- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04939597
A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for Primary Central Nervous System Tumors
A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors
Study Overview
Status
Conditions
Detailed Description
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.
EXPLORATORY OBJECTIVES:
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.) 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. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive memantine hydrochloride orally (PO) once daily (QD) for week 1 and then twice daily (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.
ARM II: 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Caguas, Puerto Rico, 00726
- Suspended
- HIMA San Pablo Oncologic Hospital
-
-
-
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Alabama
-
Birmingham, Alabama, United States, 35233
- Recruiting
- Children's Hospital of Alabama
-
Contact:
- Site Public Contact
- Phone Number: 205-638-9285
- Email: oncologyresearch@peds.uab.edu
-
Principal Investigator:
- Girish Dhall
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
- Recruiting
- Providence Alaska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 907-212-6871
- Email: AKPAMC.OncologyResearchSupport@providence.org
-
Principal Investigator:
- Brenda J. Wittman
-
-
Arizona
-
Mesa, Arizona, United States, 85202
- Recruiting
- Banner Children's at Desert
-
Contact:
- Site Public Contact
- Phone Number: 480-412-3100
-
Principal Investigator:
- Joseph C. Torkildson
-
Phoenix, Arizona, United States, 85016
- Recruiting
- Phoenix Childrens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 602-546-0920
-
Principal Investigator:
- Lindsey M. Hoffman
-
Tucson, Arizona, United States, 85719
- Recruiting
- Banner University Medical Center - Tucson
-
Principal Investigator:
- Holly E. Pariury
-
Contact:
- Site Public Contact
- Email: UACC-IIT@uacc.arizona.edu
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202-3591
- Recruiting
- Arkansas Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 501-364-7373
-
Principal Investigator:
- David L. Becton
-
-
California
-
Downey, California, United States, 90242
- Recruiting
- Kaiser Permanente Downey Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 626-564-3455
-
Principal Investigator:
- Lisa A. Mueller
-
Loma Linda, California, United States, 92354
- Recruiting
- Loma Linda University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 909-558-4050
-
Principal Investigator:
- Albert Kheradpour
-
Long Beach, California, United States, 90806
- Recruiting
- Miller Children's and Women's Hospital Long Beach
-
Contact:
- Site Public Contact
- Phone Number: 562-933-5600
-
Principal Investigator:
- Jacqueline N. Casillas
-
Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital Los Angeles
-
Contact:
- Site Public Contact
- Phone Number: 323-361-4110
-
Principal Investigator:
- David R. Freyer
-
Madera, California, United States, 93636
- Recruiting
- Valley Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 559-353-3000
- Email: Research@valleychildrens.org
-
Principal Investigator:
- Karen S. Fernandez
-
Oakland, California, United States, 94611
- Recruiting
- Kaiser Permanente-Oakland
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Aarati V. Rao
-
Orange, California, United States, 92868
- Recruiting
- Children's Hospital of Orange County
-
Contact:
- Site Public Contact
- Phone Number: 714-509-8646
- Email: oncresearch@choc.org
-
Principal Investigator:
- Elyssa M. Rubin
-
Palo Alto, California, United States, 94304
- Recruiting
- Lucile Packard Children's Hospital Stanford University
-
Contact:
- Site Public Contact
- Phone Number: 800-694-0012
- Email: ccto-office@stanford.edu
-
Principal Investigator:
- Jay Michael S. Balagtas
-
San Diego, California, United States, 92123
- Recruiting
- Rady Children's Hospital - San Diego
-
Contact:
- Site Public Contact
- Phone Number: 858-966-5934
-
Principal Investigator:
- William D. Roberts
-
San Francisco, California, United States, 94158
- Recruiting
- UCSF Medical Center-Mission Bay
-
Contact:
- Site Public Contact
- Phone Number: 877-827-3222
- Email: cancertrials@ucsf.edu
-
Principal Investigator:
- Alyssa T. Reddy
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Site Public Contact
- Phone Number: 303-764-5056
- Email: josh.b.gordon@nsmtp.kp.org
-
Principal Investigator:
- Kathleen M. Dorris
-
Denver, Colorado, United States, 80218
- Recruiting
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 303-839-6000
-
Principal Investigator:
- Jennifer J. Clark
