Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors

NACompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

April 30, 2007

Conditions
Childhood Germ Cell TumorExtragonadal Germ Cell Tumor
Interventions
BIOLOGICAL

bleomycin sulfate

Given IV over 10 minutes. Children ≥ 12 months: 15 units/m2/dose Children \< 12 months: 0.5 units/kg/dose Day 1 (Week 1, 4, 7, 10)

BIOLOGICAL

filgrastim

Given SQ once daily 5 micrograms/kg/dose Starting on Day 6 (Week 1, 4, 7, 10) Daily until ANC \> 5,000/uL

DRUG

cisplatin

Children ≥ 12 months: Given IV over one hour Dose: 20 mg/m2/dose Days 1-5 (Week 1,4,7,10) Children \< 12 months: Given IV over 4 hours, 0.67 mg/kg/dose Days 1-5 (Week 1,4,7,10)

DRUG

cyclophosphamide

Given IV over 1 hour. Children ≥ 12 months: Level 1: 1.2 g/m2/dose Level 2: 1.8 g/m2/dose Level 3: 2.4 g/m2/dose Children \< 12 months: Level 1: 40 mg/kg/dose Level 2: 60 mg/kg/dose Level 3: 80 mg/kg/dose Day 1 (Week 1, 4, 7, 10)

DRUG

etoposide

Given IV over 1 hour. Children ≥ 12 months: 100 mg/m2/dose Children \< 12 months: 3.3 mg/kg/dose Day 1-5 (Week 1, 4, 7, 10)

PROCEDURE

conventional surgery

Stage III/IV extragonadal tumors: biopsy followed by a definitive surgical excision after maximal chemotherapy effect, likely after 4 cycles of therapy

BIOLOGICAL

MESNA

Given IV or oral. The total daily MESNA dose is equal to at least 80% of the daily CPM dose. The oral dose of MESNA is 2x the IV dose. Day 1 (Week 1,4,7,10) To be given with CPM.

Trial Locations (98)

6001

Princess Margaret Hospital for Children, Perth

10461

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

10595

New York Medical College, Valhalla

13210

SUNY Upstate Medical University Hospital, Syracuse

14642

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

19899

Alfred I. duPont Hospital for Children, Wilmington

21215

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore

22031

INOVA Fairfax Hospital, Fairfax

24029

Carilion Cancer Center of Western Virginia, Roanoke

25302

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

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

Emory University Hospital - Atlanta, Atlanta

32207

Nemours Children's Clinic, Jacksonville

32504

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola

33136

University of Miami Sylvester Comprehensive Cancer Center, Miami

33155

Miami Children's Hospital, Miami

33176

Baptist-South Miami Regional Cancer Program, 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

Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham

37916

East Tennessee Children's Hospital, Knoxville

38105

St. Jude Children's Research Hospital, Memphis

44501

Tod Children's Hospital - Forum Health, 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

53226

Midwest Children's Cancer Center, Milwaukee

54449

Marshfield Clinic - Marshfield Center, Marshfield

55404

Children's Hospital of Minnesota - Minneapolis, Minneapolis

55455

Fairview University Medical Center - University Campus, Minneapolis

55905

Mayo Clinic Cancer Center, Rochester

60614

Children's Memorial Hospital - Chicago, Chicago

61637

Saint Jude Midwest Affiliate, Peoria

63110

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis

64108

Children's Mercy Hospital, Kansas City

65203

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia

72205

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

73104

Oklahoma University Medical Center, Oklahoma City

75230

Medical City Dallas Hospital, Dallas

75390

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

78466

Driscoll Children's Hospital, Corpus Christi

78701

Children's Hospital of Austin, Austin

79106

Texas Tech University Health Sciences Center School of Medicine, Amarillo

79410

Covenant Children's Hospital, Lubbock

90027

Children's Hospital Los Angeles, Los Angeles

92354

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

92868

Children's Hospital of Orange County, Orange

94305

Stanford Cancer Center at Stanford University Medical Center, Stanford

95813

Cancer Research Center of Hawaii, Honolulu

95825

Kaiser Permanente Medical Center - Oakland, Sacramento

85016-7710

Phoenix Children's Hospital, Phoenix

90242-2814

Southern California Permanente Medical Group, Downey

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

20010-2970

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

32610-0232

University of Florida Shands Cancer Center, Gainesville

62794-9620

Southern Illinois University School of Medicine, Springfield

66160-7357

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

40536-0293

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

04401

CancerCare of Maine at Eastern Maine Medial Center, Bangor

02115

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

48109-0238

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

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

49503-2560

Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids

39216-4505

University of Mississippi Medical Center, Jackson

07601

Hackensack University Medical Center Cancer Center, Hackensack

07039

St. Barnabas Medical Center, Livingston

28232-2861

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

44308-1062

Children's Hospital Medical Center of Akron, Akron

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

45404-1815

Children's Medical Center - Dayton, Dayton

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

76104-9958

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

77030-2399

Baylor University Medical Center - Houston, Houston

77030-4009

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

78229-3900

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

78229-3993

Methodist Children's Hospital of South Texas, San Antonio

84113-1100

Primary Children's Medical Center, Salt Lake City

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

53792-6164

University of Wisconsin Comprehensive Cancer Center, Madison

V6H 3V4

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

A1B 3V6

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

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

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

G1V 4G2

Centre Hospitalier Universitaire de Quebec, Ste-Foy

S4T 7T1

Allan Blair Cancer Centre at Pasqua Hospital, Regina

00912

San Jorge Children's Hospital, Santurce

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00066482 - Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors | Biotech Hunter | Biotech Hunter