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Can a simple drug save Kids' hearing during chemo?

NCT ID NCT05382338

Disease control Sponsor: Children's Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 4 times

Summary

This study tests whether sodium thiosulfate can reduce hearing loss caused by cisplatin chemotherapy in children with medulloblastoma, a type of brain cancer. It also explores whether low-risk patients can be treated with less intense radiation to reduce side effects. About 225 children aged 4 to 21 will take part. The goal is to improve quality of life without harming survival chances.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sodium thiosulfate
What this could lead to
If it works, this could reduce hearing loss in children treated with cisplatin for medulloblastoma, and allow less intense therapy for low-risk patients with fewer side effects.
What could go wrong
This is a phase 3 trial, but results are not yet known. Sodium thiosulfate may not prevent hearing loss as hoped, and reduced therapy could lead to higher recurrence rates. Hearing loss and other side effects remain possible.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 225 people

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

Started

Feb 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 21 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: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

childhood medulloblastoma medulloblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Childhood medulloblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    110 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Alfred I duPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202-3591, United States

  • Arnold Palmer Hospital for Children

    RECRUITING

    Orlando, Florida, 32806, United States

  • BI-LO Charities Children's Cancer Center

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Blank Children's Hospital

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • C S Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

    RECRUITING

    Québec, G1V 4G2, Canada

  • CancerCare Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Cardinal Glennon Children's Medical Center

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Carolinas Medical Center/Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Centre Hospitalier Universitaire Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308, United States

  • Children's Hospital New Orleans

    RECRUITING

    New Orleans, Louisiana, 70118, United States

  • Children's Hospital and Medical Center of Omaha

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Children's Hospital of Alabama

    ACTIVE_NOT_RECRUITING

    Birmingham, Alabama, 35233, United States

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of San Antonio

    RECRUITING

    San Antonio, Texas, 78207, United States

  • Children's Hospital of The King's Daughters

    RECRUITING

    Norfolk, Virginia, 23507, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Children's Mercy Hospitals and Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

    Contact Email: •••••@•••••

  • Children's National Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Corewell Health Children's

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dayton Children's Hospital

    RECRUITING

    Dayton, Ohio, 45404, United States

  • Dell Children's Medical Center of Central Texas

    RECRUITING

    Austin, Texas, 78723, United States

  • Driscoll Children's Hospital

    RECRUITING

    Corpus Christi, Texas, 78411, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • East Tennessee Childrens Hospital

    RECRUITING

    Knoxville, Tennessee, 37916, United States

  • El Paso Children's Hospital

    RECRUITING

    El Paso, Texas, 79905, United States

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

    Contact Email: •••••@•••••

  • Golisano Children's Hospital of Southwest Florida

    RECRUITING

    Fort Myers, Florida, 33908, United States

  • IWK Health Centre

    RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

    Contact Email: •••••@•••••

  • Johns Hopkins All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente-Oakland

    RECRUITING

    Oakland, California, 94611, United States

  • Kapiolani Medical Center for Women and Children

    RECRUITING

    Honolulu, Hawaii, 96826, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    RECRUITING

    New York, New York, 10016, United States

    Contact Email: •••••@•••••

  • Legacy Emanuel Children's Hospital

    RECRUITING

    Portland, Oregon, 97227, United States

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, 92354, United States

  • Marshfield Medical Center-Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

    Contact Email: •••••@•••••

  • Mary Bridge Children's Hospital and Health Center

    RECRUITING

    Tacoma, Washington, 98405, United States

    Contact Email: •••••@•••••

  • Massachusetts General Hospital Cancer Center

    SUSPENDED

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical City Dallas Hospital

    RECRUITING

    Dallas, Texas, 75230, United States

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Miller Children's and Women's Hospital Long Beach

    RECRUITING

    Long Beach, California, 90806, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nemours Children's Clinic - Pensacola

    RECRUITING

    Pensacola, Florida, 32504, United States

    Contact Email: •••••@•••••

  • Nemours Children's Clinic-Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Hospital

    RECRUITING

    Orlando, Florida, 32827, United States

  • New York Medical College

    RECRUITING

    Valhalla, New York, 10595, United States

  • Newark Beth Israel Medical Center

    RECRUITING

    Newark, New Jersey, 07112, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

    Contact Email: •••••@•••••

  • OSF Children's Hospital of Illinois

    RECRUITING

    Peoria, Illinois, 61637, United States

    Contact Email: •••••@•••••

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Phoenix Childrens Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Prisma Health Richland Hospital

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

    Contact Email: •••••@•••••

  • Providence Sacred Heart Medical Center and Children's Hospital

    RECRUITING

    Spokane, Washington, 99204, United States

  • Rady Children's Hospital - San Diego

    RECRUITING

    San Diego, California, 92123, United States

  • Rainbow Babies and Childrens Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    RECRUITING

    Tampa, Florida, 33607, United States

  • Saint Joseph's Regional Medical Center

    RECRUITING

    Paterson, New Jersey, 07503, United States

  • Saint Peter's University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Sanford Broadway Medical Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford USD Medical Center - Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57117-5134, United States

    Contact Email: •••••@•••••

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Sinai Hospital of Baltimore

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62702, United States

  • State University of New York Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • Stony Brook University Medical Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    SUSPENDED

    New Hyde Park, New York, 11040, United States

  • UCSF Medical Center-Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

    Contact Email: •••••@•••••

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • USA Health Strada Patient Care Center

    RECRUITING

    Mobile, Alabama, 36604, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Illinois

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Iowa/Holden Comprehensive Cancer Center

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Valley Children's Hospital

    RECRUITING

    Madera, California, 93636, United States

    Contact Email: •••••@•••••

  • Vanderbilt University/Ingram Cancer Center

    SUSPENDED

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••