Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

838

Participants

Timeline

Start Date

April 30, 2000

Primary Completion Date

July 31, 2007

Conditions
Leukemia
Interventions
DRUG

cyclophosphamide

Given IV

DRUG

cytarabine

Deoxycytidine analogue which is metabolized to ARA-CTP, a substance which inhibits DNA polymerase.

DRUG

daunorubicin hydrochloride

Given IV

DRUG

dexamethasone

Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.

DRUG

leucovorin calcium

Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)

DRUG

mercaptopurine

An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine

DRUG

methotrexate

A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis

DRUG

pegaspargase

E-Coli asparaginase deaminates asparagine, thus, is lethal for cells which cannot synthesize asparagine.

DRUG

thioguanine

Given orally

DRUG

vincristine sulfate

Given IV

Trial Locations (123)

2145

Children's Hospital at Westmead, Westmead

3052

Royal Children's Hospital, Parkville

4029

Royal Children's Hospital, Brisbane

10029

Mount Sinai Medical Center, New York

10128

Beth Israel Medical Center - Singer Division, New York

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

20910

Walter Reed Army Medical Center, Silver Spring

22908

University of Virginia Cancer Center, Charlottesville

24029

Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke

25302

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

27710

Duke Comprehensive Cancer Center, Durham

28233

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

28801

Mission Hospitals - Memorial Campus, Asheville

29605

Children's Hospital of Greenville Hospital System, Greenville

30101

University of Miami Sylvester Comprehensive Cancer Center, Miami

30342

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta

32207

Nemours Children's Clinic, Jacksonville

32504

Sacred Heart Children's Hospital, Pensacola

32804

Florida Hospital Cancer Institute, Orlando

32806

Nemours Children's Clinic-Orlando, Orlando

33021

Joe DiMaggio Children's Hospital at Memorial, Hollywood

33155

Miami Children's Hospital, Miami

33316

Broward General Medical Center, Fort Lauderdale

33407

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

33701

All Children's Hospital, St. Petersburg

33908

Children's Hospital of Southwest Florida, Fort Myers

35233

Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham

36604

University of South Alabama Cancer Research Institute, Mobile

38105

St. Jude Children's Research Hospital, Memphis

48201

Children's Hospital of Michigan, Detroit

48236

Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit

48503

Hurley Medical Center, Flint

53226

Midwest Children's Cancer Center, Milwaukee

54449

CCOP - Marshfield Clinic Research Foundation, Marshfield

60453

Advocate Hope Children's Hospital, 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

St. Louis Children's Hospital, St Louis

65203

University of Missouri - Columbia, Columbia

67214

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita

Wesley Medical Center, Wichita

70112

MBCCOP - LSU Health Sciences Center, New Orleans

Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans

70118

Children's Hospital of New Orleans, New Orleans

70121

Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans

72205

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

73104

Oklahoma University Medical Center, Oklahoma City

74136

Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa

75230

Medical City Dallas Hospital, Dallas

76104

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

76508

CCOP - Scott and White Hospital, Temple

Center for Cancer Prevention and Care at Scott and White Clinic, Temple

78207

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

78236

San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base

78466

Driscoll Children's Hospital, Corpus Christi

85724

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

87131

University of New Mexico Cancer Research and Treatment Center, Albuquerque

92120

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego

95816

Sutter Cancer Center, Sacramento

95817

University of California Davis Cancer Center, Sacramento

96813

Cancer Research Center of Hawaii, Honolulu

97225

CCOP - Columbia River Oncology Program, Portland

97227

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

92093-0658

Rebecca and John Moores UCSD Cancer Center, La Jolla

94304-1812

Stanford Cancer Center at Stanford University Medical Center, Palo Alto

92123-4282

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

95051-5386

Kaiser Permanente Medical Center - Santa Clara Kiely Campus, Santa Clara

06520-8064

Yale Comprehensive Cancer Center, New Haven

32610-0296

University of Florida Shands Cancer Center, Gainesville

33176-2197

Baptist-South Miami Regional Cancer Program, Miami

33677-4227

St. Joseph's Children's Hospital of Tampa, Tampa

30912-4000

MBCCOP-Medical College of Georgia Cancer Center, Augusta

96859-5000

Tripler Army Medical Center, Honolulu

66160-7357

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

67214-3882

CCOP - Wichita, Wichita

04401

Pediatric Specialty Clinic at Eastern Maine Medical Center, Bangor

04074-9308

Maine Children's Cancer Program, Scarborough

21201-1595

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

21231-7223

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

02111

Floating Hospital for Children, Boston

02114-2696

Massachusetts General Hospital Cancer Center, Boston

02115

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

01655

UMASS Memorial Cancer Center - University Campus, Worcester

39216-4505

University of Mississippi Medical Center, Jackson

39534-2511

Keesler Medical Center - Keesler Air Force Base, Keesler Air Force Base

03756

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

07601

Hackensack University Medical Center, Hackensack

14263-0001

Roswell Park Cancer Institute, Buffalo

11794-8174

Long Island Cancer Center at Stony Brook University Hospital, Stony Brook

28232-2861

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte

27858-4354

Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital, Greenville

27157-1081

Comprehensive Cancer Center at Wake Forest University, Winston-Salem

19134-1095

St. Christopher's Hospital for Children, Philadelphia

02903

Rhode Island Hospital, Providence

29425-0721

Hollings Cancer Center at Medical University of South Carolina, Charleston

37614-0622

East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City

75390-9063

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

77555-0209

University of Texas Medical Branch, Galveston

77030-2399

Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital, Houston

78229-3900

MBCCOP - South Texas Pediatrics, San Antonio

05401-3498

Vermont Cancer Center at University of Vermont, Burlington

22042-3300

INOVA Fairfax Hospital, Falls Church

23708-5100

Naval Medical Center - Portsmouth, Portsmouth

23298-0121

Massey Cancer Center at Virginia Commonwealth University, Richmond

98431-0001

Madigan Army Medical Center, Tacoma

26506-9300

Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown

54307-9070

St. Vincent Hospital, Green Bay

T2T 5C7

Alberta Children's Hospital, Calgary

T6G 1Z2

Cross Cancer Institute at University of Alberta, Edmonton

L8S 4J9

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

H3G 1A4

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

H3T 1C5

Hopital Sainte Justine, Montreal

GIV 4G2

Centre de Recherche du Centre Hospitalier de l'Universite Laval, Sainte-Foy

9700 RB

University Medical Center Groningen, Groningen

00912

San Jorge Children's Hospital, Santurce

CH 3010

Swiss Pediatric Oncology Group Bern, Bern

CH 1211

Swiss Pediatric Oncology Group Geneva, Geneva

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00005585 - Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter