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A Study of Sodium Thiosulfate to Reduce Hearing Loss in Childhood Medulloblastoma

This study is looking at ways to reduce hearing loss in children and young adults (ages 4-21) with newly diagnosed medulloblastoma, a type of brain cancer. It's testing if giving sodium thiosulfate during chemotherapy with cisplatin and cyclophosphamide can help prevent hearing loss. Researchers will compare hearing loss rates in participants receiving sodium thiosulfate to a group that did not receive it in a previous study. They will also track how long patients live without the cancer returning (event-free survival) and overall survival to make sure the treatment is still effective against the cancer. This study aims to improve the quality of life for patients undergoing treatment for medulloblastoma.

Study design
This study plans to enroll 225 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Participants will undergo audiometric tests (hearing tests), auditory brainstem response tests, and have CSF (spinal fluid) and blood samples collected. They will receive cisplatin and cyclophosphamide intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for event-free survival for up to 10 years from the start of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05382338

A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss

Recruiting
PHASE3Ages 4–21InterventionalTreatment
Children's Oncology Group
~225 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Audiometric TestAuditory Brainstem ResponseBiospecimen CollectionCisplatinCyclophosphamideLomustine

At a glance

Recruiting sites
107 of 111 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients with >= grade 2 hearing loss
Measured over At 4 weeks after the last dose of cisplatin
+1 more outcome measured

Conditions

Childhood Medulloblastoma

Explore related trials

MedulloblastomaMYC GeneMYCN Gene

NCT05382338

Where you'd take part

This study runs at 111 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Albany Medical Center

    Albany, New Yorkstudy coordinator listed

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delawarestudy coordinator listed

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Floridastudy coordinator listed

    Recruiting

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolinastudy coordinator listed

    Recruiting

  • Blank Children's Hospital

    Des Moines, Iowastudy coordinator listed

    Recruiting

  • C S Mott Children's Hospital

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, Canadastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ralph Salloum · PRINCIPAL_INVESTIGATOR · Children's Oncology Group

Who to contact

Site Public Contact
800-388-8721
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Eligibility criteria

Inclusion

PRE-ENROLLMENT: Patients must be ≥ 4 years and ≤ 21 years of age at the time of enrollment
PRE-ENROLLMENT: Patient is suspected to have newly-diagnosed medulloblastoma by institutional diagnosis
Please note: Patients with a pending result of CSF cytology tests are eligible for NCI-2014-02057 (APEC14B1-Central Nervous System \[CNS\]) and CNS/Medulloblastoma Pre Enrollment Eligibility Screening
PRE-ENROLLMENT: The patient and/or their parents or legal guardians must have signed informed consent for APEC14B1 Part A - Eligibility Screening and consent for the Molecular Characterization Initiative (MCI)
PRE-ENROLLMENT: The required specimens are projected to be submitted under APEC14B1-CNS as soon as possible, preferably within 5 days of definitive surgery
PRE-ENROLLMENT: All patients must have rapid central pathology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031.
Note: Patients with a pending result of CSF cytology tests are eligible for the rapid central pathology screening review. Confirmation of CSF negativity is needed for enrollment on the ACNS2031 protocol
PRE-ENROLLMENT: All patients must have rapid central molecular screening review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1, in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031
PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central imaging screening review under APEC14B1 prior to study enrollment on ACNS2031 step 1
Note: Patients must not have metastatic disease on cranial or spinal MRI. Patients with \> 1.5 cm\^2 residual tumor after initial surgical resection may undergo a second surgical resection prior to subsequent therapy to render them eligible for this study. The day of the second resection to remove residual tumor will be regarded as the day of definitive surgery (Day 0) and must be within a month (31 days) of the initial resection
PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central audiology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1
Patients must be \>= 4 years and =\< 21 years of age at the time of enrollment
Patients must be newly diagnosed and have eligibility confirmed by rapid central pathology and molecular screening reviews performed on APEC14B1 and via the Molecular Characterization Initiative
Average-risk cohort
Clinico-pathologic criteria:
M0 disease
No diffuse anaplastic histology AND
Molecular criteria:
SHH, p53wt, GLI2 normal, MYCN normal, no chromosome 14q loss
Group 3, MYC normal, no isochromosome 17q
Group 4, no chromosome 11 loss
Low-risk features cohort
Clinico-pathologic criteria:
M0 disease
No diffuse anaplastic histology AND
Molecular criteria:
Group 4, chromosome 11 loss
Patients must have negative lumbar CSF cytology
Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF. Ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study. Patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status. Patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated. Patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1. Patients must have =\< 1.5 cm\^2 cross-sectional area of residual tumor. Whole brain MRI with and without gadolinium and spine MRI with gadolinium must be performed
Patients must weigh \> 10 kg
Patients must be enrolled, and protocol therapy must be projected to begin, no later than 31 days after definitive diagnostic surgery (day 0)
Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment)
Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
Hemoglobin \>= 8.0 g/dL (may receive red blood cell count \[RBC\] transfusions) (within 7 days prior to enrollment)
A serum creatinine (within 7 days prior to enrollment) based on age/sex as follows:
4 to \< 6 years (age); 0.8 mg/dL (male) 0.8 mg/dL (female)
6 to \< 10 years (age); 1 mg/dL (male) 1 mg/dL (female)
10 to \< 13 years (age); 1.2 mg/dL (male) 1.2 mg/dL (female)
13 to \< 16 years (age); 1.5 mg/dL (male) 1.4 mg/dL (female)
\>= 16 years (age); 1.7 mg/dL (male) 1.4 mg/dL (female) OR a 24 hour urine Creatinine clearance \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment)
Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
Central nervous system function defined as:
Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
Patients must not be in status epilepticus, a coma or assisted ventilation at the time of study enrollment
Auditory function defined as:
Patients must have normal hearing (defined as International Society of Pediatric Oncology \[SIOP\] grade 0) in at least one ear confirmed by rapid central audiology review performed on APEC14B1 prior to enrollment
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion

Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible. Patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
Patients must not have any known hypersensitivity to STS, sulfates/sulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril)
Pregnancy and Breastfeeding:
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

What this trial measures

  • Percentage of patients with >= grade 2 hearing lossAt 4 weeks after the last dose of cisplatin

    Will estimate the number and percentage of patients with \>= grade 2 hearing loss using the society of pediatric oncology (SIOP) scale (defined as hearing threshold \>20 dB at \>= 4kHz) 4 weeks after the last dose of cisplatin. If hearing loss is observed in both ears, the worse ear will be used for this primary analysis.

  • Event-free survival (EFS)From initiation of the protocol treatment to the occurrence of disease progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 10 years

    Will estimate the EFS distribution using Kaplan-Meier (KM) method.