S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2014

Conditions
Leukemia
Interventions
BIOLOGICAL

filgrastim

As needed per physician discretion

DRUG

cyclophosphamide

Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1

DRUG

cytarabine

Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13

DRUG

daunorubicin

Induction: 60 mg/m2/d; IV; days 1, 2, and 3

DRUG

dexamethasone

Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28

DRUG

doxorubicin

Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22

DRUG

leucovorin

For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC \< 3,000

DRUG

mercaptopurine

Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs

DRUG

methotrexate

Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs

DRUG

mitoxantrone

Induction 2: 80 mg/m2; IV; day 3

DRUG

Asparaginase

Induction: 2,000 IU/m2; IM or IV; day 15

DRUG

prednisone

Induction: 60 mg/m2/d; PO or IV; days 1-35

DRUG

thioguanine

Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14

DRUG

vincristine

Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22

RADIATION

radiation therapy

For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.

DRUG

allopurinol

300 mg/d PO Days 1-7

DRUG

bactrim

1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone

Trial Locations (78)

27534

Wayne Memorial Hospital, Incorporated, Goldsboro

28139

Rutherford Hospital, Rutherfordton

29303

CCOP - Upstate Carolina, Spartanburg

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

29501

McLeod Regional Medical Center, Florence

29621

AnMed Cancer Center, Anderson

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

59101

CCOP - Montana Cancer Consortium, Billings

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings

Northern Rockies Radiation Oncology Center, Billings

St. Vincent Healthcare Cancer Care Services, Billings

59405

Frontier Cancer Center, Great Falls

Great Falls Clinic - Main Facility, Great Falls

Sletten Cancer Institute at Benefis Healthcare, Great Falls

59501

Northern Montana Hospital, Havre

59601

St. Peter's Hospital, Helena

59701

St. James Healthcare Cancer Care, Butte

59715

Bozeman Deaconess Cancer Center, Bozeman

59801

Community Medical Center, Missoula

59804

Guardian Oncology and Center for Wellness, Missoula

59807

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula

59901

Glacier Oncology, PLLC, Kalispell

Kalispell Medical Oncology at KRMC, Kalispell

Kalispell Regional Medical Center, Kalispell

60153

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood

64050

Independence Regional Health Center, Independence

64068

Liberty Hospital, Liberty

64086

Saint Luke's East - Lee's Summit, Lee's Summit

64108

Truman Medical Center - Hospital Hill, Kansas City

64111

Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City

64114

St. Joseph Medical Center, Kansas City

64116

North Kansas City Hospital, Kansas City

Parvin Radiation Oncology, Kansas City

64131

CCOP - Kansas City, Kansas City

64132

Research Medical Center, Kansas City

64506

Heartland Regional Medical Center, Saint Joseph

66044

Lawrence Memorial Hospital, Lawrence

66204

Shawnee Mission Medical Center, Shawnee Mission

66209

Menorah Medical Center, Overland Park

66720

Cancer Center of Kansas, PA - Chanute, Chanute

67042

Cancer Center of Kansas, PA - El Dorado, El Dorado

Cancer Center of Kansas, PA - Salina, Salina

67068

Cancer Center of Kansas, PA - Kingman, Kingman

67114

Cancer Center of Kansas, PA - Newton, Newton

67124

Cancer Center of Kansas, PA - Pratt, Pratt

67152

Cancer Center of Kansas, PA - Wellington, Wellington

67156

Cancer Center of Kansas, PA - Winfield, Winfield

67208

Associates in Womens Health, PA - North Review, Wichita

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita

67214

Cancer Center of Kansas, PA - Wichita, Wichita

CCOP - Wichita, Wichita

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

Wesley Medical Center, Wichita

67301

Cancer Center of Kansas-Independence, Independence

67357

Cancer Center of Kansas, PA - Parsons, Parsons

67801

Cancer Center of Kansas, PA - Dodge City, Dodge City

67901

Southwest Medical Center, Liberal

82609

Rocky Mountain Oncology, Casper

82801

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

91505

Providence Saint Joseph Medical Center - Burbank, Burbank

98104

Fred Hutchinson Cancer Research Center, Seattle

Harborview Medical Center, Seattle

Minor and James Medical, PLLC, Seattle

98112

Group Health Central Hospital, Seattle

98122

Polyclinic First Hill, Seattle

98225

St. Joseph Cancer Center, Bellingham

98310

Olympic Hematology and Oncology, Bremerton

99202

Cancer Care Northwest - Spokane South, Spokane

99336

Columbia Basin Hematology, Kennewick

48109-0942

University of Michigan Comprehensive Cancer Center, Ann Arbor

59107-7000

Billings Clinic - Downtown, Billings

59405-5309

Big Sky Oncology, Great Falls

59807-7877

Montana Cancer Specialists at Montana Cancer Center, Missoula

98122-4307

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle

98195-6043

University Cancer Center at University of Washington Medical Center, Seattle

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

SWOG Cancer Research Network

NETWORK

NCT00109837 - S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter