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This phase III trial compares memantine to placebo in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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 - 17 Years |
| Gender | All |
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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. |
NCT04939597 |
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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 |
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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 |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Nadia N Laack |
| Principal Investigator Affiliation | Children's Oncology Group |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Active, not recruiting |
| Countries | Puerto Rico, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Central Nervous System Carcinoma |
PRIMARY OBJECTIVE:
Experimental: Arm I (memantine hydrochloride)
Patients receive memantine hydrochloride orally PO QD for week 1 and then BID for weeks 2-24 in the absence of disease progression or unacceptable toxicity. Patients also complete cognitive testing over 20-30 minutes at baseline, end of radiation therapy, and at 3, 6, 12, 24, and 48 months. Patients undergo MRI and may optionally undergo blood sample collection throughout the trial.
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for week 1 and then BID for weeks 2-24 in the absence of disease progression or unacceptable toxicity. Patients also complete cognitive testing over 20-30 minutes at baseline, end of radiation therapy, and at 3, 6, 12, 24, and 48 months. Patients undergo MRI and may optionally undergo blood sample collection throughout the trial.
Procedure: - Biospecimen Collection
Undergo blood sample collection
Procedure: - Cognitive Assessment
Complete cognitive testing
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Drug: - Memantine Hydrochloride
Given PO
Drug: - Placebo Administration
Given PO
Other: - Questionnaire Administration
Ancillary studies
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
Address
Children's Hospital of Alabama
Birmingham, Alabama, 35233
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Providence Alaska Medical Center
Anchorage, Alaska, 99508
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Address
Banner Children's at Desert
Mesa, Arizona, 85202
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Address
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
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Address
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
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Address
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
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Address
Kaiser Permanente Downey Medical Center
Downey, California, 90242
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Address
Loma Linda University Medical Center
Loma Linda, California, 92354
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Address
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
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Address
Children's Hospital Los Angeles
Los Angeles, California, 90027
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Address
Valley Children's Hospital
Madera, California, 93636
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Address
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
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Address
Kaiser Permanente-Oakland
Oakland, California, 94611
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Address
Children's Hospital of Orange County
Orange, California, 92868
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Address
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
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Address
Rady Children's Hospital - San Diego
San Diego, California, 92123
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Address
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
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Address
Children's Hospital Colorado
Aurora, Colorado, 80045
Status
Address
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
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Address
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Status
Address
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
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Address
Children's National Medical Center
Washington, District of Columbia, 20010
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Address
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Status
Address
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
Status
Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Status
Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Status
Address
Nicklaus Children's Hospital
Miami, Florida, 33155
Status
Address
Miami Cancer Institute
Miami, Florida, 33176
Status
Address
AdventHealth Orlando
Orlando, Florida, 32803
Status
Address
Nemours Children's Hospital
Orlando, Florida, 32827
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Address
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
Status
Address
Tampa General Hospital
Tampa, Florida, 33606
Status
Address
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Status
Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Status
Address
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Status
Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Status
Address
University of Illinois
Chicago, Illinois, 60612
Status
Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Status
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Address
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
Status
Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
Status
Address
Blank Children's Hospital
Des Moines, Iowa, 50309
Status
Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Status
Address
Norton Children's Hospital
Louisville, Kentucky, 40202
Status
Address
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Status
Address
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Status
Address
Maine Children's Cancer Program
Scarborough, Maine, 04074
Status
Address
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Status
Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
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Address
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Status
Address
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Status
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Status
Address
Children's Hospital of Michigan
Detroit, Michigan, 48201
Status
Address
Michigan State University Clinical Center
East Lansing, Michigan, 48824
Status
Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Status
Address
Corewell Health Children's
Royal Oak, Michigan, 48073
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Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Status
Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
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Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Address
University of Missouri Children's Hospital
Columbia, Missouri, 65212
Status
Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Status
Address
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
Status
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
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Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
Status
Address
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Status
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Status
Address
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Status
Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Status
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Address
Morristown Medical Center
Morristown, New Jersey, 07960
Status
Address
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Status
Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Status
Address
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
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Address
Albany Medical Center
Albany, New York, 12208
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Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
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Address
Maimonides Medical Center
Brooklyn, New York, 11219
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Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
Status
Address
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
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Address
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
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Address
Mount Sinai Hospital
New York, New York, 10029
Status
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Status
Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
Status
Address
State University of New York Upstate Medical University
Syracuse, New York, 13210
Status
Address
Mission Hospital
Asheville, North Carolina, 28801
Status
Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Status
Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Status
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Address
East Carolina University
Greenville, North Carolina, 27834
Status
Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Status
Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Status
Address
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
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Address
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Status
Address
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Status
Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Status
Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
Status
Address
Dayton Children's Hospital
Dayton, Ohio, 45404
Status
Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
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Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Status
Address
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Status
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Address
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Status
Address
Geisinger Medical Center
Danville, Pennsylvania, 17822
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Address
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Status
Address
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
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Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Status
Address
Rhode Island Hospital
Providence, Rhode Island, 02903
Status
Address
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Status
Address
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Status
Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Status
Address
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Status
Address
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Status
Address
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Status
Address
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Status
Address
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Status
Address
Medical City Dallas Hospital
Dallas, Texas, 75230
Status
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Status
Address
El Paso Children's Hospital
El Paso, Texas, 79905
Status
Address
Cook Children's Medical Center
Fort Worth, Texas, 76104
Status
Address
M D Anderson Cancer Center
Houston, Texas, 77030
Status
Address
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Status
Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Status
Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
Status
Address
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Status
Address
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Status
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Status
Address
Carilion Children's
Roanoke, Virginia, 24014
Status
Address
Seattle Children's Hospital
Seattle, Washington, 98105
Status
Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Status
Address
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Status
Address
Madigan Army Medical Center
Tacoma, Washington, 98431
Status
Address
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Status
Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Status
Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Status
Address
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Status
Address
HIMA San Pablo Oncologic Hospital
Caguas, , 00726
