High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma

PHASE3CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

January 31, 2010

Study Completion Date

June 30, 2019

Conditions
Sarcoma
Interventions
BIOLOGICAL

dactinomycin

"Age based dosage: ≥ 1 year 0.045 mg/kg IV x 1(maximum dose 2.5 mg), \< 1 year 0.025 mg/kg.~Day 1 of Weeks 35, 38, 41 and 44.~Given IV"

DRUG

cyclophosphamide

"Age based dosage: ≥ 3 years 1200 mg/m2, \<3 years 40 mg/kg.~Day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 and 44.~Given IV"

DRUG

doxorubicin hydrochloride

"Age based dosage: ≥ 1 year: 37.5mg/m²/day, \< 1 year: treat with 50% doses calculated on a m2 basis. Total dose 75 mg/m².~Days 1 and 2 of weeks 7, 11, 15, 28 and 32.~Given IV"

DRUG

etoposide

"Age based dosage: ≥ 1 year: 100 mg/m²/day, \< 1 year: treat with 50% doses calculated on a m2 basis.~Days 1-5 of weeks 9, 13, 17, 26 and 30.~Given IV"

DRUG

ifosfamide

"Age based dosage: ≥ 1 year: 1800 mg/m²/day, \< 1 year: treat with 50% doses calculated on a m2 basis.~Days 1-5 of weeks 9, 13, 17, 26 and 30.~Given IV"

DRUG

irinotecan hydrochloride

"Dosage 50 mg/m2-max dose 100 mg/day.~Days 1-5 of weeks 1, 4, 20, 23, 47 and 50.~Given IV"

DRUG

vincristine sulfate

"Age based dosage: ≥ 3 years 1.5 mg/m2 (max dose 2 mg), ≥ 1 year and \< 3 years 0.05 mg/kg (max dose 2 mg), \< 1 year 0.025 mg/kg.~Days 1-5 of weeks 1, 2, 3, 4, 5, 7, 8, 11, 12, 15, 16, 20, 21, 22, 23, 24, 28, 29, 32, 33, 35, 38, 41, 42, 43, 44, 47, 48, 50, and 51.~Given IV"

PROCEDURE

conventional surgery

"Resection of the primary tumor with a surrounding envelope of normal tissue"

RADIATION

radiation therapy

Radiotherapy beginning at Week 20 to the primary tumor and to the metastatic sites excepting those with parameningeal tumors with intracranial extension (direct extension into the brain) and those requiring emergency radiotherapy

BIOLOGICAL

filgrastim

"5 micrograms/kg/day (max 300 micrograms) beginning 24-36 hours after the last dose of chemotherapy. Continue at least 7 days, or until the ANC ≥750/μL whichever comes last.~Given subcutaneously."

Trial Locations (166)

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

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

18107

Lehigh Valley Hospital - Muhlenberg, Bethlehem

19803

Alfred I. duPont Hospital for Children, Wilmington

20007

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington D.C.

21215

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore

24029

Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke

25302

West Virginia University Health Sciences Center - Charleston, Charleston

27710

Duke Comprehensive Cancer Center, Durham

28801

Mission Hospitals - Memorial Campus, Asheville

29203

Palmetto Health South Carolina Cancer Center, Columbia

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

29605

Greenville Hospital 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

M.D. Anderson Cancer Center at Orlando, Orlando

Nemours Children's Clinic - Orlando, Orlando

33021

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood

33155

Miami Children's Hospital, Miami

33176

Baptist-South Miami Regional Cancer Program, Miami

33316

Broward General Medical Center Cancer Center, Fort Lauderdale

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

46260

St. Vincent Indianapolis Hospital, Indianapolis

48503

Hurley Medical Center, Flint

48910

Breslin Cancer Center at Ingham Regional Medical Center, Lansing

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, Minneapolis

55905

Mayo Clinic Cancer Center, Rochester

60453

Advocate Christ Medical Center, Oak Lawn

60614

Children's Memorial Hospital - Chicago, Chicago

61637

Saint Jude Midwest Affiliate, Peoria

63110

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis, St Louis

64108

Children's Mercy Hospital, Kansas City

70118

Children's Hospital of New Orleans, New Orleans

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

78207

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

78411

Driscoll Children's Hospital, Corpus Christi

78723

Dell Children's Medical Center of Central Texas, Austin

79106

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

79410

Covenant Children's Hospital, Lubbock

80045

Children's Hospital Center for Cancer and Blood Disorders, Aurora

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 Helen Diller Family Comprehensive Cancer Center, San Francisco

94609

Children's Hospital and 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

98105

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

98405

Mary Bridge Children's Hospital and Health Center - Tacoma, Tacoma

85016-7710

Phoenix Children's Hospital, Phoenix

85724-5024

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

90242-2814

Southern California Permanente Medical Group, Downey

93638-8762

Children's Hospital Central California, Madera

92123-4282

Rady Children's Hospital - San Diego, San Diego

94305-5824

Stanford Cancer Center, Stanford

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.

20307-5001

Walter Reed Army 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

31403-3089

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah

60612-7243

University of Illinois Cancer Center, Chicago

60637-1470

University of Chicago Cancer Research Center, Chicago

60068-1174

Advocate Lutheran General Cancer Care Center, Park Ridge

62794-9677

Simmons Cooper Cancer Institute, Springfield

46202-5289

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

66160-7357

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City

40536-0093

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

71315-3198

Tulane Cancer Center Office of Clinical Research, Alexandria

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

Butterworth Hospital at Spectrum Health, Grand Rapids

49007-5341

CCOP - Kalamazoo, Kalamazoo

39216-4505

University of Mississippi Cancer Clinic, Jackson

68114-4113

Children's Hospital, Omaha

68198-6805

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha

89109-2306

Sunrise Hospital and Medical Center, Las Vegas

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

07601

Hackensack University Medical Center Cancer Center, Hackensack

07962

Overlook Hospital, Morristown

08903

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

07112

Newark Beth Israel Medical Center, Newark

07503

St. Joseph's Hospital and Medical Center, Paterson

87131-5636

University of New Mexico Cancer Center, Albuquerque

12208-3419

Albany Medical Center Hospital, Albany

14263-0001

Roswell Park Cancer Institute, Buffalo

11794-9446

Stony Brook University Cancer Center, Stony Brook

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

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

Akron Children's Hospital, Akron

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

44106-5000

Rainbow Babies and Children's Hospital, Cleveland

43205-2696

Nationwide Children's Hospital, Columbus

45404-1815

Children's Medical Center - Dayton, Dayton

97239-3098

Oregon Health and Science University Cancer Institute, Portland

17822-0001

Geisinger Cancer Institute at Geisinger Health, Danville

17033-0850

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

19104-9786

Children's Hospital of Philadelphia, Philadelphia

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

99220-2555

Providence Cancer Center at Sacred Heart Medical Center, Spokane

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

A1B 3V6

Janeway Children's Health and Rehabilitation Centre, St. John's

B3K 6R8

IWK Health Centre, Halifax

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

K7L 3N6

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston

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

H3H 1P3

Montreal Children's Hospital at McGill University Health Center, Montreal

H3T 1C5

Hopital Sainte Justine, Montreal

S7N 4H4

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon

G1V 4G2

Centre Hospitalier Universitaire de Quebec, Québec

00912

San Jorge Children's Hospital, Santurce

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00354744 - High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma | Biotech Hunter | Biotech Hunter