Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors

PHASE3CompletedINTERVENTIONAL
Enrollment

554

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

April 30, 2011

Study Completion Date

December 31, 2016

Conditions
Cognitive/Functional EffectsMetastatic CancerNeurotoxicityUnspecified Adult Solid Tumor, Protocol Specific
Interventions
DRUG

Memantine

Patients began taking memantine(by mouth) while receiving radiation therapy. Patients continued taking memantine for 24 weeks or until doctor thinks it is in their best interest to stop. They started with 5 mg once a day. After a week dose increased to 5 mg twice a day. At week 3, dose increased to 10 mg in the morning and 5 mg in the evening. Weeks 4-24, dose was 10 mg twice a day.

OTHER

Placebo

Patients began taking placebo(by mouth) while receiving radiation therapy. Patients continued taking placebo for 24 weeks or until doctor thinks it is in their best interest to stop. They started with 5 mg once a day. After a week dose increased to 5 mg twice a day. At week 3, dose increased to 10 mg in the morning and 5 mg in the evening. Weeks 4-24, dose was 10 mg twice a day.

RADIATION

Whole brain radiation therapy

Whole brain radiation therapy (WBRT) once a day (2.5Gy), five days a week (Monday to Friday) for three weeks, for total fifteen treatments and 37.5 Gy

Trial Locations (235)

11030

CCOP - North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

11215

New York Methodist Hospital, Brooklyn

12206

New York Oncology Hematology, PC at Albany Regional Cancer Care, Albany

12208

Veterans Affairs Medical Center - Albany, Albany

14424

Sands Cancer Center, Canandaigua

14620

Highland Hospital of Rochester, Rochester

14621

Lipson Cancer and Blood Center at Rochester General Hospital, Rochester

14626

University Radiation Oncology at Parkridge Hospital, Rochester

14642

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester

15009

UPMC Cancer Center at Beaver Medical Center, Beaver

15025

UPMC Cancer Center at Jefferson Regional Medical Center, Clairton

15065

UPMC Cancer Center - Natrona Heights, Natrona Heights

15108

UPMC - Moon, Moon Township

15132

UPMC Cancer Center at UPMC McKeesport, McKeesport

15213

UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh

15215

UPMC Cancer Center at UPMC St. Margaret, Pittsburgh

15237

UPMC Cancer Center at UPMC Passavant, Pittsburgh

15243

UPMC Cancer Center - Upper St. Clair, Pittsburgh

15301

Washington Hospital Cancer Center, Washington

15401

UPMC Cancer Center - Uniontown, Uniontown

15601

UPMC Cancer Center - Arnold Palmer Pavilion, Greensburg

15901

UPMC Cancer Center at the John P. Murtha Pavilion, Johnstown

16105

Jameson Memorial Hospital - North Campus, New Castle

16214

Cancer Center at Clarion Hospital, Clarion

16346

UPMC Cancer Center at UPMC Northwest, Seneca

17325

Adams Cancer Center, Gettysburg

17331

Cherry Tree Cancer Center, Hanover

17405

York Cancer Center at Apple Hill Medical Center, York

18015

St. Luke's Cancer Network at St. Luke's Hospital, Bethlehem

18512

Northeast Radiation Oncology Center, Dunmore

19001

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington

19010

Bryn Mawr Hospital, Bryn Mawr

19026

Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill

19096

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

19141

Albert Einstein Cancer Center, Philadelphia

19713

CCOP - Christiana Care Health Services, Newark

20010

Washington Cancer Institute at Washington Hospital Center, Washington D.C.

21044

Central Maryland Oncology Center, Columbia

21061

Tate Cancer Center at Baltimore Washington Medical Center, Glen Burnie

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

21204

Cancer Institute at St. Joseph Medical Center, Towson

21229

St. Agnes Hospital Cancer Center, Baltimore

21237

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center, Baltimore

21239

Good Samaritan Hospital of Maryland, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

