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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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 4 Years - 21 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05382338 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Children's Oncology Group |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Ralph Salloum |
Principal Investigator Affiliation | Children's Oncology Group |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Childhood Medulloblastoma |
PRIMARY OBJECTIVES:
Experimental: Treatment (chemoradiotherapy, maintenance)
See Detailed Description.
Procedure: - Audiometric Test
Ancillary studies
Procedure: - Auditory Brainstem Response
Ancillary studies
Procedure: - Biospecimen Collection
Undergo CSF and blood sample collection
Drug: - Cisplatin
Given IV
Drug: - Cyclophosphamide
Given IV
Drug: - Lomustine
Given PO
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Other: - Quality-of-Life Assessment
Ancillary studies
Radiation: - Radiation Therapy
Undergo radiation therapy
Drug: - Sodium Thiosulfate
Given IV
Other: - Survey Administration
Ancillary studies
Drug: - Vincristine
Given IV
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Suspended
Address
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Status
Recruiting
Address
USA Health Strada Patient Care Center
Mobile, Alabama, 36604
Status
Recruiting
Address
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Status
Recruiting
Address
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Status
Recruiting
Address
Loma Linda University Medical Center
Loma Linda, California, 92354
Status
Recruiting
Address
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
Status
Recruiting
Address
Children's Hospital Los Angeles
Los Angeles, California, 90027
Status
Recruiting
Address
Valley Children's Hospital
Madera, California, 93636
Status
Recruiting
Address
Kaiser Permanente-Oakland
Oakland, California, 94611
Status
Recruiting
Address
Children's Hospital of Orange County
Orange, California, 92868
Status
Recruiting
Address
Rady Children's Hospital - San Diego
San Diego, California, 92123
Status
Recruiting
Address
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
Status
Recruiting
Address
Children's Hospital Colorado
Aurora, Colorado, 80045
Status
Recruiting
Address
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Status
Recruiting
Address
Children's National Medical Center
Washington, District of Columbia, 20010
Status
Recruiting
Address
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Status
Recruiting
Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Status
Recruiting
Address
Nicklaus Children's Hospital
Miami, Florida, 33155
Status
Recruiting
Address
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Status
Recruiting
Address
Nemours Children's Hospital
Orlando, Florida, 32827
Status
Recruiting
Address
University of Illinois
Chicago, Illinois, 60612
Status
Recruiting
Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
Status
Recruiting
Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Status
Recruiting
Address
Norton Children's Hospital
Louisville, Kentucky, 40202
Status
Recruiting
Address
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Status
Recruiting
Address
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Status
Recruiting
Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Status
Recruiting
Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Children's Hospital of Michigan
Detroit, Michigan, 48201
Status
Recruiting
Address
Corewell Health Children's
Royal Oak, Michigan, 48073
Status
Recruiting
Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Recruiting
Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Status
Recruiting
Address
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Status
Recruiting
Address
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Status
Recruiting
Address
Albany Medical Center
Albany, New York, 12208
Status
Suspended
Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
Status
Recruiting
Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
Status
Recruiting
Address
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Status
Recruiting
Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
Status
Recruiting
Address
State University of New York Upstate Medical University
Syracuse, New York, 13210
Status
Recruiting
Address
New York Medical College
Valhalla, New York, 10595
Status
Recruiting
Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Status
Recruiting
Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Status
Recruiting
Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Status
Recruiting
Address
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Status
Recruiting
Address
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Status
Recruiting
Address
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Status
Recruiting
Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
Status
Recruiting
Address
Dayton Children's Hospital
Dayton, Ohio, 45404
Status
Recruiting
Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
Status
Recruiting
Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Status
Recruiting
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Recruiting
Address
Geisinger Medical Center
Danville, Pennsylvania, 17822
Status
Recruiting
Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Status
Recruiting
Address
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Status
Recruiting
Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Status
Recruiting
Address
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Status
Recruiting
Address
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Status
Recruiting
Address
Medical City Dallas Hospital
Dallas, Texas, 75230
Status
Recruiting
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Status
Recruiting
Address
El Paso Children's Hospital
El Paso, Texas, 79905
Status
Recruiting
Address
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Status
Recruiting
Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Recruiting
Address
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Status
Recruiting
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Status
Recruiting
Address
Seattle Children's Hospital
Seattle, Washington, 98105
Status
Recruiting
Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Status
Recruiting
Address
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Status
Suspended
Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Status
Recruiting
Address
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226