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Recruiting
- Connecticut Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 860-545-9981
-
Principal Investigator:
- Michael S. Isakoff
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Recruiting
- Alfred I duPont Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Scott M. Bradfield
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Recruiting
- Children's National Medical Center
-
Principal Investigator:
- Jeffrey S. Dome
-
Contact:
- Site Public Contact
- Phone Number: 202-476-2800
- Email: OncCRC_OnCall@childrensnational.org
-
-
Florida
-
Fort Myers, Florida, United States, 33908
- Recruiting
- Golisano Children's Hospital of Southwest Florida
-
Contact:
- Site Public Contact
- Phone Number: 239-343-5333
- Email: molly.arnstrom@leehealth.org
-
Principal Investigator:
- Emad K. Salman
-
Gainesville, Florida, United States, 32610
- Recruiting
- University of Florida Health Science Center - Gainesville
-
Contact:
- Site Public Contact
- Phone Number: 352-273-8010
- Email: cancer-center@ufl.edu
-
Principal Investigator:
- William B. Slayton
-
Jacksonville, Florida, United States, 32207
- Recruiting
- Nemours Children's Clinic-Jacksonville
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Scott M. Bradfield
-
Miami, Florida, United States, 33155
- Recruiting
- Nicklaus Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 888-624-2778
-
Principal Investigator:
- Ziad A. Khatib
-
Miami, Florida, United States, 33176
- Recruiting
- Miami Cancer Institute
-
Principal Investigator:
- Matthew D. Hall
-
Contact:
- Site Public Contact
- Phone Number: 786-596-2000
-
Orlando, Florida, United States, 32827
- Recruiting
- Nemours Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Scott M. Bradfield
-
Tampa, Florida, United States, 33606
- Recruiting
- Tampa General Hospital
-
Contact:
- Site Public Contact
- Phone Number: 813-844-7829
- Email: syapchanyk@tgh.org
-
Principal Investigator:
- Andrew J. Galligan
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Tampa, Florida, United States, 33607
- Recruiting
- Saint Joseph's Hospital/Children's Hospital-Tampa
-
Contact:
- Site Public Contact
- Phone Number: 813-357-0849
- Email: jennifer.manns@baycare.org
-
Principal Investigator:
- Don E. Eslin
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Recruiting
- Children's Healthcare of Atlanta - Egleston
-
Contact:
- Site Public Contact
- Phone Number: 404-785-2025
- Email: Leann.Schilling@choa.org
-
Principal Investigator:
- Tobey J. MacDonald
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96826
- Recruiting
- Kapiolani Medical Center for Women and Children
-
Contact:
- Site Public Contact
- Phone Number: 808-983-6090
-
Principal Investigator:
- Wade T. Kyono
-
-
Idaho
-
Boise, Idaho, United States, 83712
- Recruiting
- Saint Luke's Cancer Institute - Boise
-
Principal Investigator:
- Martha M. Pacheco
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 773-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
Principal Investigator:
- Wendy S. Darlington
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Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois
-
Contact:
- Site Public Contact
- Phone Number: 312-355-3046
-
Principal Investigator:
- Mary L. Schmidt
-
Maywood, Illinois, United States, 60153
- Recruiting
- Loyola University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 708-226-4357
-
Principal Investigator:
- Eugene Suh
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Peoria, Illinois, United States, 61637
- Recruiting
- Saint Jude Midwest Affiliate
-
Contact:
- Site Public Contact
- Phone Number: 888-226-4343
-
Principal Investigator:
- Prerna Kumar
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Riley Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 800-248-1199
-
Principal Investigator:
- Sandeep Batra
-
-
Iowa
-
Des Moines, Iowa, United States, 50309
- Recruiting
- Blank Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 515-241-8912
- Email: samantha.mallory@unitypoint.org
-
Principal Investigator:
- Samantha L. Mallory
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa/Holden Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-237-1225
-
Principal Investigator:
- David S. Dickens
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- Norton Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 502-629-5500
- Email: CancerResource@nortonhealthcare.org
-
Principal Investigator:
- Ashok B. Raj
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70118
- Recruiting
- Children's Hospital New Orleans
-
Contact:
- Site Public Contact
