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A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for Primary Central Nervous System Tumors
Study Purpose
This phase III trial compares memantine to usual treatment 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.
Recruitment Criteria
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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 |
Inclusion Criteria:
- - >= 4 and < 18 years at time of study entry.
- - Patients must weigh 15 kg or greater at time of study entry.
- - Primary central nervous system tumors that have not received prior cranial radiotherapy.
- - Planned focal, cranial or craniospinal radiation treatment for a primary central nervous system tumor.
- - The patient must have receptive and expressive language skills in English, French or Spanish since the neurocognitive function and quality of life (QOL) assessment instruments are available in these languages only.
- - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: - Age: 4 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 male; 0.8 female.
- - Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 male; 1 female.
- - Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 male; 1.2 female.
- - Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 male; 1.4 female.
- - Age: >= 16 years; Maximum serum creatinine (mg/dL): 1.7 male; 1.4 female.
- - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age.
- - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L.
- - Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L.
- - The patient must be able to undergo magnetic resonance imaging.
- - 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.
Exclusion Criteria:
- - Life expectancy of less than 18 months.
- - Pre-existing conditions: - Any contraindication or allergy to study drug (memantine or placebo) - Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months or since initiating anticonvulsant therapy.
- - History of neurodevelopmental disorder such as Down syndrome, Fragile X, William's Syndrome, intellectual disability (presumed intelligence quotient [IQ] < 70), etc.
- - Co-morbid systemic illnesses, psychiatric conditions, social situations, or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or would limit compliance with the study requirements.
- - Patients with a motor, visual, or auditory condition that precludes participation in computerized neurocognitive assessments.
- - Patients with any medical condition or taking medications that lead to alterations of urine pH towards the alkaline condition (e.g., renal tubular acidosis, carbonic anhydrase inhibitors, sodium bicarbonate) - Personal history of prior cranial or craniospinal radiotherapy is not allowed.
- - Note: Prior anti-cancer therapy including surgery, chemotherapy, targeted agents are allowed as per standard of care clinical treatment guidelines.
- - Female patients who are pregnant are excluded since fetal toxicities and teratogenic effects have been noted for the study drug.
- - Lactating females who plan to breastfeed their infants.
Trial Details
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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 | Recruiting |
| Countries | Puerto Rico, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Central Nervous System Carcinoma |
PRIMARY OBJECTIVE:
- I. To determine the efficacy, as measured by the slope of change of the Cogstate composite Z score from baseline to 12 months, of oral memantine hydrochloride (memantine) administered for a period of 6 months, when compared to placebo, in children ages 4-18 receiving cranial or craniospinal radiotherapy for primary central nervous system tumors.
- I. To determine if memantine is associated with improved cognitive function as measured for participants in the optional Children's Oncology Group (COG) Standardized Battery at 12 months.
- II. To determine if memantine is associated with change in cognitive function versus (vs.#46;) placebo as measured by Cogstate composite score at end of radiation therapy (RT), 3 and 6 months.
- III. To determine if memantine is associated with differences in cognitive function vs.#46; placebo as measured by Cogstate composite score at 24 and 48 months for participants in the optional COG Standardized Battery.
- IV. To correlate early cognitive changes (end of RT, 3, 6, 12 months Cogstate composite score) with late cognitive function (24 and 48 months Cogstate composite score).
- V. To correlate COG Standardized Battery scores to Cogstate composite scores at 12, 24, and 48 months.
- VI. To estimate the 36-month disease-free and overall survival (of primary brain tumor) after memantine treatment compared to placebo.
- VII. To correlate changes in quantitative volumetric magnetic resonance imaging (MRI) measurements of critical brain regions with cognitive function over time.
- VIII. To evaluate impact of memantine versus placebo on molecular biomarkers associated with cognitive decline after radiotherapy.
- IX. To determine whether oral memantine, when compared to placebo, is associated with reduction in the incidence of decline of composite Cogstate score at 12 months in children ages 4-18 receiving cranial radiotherapy for primary central nervous system tumors.
Arms
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.
Interventions
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
Contact a Trial Team
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
Recruiting
Address
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Status
Recruiting
Address
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Status
Recruiting
Address
Banner Children's at Desert
Mesa, Arizona, 85202
Status
Recruiting
Address
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Status
Recruiting
Address
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Status
Recruiting
Address
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Status
Recruiting
Address
Kaiser Permanente Downey Medical Center
Downey, California, 90242
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
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
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
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
Status
Recruiting
Address
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
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
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Status
Recruiting
Address
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
Status
Recruiting
Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Status
Recruiting
Address
Nicklaus Children's Hospital
Miami, Florida, 33155
Status
Recruiting
Address
Miami Cancer Institute
Miami, Florida, 33176
Status
Recruiting
Address
Nemours Children's Hospital
Orlando, Florida, 32827
Status
Recruiting
Address
Tampa General Hospital
Tampa, Florida, 33606
Status
Recruiting
Address
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Status
Recruiting
Address
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Status
Recruiting
Address
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Status
Recruiting
Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Status
Recruiting
Address
University of Illinois
Chicago, Illinois, 60612
Status
Recruiting
Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Status
Recruiting
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Recruiting
Address
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
Status
Recruiting
Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Blank Children's Hospital
Des Moines, Iowa, 50309
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
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Status
Recruiting
Address
Maine Children's Cancer Program
Scarborough, Maine, 04074
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
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Status
Recruiting
Address
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Status
Recruiting
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
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
Michigan State University Clinical Center
East Lansing, Michigan, 48824
Status
Recruiting
Address
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Status
Active, not recruiting
Address
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, 48073
Status
Recruiting
Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Status
Recruiting
Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Recruiting
Address
Columbia Regional
Columbia, Missouri, 65201
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
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
Status
Recruiting
Address
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Status
Recruiting
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Recruiting
Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Status
Recruiting
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Recruiting
Address
Morristown Medical Center
Morristown, New Jersey, 07960
Status
Recruiting
Address
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Status
Recruiting
Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Status
Recruiting
Address
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Status
Recruiting
Address
Albany Medical Center
Albany, New York, 12208
Status
Recruiting
Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
Status
Recruiting
Address
Maimonides Medical Center
Brooklyn, New York, 11219
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
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Status
Suspended
Address
Mount Sinai Hospital
New York, New York, 10029
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
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
Mission Hospital
Asheville, North Carolina, 28801
Status
Recruiting
Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Status
Recruiting
Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Recruiting
Address
East Carolina University
Greenville, North Carolina, 27834
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
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
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
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Status
Recruiting
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Suspended
Address
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Status
Recruiting
Address
Geisinger Medical Center
Danville, Pennsylvania, 17822
Status
Recruiting
Address
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Status
Recruiting
Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
Rhode Island Hospital
Providence, Rhode Island, 02903
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
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Status
Recruiting
Address
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Status
Recruiting
Address
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
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
Cook Children's Medical Center
Fort Worth, Texas, 76104
Status
Recruiting
Address
M D Anderson Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Status
Recruiting
Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Status
Recruiting
Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Recruiting
Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
Status
Recruiting
Address
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Status
Recruiting
Address
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Status
Recruiting
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Status
Recruiting
Address
Carilion Children's
Roanoke, Virginia, 24014
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
Madigan Army Medical Center
Tacoma, Washington, 98431
Status
Recruiting
Address
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Status
Recruiting
Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
International Sites
Status
Suspended
Address
HIMA San Pablo Oncologic Hospital
Caguas, , 00726
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302 Ridgefield Court, Asheville, NC 28806
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