NCT05382338RecruitingPhase 3
A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
This phase III trial tests two hypotheses in patients with low-risk and average-risk medulloblastoma. Medulloblastoma is a type of cancer that occurs in the back of the brain. The term, risk, refers to the chance of the cancer coming back after treatment. Subjects with low-risk medulloblastoma typically have a lower chance of the cancer coming back than subjects with average-risk medulloblastoma. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects or unintended health conditions that arise due to treatment include learning difficulties, hearing loss or other issues in performing daily activities. Standard therapy for newly diagnosed average-risk or low-risk medulloblastoma includes surgery, radiation therapy, and chemotherapy (including cisplatin). Cisplatin may cause hearing loss as a side effect. In the average-risk medulloblastoma patients, this trial tests whether the addition of sodium thiosulfate (STS) to standard of care chemotherapy and radiation therapy reduces hearing loss. Previous studies with STS have shown that it may help reduce or prevent hearing loss caused by cisplatin. In the low-risk medulloblastoma patients, the study tests whether a less intense therapy (reduced radiation) can provide the same benefits as the more intense therapy. The less intense therapy may cause fewer side effects. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. The overall goals of this study are to see if giving STS along with standard treatment (radiation therapy and chemotherapy) will reduce hearing loss in medulloblastoma patients and to compare the overall outcome of patients with medulloblastoma treated with STS to patients treated without STS on a previous study in order to make sure that survival and recurrence of tumor is not worsened.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 225 (estimated)
- First submitted
- 15 Apr 2022
- Start date
- 20 Feb 2023
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Children's Oncology Group
- Diseases
- Childhood cancers
- NCT number
- NCT05382338
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 225
- From 20 Feb 2023 to the primary completion date, 31 Dec 2029
- 111 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
- 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
Other illness
- 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 any known hypersensitivity to STS, sulfates/sulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril)
Who the study is looking for
- 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
Age in the registry: 4 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (111)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IWK Health Centre Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| Centre Hospitalier Universitaire Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
| CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
| Children's Hospital Medical Center of Akron Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Active, not recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Massachusetts General Hospital Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Suspended |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Carolinas Medical Center/Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Rainbow Babies and Childrens Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Prisma Health Richland Hospital Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Recruiting |
| Medical City Dallas Hospital Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Blank Children's Hospital Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Children's Hospital of Michigan Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| El Paso Children's Hospital Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Golisano Children's Hospital of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| BI-LO Charities Children's Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Kapiolani Medical Center for Women and Children Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Nemours Children's Clinic-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Children's Mercy Hospitals and Clinics Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| East Tennessee Childrens Hospital Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Loma Linda University Medical Center Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
| Miller Children's and Women's Hospital Long Beach Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Norton Children's Hospital Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Valley Children's Hospital Coordinator of this site? Confirm its status | Madera | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| Nicklaus Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| USA Health Strada Patient Care Center Coordinator of this site? Confirm its status | Mobile | United States | Recruiting |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Suspended |
| Newark Beth Israel Medical Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Saint Peter's University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| The Steven and Alexandra Cohen Children's Medical Center of New York Coordinator of this site? Confirm its status | New Hyde Park | United States | Suspended |
| Children's Hospital New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Children's Hospital of The King's Daughters Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| Kaiser Permanente-Oakland Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Children's Hospital and Medical Center of Omaha Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Arnold Palmer Hospital for Children Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Saint Joseph's Regional Medical Center Coordinator of this site? Confirm its status | Paterson | United States | Recruiting |
| Nemours Children's Clinic - Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| OSF Children's Hospital of Illinois Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Phoenix Childrens Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Legacy Emanuel Children's Hospital Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Corewell Health Children's Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Children's Hospital of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Rady Children's Hospital - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| UCSF Medical Center-Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Providence Sacred Heart Medical Center and Children's Hospital Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Cardinal Glennon Children's Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
| Johns Hopkins All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Mary Bridge Children's Hospital and Health Center Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| Saint Joseph's Hospital/Children's Hospital-Tampa Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Recruiting |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Alfred I duPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.