- Email: CHResearch@lcmchealth.org
-
Principal Investigator:
- Lolie C. Yu
-
New Orleans, Louisiana, United States, 70121
- Recruiting
- Ochsner Medical Center Jefferson
-
Contact:
- Site Public Contact
- Phone Number: 504-842-8084
- Email: Elisemarie.curry@ochsner.org
-
Principal Investigator:
- Craig Lotterman
-
-
Maine
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Scarborough, Maine, United States, 04074
- Recruiting
- Maine Children's Cancer Program
-
Contact:
- Site Public Contact
- Phone Number: 207-396-7581
- Email: sverwys@mmc.org
-
Principal Investigator:
- Nadav L. Kastle
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 410-955-8804
- Email: jhcccro@jhmi.edu
-
Principal Investigator:
- Kenneth J. Cohen
-
Baltimore, Maryland, United States, 21215
- Recruiting
- Sinai Hospital of Baltimore
-
Contact:
- Site Public Contact
- Phone Number: 410-601-6120
- Email: pridgely@lifebridgehealth.org
-
Principal Investigator:
- Jason M. Fixler
-
Bethesda, Maryland, United States, 20889-5600
- Recruiting
- Walter Reed National Military Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 301-319-2100
-
Principal Investigator:
- Allen I. Stering
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital Cancer Center
-
Principal Investigator:
- Mary S. Huang
-
Contact:
- Site Public Contact
- Phone Number: 877-726-5130
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 877-442-3324
-
Principal Investigator:
- Nicole J. Ullrich
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- C S Mott Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-865-1125
-
Principal Investigator:
- Andrea T. Franson
-
Detroit, Michigan, United States, 48201
- Recruiting
- Children's Hospital of Michigan
-
Principal Investigator:
- Stephanie A. Toll
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
East Lansing, Michigan, United States, 48824
- Recruiting
- Michigan State University Clinical Center
-
Contact:
- Site Public Contact
- Phone Number: 517-975-9547
-
Principal Investigator:
- Laura E. Agresta
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Grand Rapids, Michigan, United States, 49503
- Recruiting
- Helen DeVos Children's Hospital at Spectrum Health
-
Principal Investigator:
- Kathleen J. Yost
-
Contact:
- Site Public Contact
- Phone Number: 616-267-1925
- Email: crcwm-regulatory@crcwm.org
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Royal Oak, Michigan, United States, 48073
- Active, not recruiting
- Beaumont Children's Hospital-Royal Oak
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- Recruiting
- Children's Hospitals and Clinics of Minnesota - Minneapolis
-
Principal Investigator:
- Michael K. Richards
-
Contact:
- Site Public Contact
- Phone Number: 612-813-5913
- Email: pauline.mitby@childrensmn.org
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Principal Investigator:
- Nadia N. Laack
-
Contact:
- Site Public Contact
- Phone Number: 855-776-0015
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- Recruiting
- University of Mississippi Medical Center
-
Principal Investigator:
- Betty L. Herrington
-
Contact:
- Site Public Contact
- Phone Number: 601-815-6700
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Recruiting
- Columbia Regional
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
Principal Investigator:
- Barbara A. Gruner
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Hospitals and Clinics
-
Contact:
- Site Public Contact
- Phone Number: 816-302-6808
- Email: rryan@cmh.edu
-
Principal Investigator:
- Keith J. August
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Daniel Willis
-
Saint Louis, Missouri, United States, 63104
- Recruiting
- Cardinal Glennon Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 314-268-4000
-
Principal Investigator:
- William S. Ferguson
-
Saint Louis, Missouri, United States, 63141
- Recruiting
- Mercy Hospital Saint Louis
-
Contact:
- Site Public Contact
- Phone Number: 314-251-7066
-
Principal Investigator:
- Robin D. Hanson
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Children's Hospital and Medical Center of Omaha
-
Contact:
- Site Public Contact
- Phone Number: 402-955-3949
-
Principal Investigator:
- Jill C. Beck
-
Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Jill C. Beck
-
-
Nevada
-
Las Vegas, Nevada, United States, 89135
- Recruiting
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 201-996-2879
-
Principal Investigator:
- Derek R. Hanson
-
Morristown, New Jersey, United States, 07960
- Recruiting
- Morristown Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 973-971-5900
-
Principal Investigator:
- Kathryn L. Laurie
