RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.

Condition	Treatment or Intervention	Phase
B-cell childhood acute lymphocytic leukemia untreated childhood acute lymphocytic leukemia	Drug: asparaginase  Drug: cyclophosphamide  Drug: cytarabine  Drug: daunorubicin  Drug: dexamethasone  Drug: leucovorin calcium  Drug: mercaptopurine  Drug: methotrexate  Drug: thioguanine  Drug: vincristine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in children with average risk acute lymphocytic leukemia.

II. Determine the feasibility of delivering 6 courses of this therapy in these patients.

PROTOCOL OUTLINE: This is a multicenter study.

Induction: Patients receive oral dexamethasone twice daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or M3 bone marrow on day 43 are taken off study.

Consolidation: Patients receive methotrexate IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion, methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24 until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks 8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29, daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21, and oral thioguanine daily during weeks 20 and 21.

Intensive continuation: Patients receive oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48 hours after the start of oral methotrexate. Patients also receive methotrexate IT during week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment repeats every 8 weeks for 6 courses.

Another continuation: Patients receive oral methotrexate once weekly except during the week of methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine.

Treatment continues for up to 130 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 4 years and then annually until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.

Ages Eligible for Study:  up to  18 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically newly diagnosed early B-cell or B-precursor or B-progenitor acute lymphocytic leukemia
• Prior registration on POG-9400, stratum 6 for induction therapy
• Average prognosis (neither very good nor very poor)

--Prior/Concurrent Therapy--

• No prior therapy other than on POG-9400

--Patient Characteristics--

• Age: Children
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: Not pregnant; Fertile patients must use effective contraception

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
California
      Kaiser Permanente Medical Center - Santa Clara, Santa Clara,  California,  95051-5386,  United States
      Kaiser Permanente-Southern California Permanente Medical Group, San Diego,  California,  92120,  United States
      Lucile Packard Children's Hospital at Stanford, Palo Alto,  California,  94304,  United States
      Naval Medical Center - San Diego, San Diego,  California,  92134-3202,  United States
      Sutter Cancer Center, Sacramento,  California,  95816,  United States
Florida
      Baptist Hospital of Miami, Miami,  Florida,  33176-2197,  United States
      Nemours Children's Clinic, Jacksonville,  Florida,  32207,  United States
      St. Mary's Hospital, West Palm Beach,  Florida,  33407,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
      Walt Disney Memorial Cancer Institute, Orlando,  Florida,  32803,  United States
Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
Hawaii
      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States
Illinois
      Children's Memorial Hospital, Chicago, Chicago,  Illinois,  60614,  United States
      Christ Hospital, Oak Lawn,  Illinois,  60453,  United States
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      Saint Jude Midwest Affiliate, Peoria,  Illinois,  61602,  United States
Kansas
      Via Christi Regional Medical Center-Saint Francis Campus, Wichita,  Kansas,  67214,  United States
Louisiana
      Tulane University School of Medicine, New Orleans,  Louisiana,  70112,  United States
Maine
      Eastern Maine Medical Center, Bangor,  Maine,  04401,  United States
      Maine Children's Cancer Program, Portland,  Maine,  04101,  United States
Massachusetts
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
Michigan
      Hurley Medical Center, Flint,  Michigan,  48503,  United States
      St. John's Hospital and Medical Center, Detroit,  Michigan,  48236,  United States
Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      University of Missouri-Columbia Hospital and Clinics, Columbia,  Missouri,  65212,  United States
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States
New Mexico
      University of New Mexico School of Medicine, Albuquerque,  New Mexico,  87131,  United States
New York
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11790-9832,  United States
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
Oklahoma
      Natalie Warren Bryant Cancer Center, Tulsa,  Oklahoma,  74136,  United States
      Oklahoma Memorial Hospital, Oklahoma City,  Oklahoma,  73126-0307,  United States
Tennessee
      James H. Quillen College of Medicine, Johnson City,  Tennessee,  37614-0622,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Cook Children's Medical Center - Fort Worth, Fort Worth,  Texas,  76104,  United States
      Medical City Dallas Hospital, Dallas,  Texas,  75230,  United States
      San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base,  Texas,  78236-5300,  United States
      Scott and White Clinic, Temple,  Texas,  76508,  United States
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-1329,  United States
Vermont
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
Virginia
      Carilion Roanoke Memorial Hospital, Roanoke,  Virginia,  24029,  United States
      Inova Fairfax Hospital, Falls Church,  Virginia,  22046,  United States
Washington
      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States
West Virginia
      West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9162,  United States
      West Virginia University Medical School, Charleston Division, Charleston,  West Virginia,  25304,  United States
Wisconsin
      Midwest Children's Cancer Center, Milwaukee,  Wisconsin,  53226,  United States
      St. Vincent Hospital, Green Bay,  Wisconsin,  54307-3508,  United States
Canada, Alberta
      Alberta Children's Hospital, Calgary,  Alberta,  T2T 5C7,  Canada
Canada, Ontario
      Children's Hospital of Eastern Ontario, Ottawa,  Ontario,  K1H 8L1,  Canada
Canada, Quebec
      Centre Hospitalier de L'Universite Laval, Sainte-Foy,  Quebec,  GIV 4G2,  Canada
      Montreal Children's Hospital, Montreal,  Quebec,  H3H 1P3,  Canada
Netherlands
      Academisch Ziekenhuis Groningen, Groningen,  9713 EZ,  Netherlands
Puerto Rico
      San Jorge Childrens Hospital, Santurce,  00912,  Puerto Rico
Switzerland
      Clinique de Pediatrie, Geneva,  1211,  Switzerland

Study chairs or principal investigators

Naomi J. Winick,  Study Chair,  Pediatric Oncology Group   

Study ID Numbers:  CDR0000066768; POG-9705
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003671
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08