Actively Recruiting
A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
Led by Children's Oncology Group · Updated on 2026-05-05
225
Participants Needed
105
Research Sites
358 weeks
Total Duration
On this page
Sponsors
C
Children's Oncology Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 4 to 21 years at enrollment
- Suspected newly diagnosed medulloblastoma by institutional diagnosis
- Signed informed consent for eligibility screening and molecular characterization
- Submission of required specimens within 5 days of surgery
- Rapid central pathology, molecular, imaging, and audiology review confirming diagnosis and eligibility
- No metastatic disease on brain or spine MRI
- Residual tumor area less than or equal to 1.5 cm squared after surgery
- Negative lumbar cerebrospinal fluid cytology obtained no sooner than 14 days after surgery
- Weight over 10 kilograms
- Enrollment and start of therapy within 31 days after diagnostic surgery
- Adequate blood counts and kidney and liver function within 7 days prior to enrollment
- Central nervous system function adequate; seizure disorder allowed if well controlled
- Normal hearing in at least one ear confirmed by central audiology review
- Compliance with all institutional, FDA, and NCI human study requirements
You will not qualify if you...
- Presence of metastatic disease by MRI or cerebrospinal fluid cytology
- Inability to undergo lumbar puncture for cerebrospinal fluid assessment
- Prior radiation or chemotherapy treatment except surgery or corticosteroids
- Known allergy to sodium thiosulfate, sulfates/sulfites, or related thiol agents
- Pregnancy or breastfeeding
- Sexually active patients of reproductive potential not agreeing to use effective contraception during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 105 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
Actively Recruiting
3
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
4
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
5
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
6
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
7
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
8
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
9
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
10
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
11
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
12
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
13
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
14
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
15
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
16
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
17
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
18
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
19
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
20
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
21
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
22
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
23
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
24
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
25
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
26
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
27
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
28
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
29
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
30
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
31
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Actively Recruiting
32
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
33
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
34
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
35
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
36
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
37
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
38
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
39
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
40
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
41
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
42
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
43
Corewell Health Children's
Royal Oak, Michigan, United States, 48073
Actively Recruiting
44
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
45
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
46
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Suspended
47
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
48
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
49
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
50
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
51
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
52
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
53
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
54
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
55
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Actively Recruiting
56
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
57
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
58
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
59
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
60
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
61
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
62
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
63
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
64
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
65
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
66
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
67
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
68
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
69
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
70
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
71
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
72
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
73
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
74
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
75
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
76
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
77
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
78
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
79
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
80
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
81
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
82
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
83
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
84
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
85
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
86
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Suspended
87
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
88
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
89
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
90
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
91
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
92
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
93
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
94
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
95
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
96
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
97
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
98
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
99
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
100
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
101
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
102
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
103
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
104
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
105
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada, G1V 4G2
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here