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Saint Peter's University Hospital
-
Contact:
- Site Public Contact
- Phone Number: 6163 732-745-8600
- Email: kcovert@saintpetersuh.com
-
Principal Investigator:
- Nibal A. Zaghloul
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
Contact:
- Site Public Contact
- Phone Number: 732-235-8675
-
Principal Investigator:
- Peter D. Cole
-
Paterson, New Jersey, United States, 07503
- Recruiting
- Saint Joseph's Regional Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 973-754-2207
- Email: HallL@sjhmc.org
-
Principal Investigator:
- Alissa Kahn
-
-
New York
-
Albany, New York, United States, 12208
- Recruiting
- Albany Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 518-262-5513
-
Principal Investigator:
- Lauren R. Weintraub
-
Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center - Moses Campus
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Principal Investigator:
- Alice Lee
-
Brooklyn, New York, United States, 11219
- Recruiting
- Maimonides Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 718-765-2500
-
Principal Investigator:
- Mahmut Y. Celiker
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 800-767-9355
- Email: askroswell@roswellpark.org
-
Principal Investigator:
- Clare J. Twist
-
New Hyde Park, New York, United States, 11040
- Recruiting
- The Steven and Alexandra Cohen Children's Medical Center of New York
-
Contact:
- Site Public Contact
- Phone Number: 718-470-3460
-
Principal Investigator:
- Mark P. Atlas
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Principal Investigator:
- Sameer Farouk Sait
-
New York, New York, United States, 10016
- Recruiting
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Contact:
- Site Public Contact
- Email: CancerTrials@nyulangone.org
-
Principal Investigator:
- Sharon L. Gardner
-
New York, New York, United States, 10029
- Suspended
- Mount Sinai Hospital
-
Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-862-2215
-
Principal Investigator:
- Laura E. Hogan
-
Syracuse, New York, United States, 13210
- Recruiting
- State University of New York Upstate Medical University
-
Contact:
- Site Public Contact
- Phone Number: 315-464-5476
-
Principal Investigator:
- Philip M. Monteleone
-
-
North Carolina
-
Asheville, North Carolina, United States, 28801
- Recruiting
- Mission Hospital
-
Contact:
- Site Public Contact
- Phone Number: 828-213-7055
- Email: NCDV.ResearchRegulatory@HCAHealthcare.com
-
Principal Investigator:
- Douglas J. Scothorn
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- UNC Lineberger Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-668-0683
- Email: cancerclinicaltrials@med.unc.edu
-
Principal Investigator:
- David E. Kram
-
Charlotte, North Carolina, United States, 28203
- Recruiting
- Carolinas Medical Center/Levine Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 800-804-9376
-
Principal Investigator:
- Joel A. Kaplan
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Medical Center
-
Principal Investigator:
- Jessica M. Sun
-
Contact:
- Site Public Contact
- Phone Number: 888-275-3853
-
Greenville, North Carolina, United States, 27834
- Recruiting
- East Carolina University
-
Contact:
- Site Public Contact
- Phone Number: 252-744-1015
- Email: eubankss@ecu.edu
-
Principal Investigator:
- Andrea R. Whitfield
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Site Public Contact
- Phone Number: 336-713-6771
-
Principal Investigator:
- Thomas W. McLean
-
-
North Dakota
-
Fargo, North Dakota, United States, 58122
- Recruiting
- Sanford Broadway Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 701-323-5760
- Email: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Principal Investigator:
- Samuel J. Milanovich
-
-
Ohio
-
Akron, Ohio, United States, 44308
- Recruiting
- Children's Hospital Medical Center of Akron
-
Contact:
- Site Public Contact
- Phone Number: 330-543-3193
-
Principal Investigator:
- Erin Wright
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 513-636-2799
- Email: cancer@cchmc.org
-
Principal Investigator:
- Peter M. de Blank
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Principal Investigator:
- Rabi Hanna
-
Cleveland, Ohio, United States, 44106
- Recruiting
- Rainbow Babies and Childrens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 216-844-5437
-
Principal Investigator:
- Duncan S. Stearns
-
Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 614-722-6039
- Email: Melinda.Triplet@nationwidechildrens.org
-
Principal Investigator:
- Mark A. Ranalli
-
Dayton, Ohio, United States, 45404
- Recruiting