23507

Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk

26003

Schiffler Cancer Center at Wheeling Hospital, Wheeling

28401

New Hanover Radiation Oncology, PA, Wilmington

28801

Mission Hospitals - Memorial Campus, Asheville

29303

CCOP - Upstate Carolina, Spartanburg

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

30033

Veterans Affairs Medical Center - Atlanta (Decatur), Decatur

30322

Winship Cancer Institute of Emory University, Atlanta

30501

Northeast Georgia Medical Center, Gainesville

31904

John B. Amos Cancer Center, Columbus

32073

Integrated Community Oncology Network - Orange Park, Orange Park

32086

Flagler Cancer Center, Saint Augustine

32177

Florida Cancer Center - Palatka, Palatka

32207

Baptist Cancer Institute - Jacksonville, Jacksonville

Integrated Community Oncology Network at Southside Cancer Center, Jacksonville

32250

Integrated Community Oncology Network, Jacksonville Beach

32258

Baptist Medical Center South, Jacksonville

32806

Florida Institute of Research, Medicine and Surgery Cancer Center, Orlando

36604

MBCCOP - Gulf Coast, Mobile

36608

Providence Cancer Center at Providence Hospital, Mobile

39581

Regional Cancer Center at Singing River Hospital, Pascagoula

40207

Norton Suburban Hospital, Louisville

43560

Flower Hospital Cancer Center, Sylvania

43614

Medical University of Ohio Cancer Center, Toledo

43616

St. Charles Mercy Hospital, Oregon

43617

CCOP - Toledo Community Hospital, Toledo

43623

St. Anne Mercy Hospital, Toledo

44111

Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland

44124

Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights

44131

Cleveland Clinic Cancer Center, Independence

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

44203

Barberton Citizens Hospital, Barberton

44307

McDowell Cancer Center at Akron General Medical Center, Akron

44460

Cancer Care Center, Incorporated, Salem

44691

Cancer Treatment Center, Wooster

Cleveland Clinic - Wooster, Wooster

44870

North Coast Cancer Care, Incorporated, Sandusky

45069

Precision Radiotherapy at University Pointe, West Chester

45267

Charles M. Barrett Cancer Center at University Hospital, Cincinnati

46016

Saint John's Cancer Center at Saint John's Medical Center, Anderson

46202

Methodist Cancer Center at Methodist Hospital, Indianapolis

46219

Central Indiana Cancer Centers - East, Indianapolis

Community Regional Cancer Care at Community Hospital East, Indianapolis

46256

Community Regional Cancer Care at Community Hospital North, Indianapolis

46526

Center for Cancer Care at Goshen General Hospital, Goshen

46601

CCOP - Northern Indiana CR Consortium, South Bend

46804

Radiation Oncology Associates Southwest, Fort Wayne

46805

Parkview Regional Cancer Center at Parkview Health, Fort Wayne

47403

Bloomington Hospital Regional Cancer Institute, Bloomington

48073

William Beaumont Hospital - Royal Oak Campus, Royal Oak

48154

St. Mary Mercy Hospital, Livonia

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

48382

Charach Cancer Center at Huron Valley - Sinai Hospital, Commerce

48532

Great Lakes Cancer Institute at McLaren Regional Medical Center, Flint

49503

CCOP - Grand Rapids, Grand Rapids

53051

Community Memorial Hospital Cancer Care Center, Menomonee Falls

53215

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center, Milwaukee

53226

Medical College of Wisconsin Cancer Center, Milwaukee

53227

West Allis Memorial Hospital, West Allis

53405

All Saints Cancer Center at Wheaton Franciscan Healthcare, Racine

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54401

University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau

54601

Franciscan Skemp Healthcare - La Crosse Campus, La Crosse

54911

Theda Care Cancer Institute, Appleton

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology, PA - Maplewood, Maplewood

