SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 31, 1995

Primary Completion Date

December 31, 2001

Study Completion Date

December 31, 2003

Conditions
LeukemiaNeutropeniaThrombocytopenia
Interventions
DRUG

asparaginase

10,000 units/d IV or IM 15 - 24

DRUG

cyclophosphamide

con: 650 mg/m2 IV 1, 15, 29 maint: 650 mg/m2 IV 1

DRUG

cytarabine

cons: 75 mg/m2/d IV Push 2 - 5, 9 - 12, 6 - 19, 23 - 26

DRUG

daunorubicin hydrochloride

ind: 60 mg/m2 IV 22 and 23

DRUG

dexamethasone

main: 10 mg/m2/day PO 1 - 28

DRUG

doxorubicin hydrochloride

main: 25 mg/m2 IV 1, 8, 15, and 22

DRUG

etoposide

60 mg/kg based on ideal body weight day -3

DRUG

leucovorin calcium

5 mg q 6 hours for 4 doses, PO 1, 3, 8, 11 after each methotrexate if WBC \< 3,000 /μl

DRUG

mercaptopurine

con: 60 mg/m2 PO 1 - 28

DRUG

methotrexate

10 mg/m2 IT or IV, d 2, 9, 16, and 23; Maximum 15 mg/admin

DRUG

prednisone

"ind: 60 mg/m2/d PO 1 - 21\*, 22 - 28 Patients will receive full dose through day 8 and then tapered to zero between Day 29 and 42.~ind2: 60 mg/m2/d PO through day 42"

DRUG

thioguanine

main: 60 mg/m2/day PO 1 - 14

DRUG

vincristine sulfate

ind: 1.4 mg/m2 2 mg max, IV 1, 8, 15, and 22 ind2: 1.4 mg/m2 2 mg max IV 29 and 36 main: 1.5 mg/m2 2 mg max, IV 1, 8, 15, and 22

PROCEDURE

allogeneic bone marrow transplantation

day 0

RADIATION

radiation therapy

day -7 through day -4 total dose of radiation is 1,320 cGy.

Trial Locations (83)

10032

Herbert Irving Comprehensive Cancer Center, New York

11209

Veterans Affairs Medical Center - Brooklyn, Brooklyn

29303

CCOP - Upstate Carolina, Spartanburg

29615

CCOP - Greenville, Greenville

36688

MBCCOP - University of South Alabama, Mobile

39216

Veterans Affairs Medical Center - Jackson, Jackson

43206

CCOP - Columbus, Columbus

44195

Cleveland Clinic Cancer Center, Cleveland

45219

Barrett Cancer Center, The University Hospital, Cincinnati

45428

Veterans Affairs Medical Center - Dayton, Dayton

45429

CCOP - Dayton, Kettering

48105

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute, Detroit

48202

Henry Ford Hospital, Detroit

49503

CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids

59101

CCOP - Montana Cancer Consortium, Billings

60141

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines

60153

Loyola University Medical Center, Maywood

62526

CCOP - Central Illinois, Springfield

63141

CCOP - St. Louis-Cape Girardeau, St Louis

64128

Veterans Affairs Medical Center - Kansas City, Kansas City

64131

CCOP - Kansas City, Kansas City

65807

CCOP - Cancer Research for the Ozarks, Springfield

67218

Veterans Affairs Medical Center - Wichita, Wichita

70112

MBCCOP - LSU Medical Center, New Orleans

Tulane University School of Medicine, New Orleans

Veterans Affairs Medical Center - New Orleans, New Orleans

71130

Veterans Affairs Medical Center - Shreveport, Shreveport

72205

University of Arkansas for Medical Sciences, Little Rock

Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock

73104

Oklahoma Medical Research Foundation, Oklahoma City

Veterans Affairs Medical Center - Oklahoma City, Oklahoma City

76504

Veterans Affairs Medical Center - Temple, Temple

76508

CCOP - Scott and White Hospital, Temple

78234

Brooke Army Medical Center, Fort Sam Houston

78284

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

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio

79423

Texas Tech University Health Science Center, Lubbock

80220

Veterans Affairs Medical Center - Denver, Denver

80262

University of Colorado Cancer Center, Denver

84132

Huntsman Cancer Institute, Salt Lake City

84148

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City

85012

Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix

85723

Veterans Affairs Medical Center - Tucson, Tucson

85724

Arizona Cancer Center, Tucson

87131

University of New Mexico Cancer Research & Treatment Center, Albuquerque

90822

Veterans Affairs Medical Center - Long Beach, Long Beach

91010

Beckman Research Institute, City of Hope, Duarte

94535

David Grant Medical Center, Travis Air Force Base

94553

Veterans Affairs Outpatient Clinic - Martinez, Martinez

95403

CCOP - Santa Rosa Memorial Hospital, Santa Rosa

95817

University of California Davis Medical Center, Sacramento

96813

Cancer Research Center of Hawaii, Honolulu

97207

Veterans Affairs Medical Center - Portland, Portland

97213

CCOP - Columbia River Program, Portland

98101

CCOP - Virginia Mason Research Center, Seattle

98104

Swedish Cancer Institute, Seattle

98108

Veterans Affairs Medical Center - Seattle, Seattle

85006-2726

CCOP - Greater Phoenix, Phoenix

90033-0800

USC/Norris Comprehensive Cancer Center, Los Angeles

90095-1781

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles

94609-3305

CCOP - Bay Area Tumor Institute, Oakland

30342-1701

CCOP - Atlanta Regional, Atlanta

30905-5650

Dwight David Eisenhower Army Medical Center, Fort Gordon

66160-7357

University of Kansas Medical Center, Kansas City

67214-3882

CCOP - Wichita, Wichita

40511-1093

Veterans Affairs Medical Center - Lexington, Lexington

40536-0084

Albert B. Chandler Medical Center, University of Kentucky, Lexington

71130-3932

Louisiana State University Hospital - Shreveport, Shreveport

02118

Boston Medical Center, Boston

02130

Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain

48109-0752

University of Michigan Comprehensive Cancer Center, Ann Arbor

48201-1932

Veterans Affairs Medical Center - Detroit, Detroit

48075-9975

Providence Hospital - Southfield, Southfield

39531-2410

Veterans Affairs Medical Center - Biloxi, Biloxi

39216-4505

University of Mississippi Medical Center, Jackson

39534-2576

Keesler Medical Center - Keesler AFB, Keesler Air Force Base

63110-0250

St. Louis University Health Sciences Center, St Louis

87108-5138

Veterans Affairs Medical Center - Albuquerque, Albuquerque

45220-2288

Veterans Affairs Medical Center - Cincinnati, Cincinnati

97201-3098

Oregon Cancer Center at Oregon Health Sciences University, Portland

77555-1329

University of Texas Medical Branch, Galveston

98405-0986

CCOP - Northwest, Tacoma

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

SWOG Cancer Research Network

NETWORK

NCT00002665 - SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia | Biotech Hunter | Biotech Hunter