Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

PHASE2CompletedINTERVENTIONAL
Enrollment

378

Participants

Timeline

Start Date

August 31, 2003

Primary Completion Date

January 1, 2010

Study Completion Date

March 31, 2016

Conditions
Brain TumorCentral Nervous System Tumor
Interventions
BIOLOGICAL

filgrastim

Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously.

DRUG

carboplatin

Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patients with BSA \<0.45m2 the dose is 12.5 mg/kg/day.

DRUG

cyclophosphamide

Given IV (1000mg/m2/day) Day 1 and 2 given as an IV infusion over one hour following carboplatin administration. For patients with BSA\<0.45m2 the dose is 33mg/kg/day on Day 1 and 2.

DRUG

etoposide

Given orally (50 mg/m2/day) orally once daily on Days 1 through 21. For patients with BSA \< 0.45 m2, the dosage is 1.7 mg/kg/day on Days 1 through 21.

DRUG

vincristine sulfate

Given IV or orally (1.5mg/m2/day) (maximum dose 2 mg) Day 1 and 8 given as IV bolus. For patients with BSA\<0.45m2 the dose is 0.05mg/kg.

RADIATION

radiation therapy

Given once daily 5 days a week for 6-6½ weeks

DRUG

Mesna

Mesna (200mg/m2/dose) Day 1 and 2. For patients with BSA\<0.45m2 the dose is (7mg/kg/dose). Combine mesna (200mg/m2) with cyclophosphamide and administer intravenously over one hour followed by mesna (200mg/m2) in 375 cc/m2 D5-1/2NS and run intravenously over 3 hours at 125cc/m2/hr. After 3 hour mesna, administer mesna (200 mg/m2/dose) IV over 15 minutes at hour 5.

PROCEDURE

therapeutic conventional surgery

Trial Locations (165)