- Dayton Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-228-4055
-
Principal Investigator:
- Mukund G. Dole
-
Toledo, Ohio, United States, 43606
- Recruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 419-824-1842
- Email: PCIOncResearch@promedica.org
-
Principal Investigator:
- Jamie L. Dargart
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Rene Y. McNall-Knapp
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Recruiting
- Legacy Emanuel Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 503-413-2560
-
Principal Investigator:
- Janice F. Olson
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
-
Contact:
- Site Public Contact
- Phone Number: 503-494-1080
- Email: trials@ohsu.edu
-
Principal Investigator:
- Linda C. Stork
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- Suspended
- Lehigh Valley Hospital-Cedar Crest
-
Danville, Pennsylvania, United States, 17822
- Recruiting
- Geisinger Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 570-271-5251
- Email: HemonCCTrials@geisinger.edu
-
Principal Investigator:
- Jagadeesh Ramdas
-
Philadelphia, Pennsylvania, United States, 19134
- Recruiting
- Saint Christopher's Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 215-427-8991
-
Principal Investigator:
- Gregory E. Halligan
-
Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- Children's Hospital of Pittsburgh of UPMC
-
Contact:
- Site Public Contact
- Phone Number: 412-692-8570
- Email: jean.tersak@chp.edu
-
Principal Investigator:
- James T. Felker
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
-
Contact:
- Site Public Contact
- Phone Number: 401-444-1488
-
Principal Investigator:
- Jennifer J. Welch
-
-
South Carolina
-
Columbia, South Carolina, United States, 29203
- Recruiting
- Prisma Health Richland Hospital
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Stuart L. Cramer
-
Greenville, South Carolina, United States, 29605
- Recruiting
- BI-LO Charities Children's Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Aniket Saha
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57117-5134
- Recruiting
- Sanford USD Medical Center - Sioux Falls
-
Contact:
- Site Public Contact
- Phone Number: 605-312-3320
- Email: OncologyClinicalTrialsSF@SanfordHealth.org
-
Principal Investigator:
- Kayelyn J. Wagner
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37916
- Recruiting
- East Tennessee Childrens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 865-541-8266
-
Principal Investigator:
- Susan E. Spiller
-
Memphis, Tennessee, United States, 38105
- Recruiting
- Saint Jude Children's Research Hospital
-
Contact:
- Site Public Contact
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
-
Principal Investigator:
- Kelsey Bertrand
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University/Ingram Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-811-8480
-
Principal Investigator:
- Adam J. Esbenshade
-
Nashville, Tennessee, United States, 37203
- Recruiting
- The Children's Hospital at TriStar Centennial
-
Contact:
- Site Public Contact
- Phone Number: 615-342-1919
-
Principal Investigator:
- Jennifer A. Domm
-
-
Texas
-
Austin, Texas, United States, 78723
- Recruiting
- Dell Children's Medical Center of Central Texas
-
Contact:
- Site Public Contact
- Phone Number: 512-628-1902
- Email: TXAUS-DL-SFCHemonc.research@ascension.org
-
Principal Investigator:
- Shannon M. Cohn
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern/Simmons Cancer Center-Dallas
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Principal Investigator:
- Daniel C. Bowers
-
Dallas, Texas, United States, 75230
- Recruiting
- Medical City Dallas Hospital
-
Contact:
- Site Public Contact
- Phone Number: 972-566-5588
-
Principal Investigator:
- Stanton C. Goldman
-
El Paso, Texas, United States, 79905
- Recruiting
- El Paso Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 915-298-5444
- Email: ranjan.bista@ttuhsc.edu
-
Principal Investigator:
- Benjamin Carcamo
-
Fort Worth, Texas, United States, 76104
- Recruiting
- Cook Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 682-885-2103
- Email: CookChildrensResearch@cookchildrens.org
-
Principal Investigator:
- Sibo Zhao
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-632-6789
- Email: askmdanderson@mdanderson.org
-
Principal Investigator:
- Najat C. Daw
-
San Antonio, Texas, United States, 78207
- Recruiting
- Children's Hospital of San Antonio
-
Contact:
- Site Public Contact
- Phone Number: 210-704-2894
- Email: bridget.medina@christushealth.org
-
Principal Investigator:
- Timothy C. Griffin
-
San Antonio, Texas, United States, 78229
- Recruiting