55337

Fairview Ridges Hospital, Burnsville

55387

Ridgeview Medical Center, Waconia

55407

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis

55416

CCOP - Metro-Minnesota, Saint Louis Park

55432

Mercy and Unity Cancer Center at Unity Hospital, Fridley

55433

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55905

Mayo Clinic Cancer Center, Rochester

56002

Immanuel St. Joseph's, Mankato

56007

Albert Lea Cancer Center at Albert Lea Medical Center, Albert Lea

56303

CentraCare Clinic - River Campus, Saint Cloud

57701

Rapid City Regional Hospital, Rapid City

58701

Trinity CancerCare Center, Minot

59101

CCOP - Montana Cancer Consortium, Billings

Northern Rockies Radiation Oncology Center, Billings

60005

Northwest Community Hospital, Arlington Heights

61801

CCOP - Carle Cancer Center, Urbana

62702

Cancer Institute at St. John's Hospital, Springfield

63141

CCOP - St. Louis-Cape Girardeau, St Louis

64131

Kansas City Cancer Centers - South, Kansas City

64154

Kansas City Cancer Centers - North, Kansas City

65807

Hulston Cancer Center at Cox Medical Center South, Springfield

66210

Kansas City Cancer Centers - Southwest, Overland Park

68114

Methodist Estabrook Cancer Center, Omaha

68198

Nebraska Medical Center, Omaha

73104

Oklahoma University Cancer Institute, Oklahoma City

75090

Texas Oncology, PA at Texas Cancer Center - Sherman, Sherman

75230

Medical City Dallas Hospital, Dallas

75237

Texas Oncology, PA at Texas Cancer Center Dallas Southwest, Dallas

75390

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas

75601

Longview Cancer Center, Longview

75702

Tyler Cancer Center, Tyler

76014

Texas Oncology, PA at Texas Cancer Center - Arlington South, Arlington

76022

Texas Oncology, PA at Harris Center HEB, Bedford

76104

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital, Fort Worth

76210

Texas Oncology, PA at Texas Cancer Center - Denton South, Denton

77479

Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land, Sugar Land

78217

Cancer Care Centers of South Texas - Northeast, San Antonio

79761

West Texas Cancer Center, Odessa

80012

Rocky Mountain Cancer Centers - Aurora, Aurora

80528

Poudre Valley Radiation Oncology, Fort Collins

80909

Rocky Mountain Cancer Centers - Colorado Springs, Colorado Springs

84106

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

84157

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray

84403

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden

84770

Dixie Regional Medical Center - East Campus, St. George

85013

Arizona Oncology Services Foundation, Phoenix

85704

Arizona Oncology - Tucson, Tucson

87102

Lovelace Medical Center - Downtown, Albuquerque

87109

Radiation Oncology Associates, PA, Albuquerque

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

89502

Renown Institute for Cancer at Renown Regional Medical Center, Reno

90048

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles

91206

Glendale Adventist Medical Center, Glendale

91505

Providence Saint Joseph Medical Center - Burbank, Burbank

92868

St. Joseph Hospital Regional Cancer Center - Orange, Orange

94598

John Muir/Mt. Diablo Comprehensive Cancer Center, Walnut Creek

95382

Emanuel Regional Cancer Services at Emanuel Medical Center, Turlock

95603

Auburn Radiation Oncology, Auburn

95608

Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael

95661

Radiation Oncology Center - Roseville, Roseville

95682

Radiation Oncology Centers - Cameron Park, Cameron Park

95687

Solano Radiation Oncology Center, Vacaville

95815

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento

95817

University of California Davis Cancer Center, Sacramento

95819

Mercy General Hospital, Sacramento

95926

Enloe Cancer Center at Enloe Medical Center, Chico

97401

Willamette Valley Cancer Center - Eugene, Eugene

97504

Dubs Cancer Center at Rogue Valley Medical Center, Medford

Providence Cancer Center at PMCC, Medford

97527

Three Rivers Community Hospital, Grants Pass

98101

CCOP - Virginia Mason Research Center, Seattle

98902

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima

99202

Cancer Care Northwest - Spokane South, Spokane

85259-5499

Mayo Clinic Scottsdale, Scottsdale

85724-5024

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson

94524-4110

Cancer Care Center at John Muir Health - Concord Campus, Concord

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

92093-0658

Rebecca and John Moores UCSD Cancer Center, La Jolla

90089-9181

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

94305-5824

Stanford Cancer Center, Stanford

06520-8028

Yale Cancer Center, New Haven

32610-0232

University of Florida Shands Cancer Center, Gainesville

60612-3785

John H. Stroger, Jr. Hospital of Cook County, Chicago

46202-5289

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

47303-3499

Cancer Center at Ball Memorial Hospital, Muncie

52242-1002

Holden Comprehensive Cancer Center at University of Iowa, Iowa City

40536-0093

Lucille P. Markey Cancer Center at University of Kentucky, Lexington

02118

Boston University Cancer Research Center, Boston

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

55422-2900

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale

59107-7000

Billings Clinic - Downtown, Billings

03301

Payson Center for Cancer Care at Concord Hospital, Concord

03103

Elliot Regional Cancer Center at Elliot Hospital, Manchester

08103

Cancer Institute of New Jersey at Cooper University Hospital - Camden, Camden

07207

Trinitas Comprehensive Cancer Center at Trinitas Hospital, Elizabeth

08831

Princeton Radiation Oncology Center, Jamesburg

08724

Ocean Medical Center at Meridian Health, Laurelton

08901

Saint Peter's University Hospital, New Brunswick

08540-3298

University Medical Center at Princeton, Princeton

08755

J. Phillip Citta Regional Cancer Center at Community Medical Center, Toms River

08043

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees Township

87131-5636

University of New Mexico Cancer Center, Albuquerque

14263-0001

Roswell Park Cancer Institute, Buffalo

44309-2090

Summa Center for Cancer Care at Akron City Hospital, Akron

43210-1240

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus

43537-1839

Northwest Ohio Oncology Center, Maumee

17822-0001

Geisinger Cancer Institute at Geisinger Health, Danville

17033-0850

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey

19107-5541

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

19111-2497

Fox Chase Cancer Center - Philadelphia, Philadelphia

15213-2582

UPMC - Shadyside, Pittsburgh

78229-3900

University of Texas Health Science Center at San Antonio, San Antonio

05401

Fletcher Allen Health Care - University Health Center Campus, Burlington

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

53792-6164

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison

B3H 1V8

Nova Scotia Cancer Centre, Halifax

N6A 4L6

London Regional Cancer Program at London Health Sciences Centre, London

H1T 2M4

Maisonneuve-Rosemont Hospital, Montreal

H2L 4M1

Hopital Notre-Dame du CHUM, Montreal

H2W 1S6

McGill Cancer Centre at McGill University, Montreal

G1R 2J6

Centre Hospitalier Universitaire de Quebec, Québec

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK

NCT00566852 - Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors | Biotech Hunter | Biotech Hunter