1

Starship Children's Health, Auckland

1011

Swiss Pediatric Oncology Group Lausanne, Lausanne

1205

Swiss Pediatric Oncology Group Geneva, Geneva

2031

Prince of Wales Private Hospital, Randwick

2145

Westmead Institute for Cancer Research at Westmead Hospital, Westmead

2310

John Hunter Hospital, Newcastle

3010

Swiss Pediatric Oncology Group Bern, Bern

3052

Royal Children's Hospital, Parkville

4029

Royal Children's Hospital, Herston, Brisbane

5006

Women's and Children's Hospital, North Adelaide

6001

Princess Margaret Hospital for Children, Perth

10016

NYU Cancer Institute at New York University Medical Center, New York

10032

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York

10461

Albert Einstein Cancer Center at Albert Einstein College of Medicine, The Bronx

10595

New York Medical College, Valhalla

11040

Schneider Children's Hospital, New Hyde Park

13210

SUNY Upstate Medical University Hospital, Syracuse

14642

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

15213

Children's Hospital of Pittsburgh, Pittsburgh

19803

Alfred I. duPont Hospital for Children, Wilmington

24029

Carilion Cancer Center of Western Virginia, Roanoke

25302

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston

25701

Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington

27710

Duke Comprehensive Cancer Center, Durham

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

29605

Greenville Hospital System Cancer Center, Greenville

30322

Winship Cancer Institute of Emory University, Atlanta

32207

Nemours Children's Clinic, Jacksonville

32504

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola

32806

Nemours Children's Clinic - Orlando, Orlando

33155

Miami Children's Hospital, Miami

33407

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach

33607

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa

33701

All Children's Hospital, St. Petersburg

33901

Lee Cancer Care of Lee Memorial Health System, Fort Myers

35294

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham

37403

T.C. Thompson Children's Hospital, Chattanooga

37901

East Tennessee Children's Hospital, Knoxville

38105

St. Jude Children's Research Hospital, Memphis

40232

Kosair Children's Hospital, Louisville

43606

Toledo Hospital, Toledo

43614

Medical University of Ohio Cancer Center, Toledo

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

44501

Tod Children's Hospital, Youngstown

46260

St. Vincent Indianapolis Hospital, Indianapolis

48236

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods

48503

Hurley Medical Center, Flint

48910

Breslin Cancer Center at Ingham Regional Medical Center, Lansing

50309

Blank Children's Hospital, Des Moines

53226

Midwest Children's Cancer Center, Milwaukee

54449

Marshfield Clinic - Marshfield Center, Marshfield

55404

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis

55455

University of Minnesota Cancer Center at University of Minnesota, Minneapolis

55905

Mayo Clinic Cancer Center, Rochester

58122

CCOP - MeritCare Hospital, Fargo

60153

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood

60453

Advocate Christ Medical Center, Oak Lawn

60612

Rush University Medical Center, Chicago

60614

Children's Memorial Hospital - Chicago, Chicago

61637

Saint Jude Midwest Affiliate, Peoria

63104

Cardinal Glennon Children's Hospital, St Louis

63110

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis

64108

Children's Mercy Hospital, Kansas City

72205

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock

73104

Oklahoma University Cancer Institute, Oklahoma City

75230

Medical City Dallas Hospital, Dallas

75390

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

76104

Cook Children's Medical Center - Fort Worth, Fort Worth

76508

CCOP - Scott and White Hospital, Temple

78411

Driscoll Children's Hospital, Corpus Christi

78701

Children's Hospital of Austin, Austin

79106

Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo

79410

Covenant Children's Hospital, Lubbock

90027

Childrens Hospital Los Angeles, Los Angeles

90801

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach

92354

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

94115

UCSF Comprehensive Cancer Center, San Francisco

94305

Stanford Comprehensive Cancer Center - Stanford, Stanford

94609

Children's Hospital & Research Center Oakland, Oakland

95816

Sutter Cancer Center, Sacramento

95817

University of California Davis Cancer Center, Sacramento

95825

Kaiser Permanente Medical Center - Oakland, Sacramento

96813

Cancer Research Center of Hawaii, Honolulu

97227

Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland

98105

Children's Hospital and Regional Medical Center - Seattle, Seattle

85016-7710

Phoenix Children's Hospital, Phoenix

90242-2814

Southern California Permanente Medical Group, Downey

90048-1865

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

93638-8762

Children's Hospital Central California, Madera

92123-4282

Children's Hospital and Health Center - San Diego, San Diego

80218-1088

Children's Hospital Cancer Center, Denver

06360-2875

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington

20010-2970

Children's National Medical Center, Washington D.C.

32610-0232

University of Florida Shands Cancer Center, Gainesville

32803-1273

Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando

30912-3730

MBCCOP - Medical College of Georgia Cancer Center, Augusta

83712-6297

St. Luke's Mountain States Tumor Institute - Boise, Boise

60637-1470

University of Chicago Cancer Research Center, Chicago

60068-1174

Advocate Lutheran General Cancer Care Center, Park Ridge

62794-9620

Southern Illinois University School of Medicine, Springfield

40536-0293

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington

04401

CancerCare of Maine at Eastern Maine Medial Center, Bangor

04074-9308

Maine Children's Cancer Program at Barbara Bush Children's Hospital, Scarborough

21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

02111

Floating Hospital for Children at Tufts - New England Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston

48109-0286

C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

49503-2560

Spectrum Health Hospital - Butterworth Campus, Grand Rapids

49007-5341

CCOP - Kalamazoo, Kalamazoo

39216-4505

University of Mississippi Cancer Clinic, Jackson

68114-4113

Children's Hospital, Omaha

89109-2306

Sunrise Hospital and Medical Center, Las Vegas

07601

Hackensack University Medical Center Cancer Center, Hackensack

07962

Overlook Hospital, Morristown

08901

Saint Peter's University Hospital, New Brunswick

08903

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick

07503

St. Joseph's Hospital and Medical Center, Paterson

87131-5636

University of New Mexico Cancer Research and Treatment Center, Albuquerque

12208-3419

Albany Medical Center Hospital, Albany

14263-0001

Roswell Park Cancer Institute, Buffalo

10021-6094

Memorial Sloan - Kettering Cancer Center, New York

28232-2861

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

27157-1096

Wake Forest University Comprehensive Cancer Center, Winston-Salem

44308-1062

Children's Hospital Medical Center of Akron, Akron

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

44106-5000

Rainbow Babies and Children's Hospital, Cleveland

43205-2696

Columbus Children's Hospital, Columbus

45404-1815

Children's Medical Center - Dayton, Dayton

17822-0001

Geisinger Medical Center, Danville

17033-0850

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

19104-9786

Children's Hospital of Philadelphia, Philadelphia

19134-1095

St. Christopher's Hospital for Children, Philadelphia

02903

Rhode Island Hospital Comprehensive Cancer Center, Providence

57117-5039

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls

37232-6838

Vanderbilt-Ingram Cancer Center, Nashville

77030-2399

Baylor University Medical Center - Houston, Houston

77030-4009

M. D. Anderson Cancer Center at University of Texas, Houston

78229-3993

Methodist Children's Hospital of South Texas, San Antonio

84113-1100

Primary Children's Medical Center, Salt Lake City

05401

Fletcher Allen Health Care - University Health Center Campus, Burlington

22042-3300

INOVA Fairfax Hospital, Falls Church

23507-1971

Children's Hospital of The King's Daughters, Norfolk

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

23298-0037

Virginia Commonwealth University Massey Cancer Center, Richmond

99220-2555

Providence Cancer Center at Sacred Heart Medical Center, Spokane

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

53792-6164

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

T3B 6A8

Alberta Children's Hospital, Calgary

T6G 1Z2

University of Alberta Hospital, Edmonton

V6H 3V4

Children's & Women's Hospital of British Columbia, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

B3K 6R8

IWK Health Centre, Halifax

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

N6A 4G5

Children's Hospital of Western Ontario, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

H3T 1C5

Hopital Sainte Justine, Montreal

S4T 7T1

Allan Blair Cancer Centre at Pasqua Hospital, Regina

S7N 4H4

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon

G1V 4G2

Centre Hospitalier Universitaire de Quebec, Québec

9713 EZ

University Medical Center Groningen, Groningen

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00027846 - Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma | Biotech Hunter | Biotech Hunter