- University of Texas Health Science Center at San Antonio
-
Contact:
- Site Public Contact
- Phone Number: 210-450-3800
- Email: phoresearchoffice@uthscsa.edu
-
Principal Investigator:
- Anne-Marie R. Langevin
-
San Antonio, Texas, United States, 78229
- Recruiting
- Methodist Children's Hospital of South Texas
-
Contact:
- Site Public Contact
- Phone Number: 210-575-6240
- Email: Vinod.GidvaniDiaz@hcahealthcare.com
-
Principal Investigator:
- Jose M. Esquilin
-
-
Utah
-
Salt Lake City, Utah, United States, 84113
- Recruiting
- Primary Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 801-585-5270
-
Principal Investigator:
- Priya Chan
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 434-243-6303
- Email: uvacancertrials@hscmail.mcc.virginia.edu
-
Principal Investigator:
- William C. Petersen
-
Norfolk, Virginia, United States, 23507
- Recruiting
- Children's Hospital of The King's Daughters
-
Contact:
- Site Public Contact
- Phone Number: 757-668-7243
- Email: CCBDCresearch@chkd.org
-
Principal Investigator:
- Eric J. Lowe
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University/Massey Cancer Center
-
Contact:
- Site Public Contact
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Timothy J. Harris
-
Roanoke, Virginia, United States, 24014
- Recruiting
- Carilion Children's
-
Contact:
- Site Public Contact
- Phone Number: 540-266-6238
- Email: wpmccarty@carilionclinic.org
-
Principal Investigator:
- Erwood G. Edwards
-
-
Washington
-
Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 866-987-2000
-
Principal Investigator:
- Sarah E. Leary
-
Spokane, Washington, United States, 99204
- Recruiting
- Providence Sacred Heart Medical Center and Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-228-6618
- Email: HopeBeginsHere@providence.org
-
Principal Investigator:
- Judy L. Felgenhauer
-
Tacoma, Washington, United States, 98405
- Recruiting
- Mary Bridge Children's Hospital and Health Center
-
Contact:
- Site Public Contact
- Phone Number: 253-403-1461
- Email: research@multicare.org
-
Principal Investigator:
- Robert G. Irwin
-
Tacoma, Washington, United States, 98431
- Recruiting
- Madigan Army Medical Center
-
Principal Investigator:
- Melissa A. Forouhar
-
Contact:
- Site Public Contact
- Phone Number: 253-968-6144
- Email: melissa.a.forouhar.mil@health.mil
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- Recruiting
- West Virginia University Healthcare
-
Contact:
- Site Public Contact
- Phone Number: 304-293-7374
- Email: cancertrialsinfo@hsc.wvu.edu
-
Principal Investigator:
- Ashley E. Meyer
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin Carbone Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-622-8922
-
Principal Investigator:
- Kenneth B. De Santes
-
Marshfield, Wisconsin, United States, 54449
- Recruiting
- Marshfield Medical Center-Marshfield
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Jon M. Brandt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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. A pregnancy test is required for female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who do not agree to use an effective contraceptive method for the duration of their study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Ancillary studies
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Complete cognitive testing
|
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.
|
Ancillary studies
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Complete cognitive testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The mean slope of the Cogstate composite Z score (an average of detection, Identification, and one-back Z scores, each Z score calculated using Cogstate age-based normative data)
Time Frame: Up-to 12 months post baseline
|
We will estimate the difference in mean Cogstate composite Z score slopes (reflecting change in Cogstate composite Z scores from baseline to 12 months post baseline taking into account measurements at those time points as well as end of radiation therapy and 3 and 6-months post baseline between the treatment and control arms using a generalized estimating equation model with compound symmetry correlation structure and will provide a point estimate and corresponding 95% confidence interval.
|
Up-to 12 months post baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intelligence quotient score (assessed by age-appropriate Wechsler Intelligence Scale)
Time Frame: At 12-months post baseline
|
We will estimate the difference in mean standard scores across treatment arms and will provide a point estimate and corresponding 95% confidence interval.
