Testing Sodium Thiosulfate to Protect Hearing During Medulloblastoma Treatment
Official title: A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This trial is testing whether an added drug can lower hearing loss from medulloblastoma treatment.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT05382338
- Stage of testing
- Phase 3
- Conditions studied
- Childhood Medulloblastoma
Where it is running
This trial lists 111 sites.
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Alabama
- Children's Hospital of Alabama (Birmingham)
- USA Health Strada Patient Care Center (Mobile)
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Arizona
- Phoenix Childrens Hospital (Phoenix)
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Arkansas
- Arkansas Children's Hospital (Little Rock)
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California
- Loma Linda University Medical Center (Loma Linda)
- Miller Children's and Women's Hospital Long Beach (Long Beach)
- Children's Hospital Los Angeles (Los Angeles)
- Valley Children's Hospital (Madera)
- Kaiser Permanente-Oakland (Oakland)
- Children's Hospital of Orange County (Orange)
- University of California Davis Comprehensive Cancer Center (Sacramento)
- Rady Children's Hospital - San Diego (San Diego)
- UCSF Medical Center-Mission Bay (San Francisco)
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Canada
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) (Québec)
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Colorado
- Children's Hospital Colorado (Aurora)
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Connecticut
- Connecticut Children's Medical Center (Hartford)
- Yale University (New Haven)
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Delaware
- Alfred I duPont Hospital for Children (Wilmington)
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District of Columbia
- Children's National Medical Center (Washington D.C.)
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Florida
- Golisano Children's Hospital of Southwest Florida (Fort Myers)
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital (Hollywood)
- Nemours Children's Clinic-Jacksonville (Jacksonville)
- University of Miami Miller School of Medicine-Sylvester Cancer Center (Miami)
- Nicklaus Children's Hospital (Miami)
- Arnold Palmer Hospital for Children (Orlando)
- Nemours Children's Hospital (Orlando)
- Nemours Children's Clinic - Pensacola (Pensacola)
- Johns Hopkins All Children's Hospital (St. Petersburg)
- Saint Joseph's Hospital/Children's Hospital-Tampa (Tampa)
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Georgia
- Children's Healthcare of Atlanta - Arthur M Blank Hospital (Atlanta)
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Hawaii
- Kapiolani Medical Center for Women and Children (Honolulu)
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Illinois
- University of Illinois (Chicago)
- OSF Children's Hospital of Illinois (Peoria)
- Southern Illinois University School of Medicine (Springfield)
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Indiana
- Riley Hospital for Children (Indianapolis)
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Iowa
- Blank Children's Hospital (Des Moines)
- University of Iowa/Holden Comprehensive Cancer Center (Iowa City)
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Kentucky
- Norton Children's Hospital (Louisville)
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Louisiana
- Children's Hospital New Orleans (New Orleans)
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Manitoba
- CancerCare Manitoba (Winnipeg)
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Maryland
- Sinai Hospital of Baltimore (Baltimore)
- Johns Hopkins University/Sidney Kimmel Cancer Center (Baltimore)
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Massachusetts
- Massachusetts General Hospital Cancer Center (Boston)
- Dana-Farber Cancer Institute (Boston)
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Michigan
- C S Mott Children's Hospital (Ann Arbor)
- Children's Hospital of Michigan (Detroit)
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital (Grand Rapids)
- Corewell Health Children's (Royal Oak)
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Minnesota
- Children's Hospitals and Clinics of Minnesota - Minneapolis (Minneapolis)
- Mayo Clinic in Rochester (Rochester)
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Mississippi
- University of Mississippi Medical Center (Jackson)
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Missouri
- Children's Mercy Hospitals and Clinics (Kansas City)
- Cardinal Glennon Children's Medical Center (St Louis)
- Washington University School of Medicine (St Louis)
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Nebraska
- Children's Hospital and Medical Center of Omaha (Omaha)
- University of Nebraska Medical Center (Omaha)
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New Jersey
- Saint Peter's University Hospital (New Brunswick)
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital (New Brunswick)
- Newark Beth Israel Medical Center (Newark)
- Saint Joseph's Regional Medical Center (Paterson)
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New York
- Albany Medical Center (Albany)
- Roswell Park Cancer Institute (Buffalo)
- The Steven and Alexandra Cohen Children's Medical Center of New York (New Hyde Park)
- Laura and Isaac Perlmutter Cancer Center at NYU Langone (New York)
- Mount Sinai Hospital (New York)
- Stony Brook University Medical Center (Stony Brook)
- State University of New York Upstate Medical University (Syracuse)
- Montefiore Medical Center - Moses Campus (The Bronx)
- New York Medical College (Valhalla)
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North Carolina
- UNC Lineberger Comprehensive Cancer Center (Chapel Hill)
- Carolinas Medical Center/Levine Cancer Institute (Charlotte)
- East Carolina University (Greenville)
- Wake Forest University Health Sciences (Winston-Salem)
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North Dakota
- Sanford Broadway Medical Center (Fargo)
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Nova Scotia
- IWK Health Centre (Halifax)
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Ohio
- Children's Hospital Medical Center of Akron (Akron)
- Cincinnati Children's Hospital Medical Center (Cincinnati)
- Rainbow Babies and Childrens Hospital (Cleveland)
- Nationwide Children's Hospital (Columbus)
- Dayton Children's Hospital (Dayton)
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital (Toledo)
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Oklahoma
- University of Oklahoma Health Sciences Center (Oklahoma City)
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Oregon
- Legacy Emanuel Children's Hospital (Portland)
- Oregon Health and Science University (Portland)
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Pennsylvania
- Geisinger Medical Center (Danville)
- Children's Hospital of Philadelphia (Philadelphia)
- Children's Hospital of Pittsburgh of UPMC (Pittsburgh)
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Quebec
- Centre Hospitalier Universitaire Sainte-Justine (Montreal)
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont (Sherbrooke)
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Rhode Island
- Rhode Island Hospital (Providence)
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South Carolina
- Prisma Health Richland Hospital (Columbia)
- BI-LO Charities Children's Cancer Center (Greenville)
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South Dakota
- Sanford USD Medical Center - Sioux Falls (Sioux Falls)
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Tennessee
- East Tennessee Childrens Hospital (Knoxville)
- Vanderbilt University/Ingram Cancer Center (Nashville)
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Texas
- Dell Children's Medical Center of Central Texas (Austin)
- Driscoll Children's Hospital (Corpus Christi)
- Medical City Dallas Hospital (Dallas)
- UT Southwestern/Simmons Cancer Center-Dallas (Dallas)
- El Paso Children's Hospital (El Paso)
- Children's Hospital of San Antonio (San Antonio)
- University of Texas Health Science Center at San Antonio (San Antonio)
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Virginia
- University of Virginia Cancer Center (Charlottesville)
- Children's Hospital of The King's Daughters (Norfolk)
- VCU Massey Comprehensive Cancer Center (Richmond)
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Washington
- Seattle Children's Hospital (Seattle)
- Providence Sacred Heart Medical Center and Children's Hospital (Spokane)
- Mary Bridge Children's Hospital and Health Center (Tacoma)
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Wisconsin
- University of Wisconsin Carbone Cancer Center - University Hospital (Madison)
- Marshfield Medical Center-Marshfield (Marshfield)
- Children's Hospital of Wisconsin (Milwaukee)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.