • 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.
  • Immunotherapy: Must not have received within 2 weeks of entry onto this study.
  • 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
  • Adequate Bone Marrow Function Defined as:
  • Peripheral absolute neutrophil count (ANC) greater than or equal to 750/uL
  • Platelet count greater than or equal to 75,000/uL (transfusion independent defined as no platelet transfusions within 7 days)
  • Hemoglobin greater than or equal to 8.0 g/dL (may receive red blood cell transfusions)
  • Adequate Liver Function Defined As:
  • Total OR direct bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and
  • Aspartate aminotransferase (AST) or Alanine transaminase (ALT) < 10x ULN
  • Adequate Renal Function Defined As:
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 30 mL/min/1.73 m2
  • Baseline Audiology Requirements:
  • 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

Who cannot join

  • 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:
  • 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
  • Lactating females who plan to breastfeed their infants.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Cisplatin and Sodium Thiosulfate Otoprotection With or Without SAHA/Vorinostat Histone Deacetylase Inhibition for Relapsed/Refractory Hepatoblastoma and Other Embryonal Tumors

This study will attempt to demonstrate the efficacy of Sodium Thiosulfate (STS) in preventing hearing loss in patients re-treated with cisplatin-based therapy according to regimens Cisplatin and STS (regimen CS) and Cisplatin, STS and Vorinostat/SAHA (regimen CSS).

Read the detailed description

This trial will assess the effect of STS in preventing subsequent hearing loss when patients are re-challenged with cisplatin therapy at relapse/progression, as well as the efficacy of cisplatin/STS or cisplatin/STS/SAHA for patients with relapsed hepatoblastoma, Wilms, Germ Cell Tumor (GCT) and Neuroblastoma stratified by initial cisplatin sensitivity. Important pharmacokinetic measurements focused on cisplatin and STS in children, with varying degrees of renal function, will be assessed. Such pharmacokinetic data will fill a current gap in our clinical knowledge base and enable safer use of such agents for all children with such cancers, regardless of kidney function, in the future.

Being tested
Sodium Thiosulfate
Keywords
Cisplatin, Sodium Thiosulfate, Relapsed/Refractory Hepatoblastoma, PedMark, Embryonal Tumor
Medical subject headings
Ototoxicity, Hepatoblastoma, Neoplasms, Germ Cell and Embryonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium ThiosulfateDrug

    Also called Cisplatin, Vorinostat/ SAHA

    This goal of this study is to evaluate the efficacy of the proposed regimens in patients with relapsed/refractory platinum pre-treated patients with Hepatoblastoma, Wilms tumor, Germ Cell Tumor (GCT), and Neuroblastoma. The patients' initial cisplatin response (hepatoblastoma) and diagnosis will determine their treatment regimen on this study.

Study groups in NCT05756660
Study groupRoleWhat they receive
Stratum 1- Regimen CSExperimentalCisplatin sensitive/no progression on cisplatin (when given at first diagnosis)
Receives: Drug: Sodium Thiosulfate
Stratum 2A- Regimen CSSExperimentalCisplatin resistant or progressed on cisplatin after initial response (when given at first diagnosis)
Receives: Drug: Sodium Thiosulfate
Stratum 2B- Regimen CSSExperimentalWilms tumor, GCT, Neuroblastoma
Receives: Drug: Sodium Thiosulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevention of hearing loss

    To demonstrate the efficacy of Sodium Thiosulfate (STS) in preventing hearing loss in patients re-treated with cisplatin-based therapy according to regimens Cisplatin/STS (CS) and Cisplatin/STS/SAHA (CSS)

    Measured: Through study completion up to 5 years

Secondary outcomes (5)

  1. Prevention of hearing loss and tumor reduction

    Number of patients with minimal hearing loss as measure by audiogram evaluations. Number of patients with positive tumor response as measured by Response Evaluation Criteria in Solid Tumors (RECIST).

    Measured: Through study completion up to 5 years

  2. Number of Participants with Treatment-Related Adverse Events

    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: Through study completion up to 5 years

  3. Stratum 1 efficacy

    Arm A/CS: To describe the clinical efficacy of CS, as defined by objective response, in patients with relapsed/refractory Hepatoblastoma that was initially sensitive to cisplatin and without progression on cisplatin

    Measured: Through study completion up to 5 years

  4. Stratum 2 efficacy

    To define the clinical efficacy of CSS, as defined by objective response, in patients with initial cisplatin refractory Hepatoblastoma or in patients who progress on cisplatin

    Measured: Through study completion up to 5 years

  5. Maximum Plasma Concentration [Cmax]

    To investigate the concentration of cisplatin in patients with varying degrees of renal dysfunction

    Measured: Through study completion up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start1 Mar 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Why it stopped: This study will be closing at CCHMC and may be transferred to a principal investigator at another insitutiton.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Three strata are identified for this study: Stratum 1: Cisplatin sensitive/no progression on cisplatin (when given at first diagnosis): Regimen Cisplatin/STS (CS) Stratum 2A: Cisplatin resistant or progressed on cisplatin after initial response (when given at first diagnosis): Regimen Cisplatin/STS/SAHA (CSS) Stratum 2B: Wilms tumor, Germ Cell tumor, Neuroblastoma: Regimen CSS Within each of the 3 eligible strata, patients will be enrolled and directly assigned to their respective protocol therapy, yielding 3 independent single-arm cohorts. Patients will receive protocol therapy for up to 6 3-week cycles before moving to follow-up.
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05756660
Sponsor's protocol ID
CSS-JG-2201
Status last verified
Oct 2026
First submitted
9 Feb 2023
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Sodium Thiosulfate in people with Ototoxicity, Drug-Induced, run by Children's Hospital Medical Center, Cincinnati 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 23 inclusion and 9 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: paused, as of the sponsor's last update on 22 Oct 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevention of hearing loss (time frame: Through study completion up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05756660.

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 22 Oct 2026.

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