|
At 12-months post baseline
|
Processing speed score (assessed by processing speed/attention subtests of age-appropriate Wechsler Intelligence Scale)
Time Frame: At 12-months post baseline
|
We will estimate the difference in mean standard scores and will provide a point estimate and corresponding 95% confidence interval.
|
At 12-months post baseline
|
Verbal memory score (assessed by Children's Memory Scale [CMS] Stories subtest, or the Wechsler Memory Scale - Fourth Edition [WMS-IV] Logical Memory I and II subtests, depending on age)
Time Frame: At 12-months post baseline
|
We will estimate the difference in mean standard scores across treatment arms and will provide a point estimate and corresponding 95% confidence interval.
|
At 12-months post baseline
|
Visual memory score (assessed by CMS or WMS-IV Faces subtest scores, Immediate and Delayed, depending on age)
Time Frame: At 12-months post baseline
|
We will estimate the difference in mean standard scores across treatment arms and will provide a point estimate and corresponding 95% confidence interval.
|
At 12-months post baseline
|
Working memory score (assessed by Digit Span subtests of age-appropriate Wechsler Intelligence Scales)
Time Frame: At 12-months post baseline
|
We will estimate the difference in mean standard scores across treatment arms and will provide a point estimate and corresponding 95% confidence interval.
|
At 12-months post baseline
|
Verbal score (assessed by the California Verbal Learning Test - Children's Version [CVLT-C] or 2nd Edition [CVLT-II] based on age, using the List A Trials 1-5 Total T-score)
Time Frame: At 12-months post baseline
|
We will estimate the difference in mean standard scores and will provide a point estimate and corresponding 95% confidence interval.
|
At 12-months post baseline
|
Visual learning score (assessed by CMS Dot Locations subtest or WMS-IV Symbol Span subtest, depending on age)
Time Frame: At 12-months post baseline
|
We will estimate the difference in mean standard scores across treatment arms and will provide a point estimate and corresponding 95% confidence interval.
|
At 12-months post baseline
|
Executive functioning score (assessed by the Cognitive Regulation Index of the Brief Rating Inventory of Executive Function)
Time Frame: At 12-months post baseline
|
We will estimate the difference in mean standard scores across treatment arms and will provide a point estimate and corresponding 95% confidence interval.
|
At 12-months post baseline
|
Disease-free survival
Time Frame: Up-to 36 months post baseline
|
We will estimate the hazard ratio comparing time-to-relapse of primary brain tumor or death due to any cause in the memantine relative to placebo arm and will provide a point estimate and corresponding 95% confidence interval.
|
Up-to 36 months post baseline
|
Overall survival
Time Frame: Up-to 36 months post baseline
|
We will estimate the hazard ratio comparing time-to- death due to any cause in the memantine relative to placebo arm and will provide a point estimate and corresponding 95% confidence interval.
|
Up-to 36 months post baseline
|
Quantitative volumetric magnetic resonance imaging (MRI) measurements of critical brain regions (hippocampus, frontal cortex)
Time Frame: At 12-months post baseline
|
We will estimate a correlation coefficient between changes in quantitative volumetric MRI measurements for the three regions of interest and changes in Cogstate composite Z scores (from baseline to 12 months post baseline).
|
At 12-months post baseline
|
Number of patients who consented to biobanking
Time Frame: Up-to 12 months post baseline
|
The number of patients who agree to be in the biobanking part of the study future research.
|
Up-to 12 months post baseline
|
Composite cognitive score decline (0.5 standard deviation or more decline in Cogstate composite score relative to baseline)
Time Frame: At 12-months post baseline
|
We will estimate the proportion of patients who experience composite cognitive score decline in the memantine and placebo arms and will provide corresponding 95% confidence intervals.
|
At 12-months post baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nadia N Laack, Children's Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- ACCL2031 (Other Identifier: CTEP)
- UG1CA189955 (U.S. NIH Grant/Contract)
- U24CA196173 (U.S. NIH Grant/Contract)
- NCI-2020-07502 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- COG-ACCL2031 (Other Identifier: DCP)
- U01CA246568 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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