RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating childhood acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is comparing different combination chemotherapy regimens to see how well they work in treating children with acute lymphoblastic leukemia.

Condition	Treatment or Intervention	Phase
untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia L3 childhood acute lymphoblastic leukemia	Drug: cyclophosphamide  Drug: cytarabine  Drug: daunorubicin  Drug: dexamethasone  Drug: doxorubicin  Drug: mercaptopurine  Drug: methotrexate  Drug: pegaspargase  Drug: thioguanine  Drug: vincristine  Procedure: chemotherapy  Procedure: radiation therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the event-free survival and overall survival of children with standard-risk acute lymphoblastic leukemia treated with escalating-dose IV methotrexate without leucovorin calcium versus oral methotrexate during the interim maintenance phase of therapy.
• Compare the event-free survival and overall survival of these patients after receiving treatment in two delayed intensification phases versus one delayed intensification phase.
• Compare the toxic effects of oral versus escalating-dose intravenous methotrexate in these patients.
• Determine the prognostic significance of the rate of disappearance of peripheral lymphoblasts and lymphocytes during the first week of treatment in these patients.
• Determine the prognostic significance of trisomies of chromosomes 4, 5, 10, and 17 and early treatment response in patients treated with these regimens.
• Determine the prognostic significance of the TEL-AML1 fusion transcript and early treatment response in patients treated with these regimens.
• Determine the minimal residual disease (MRD) by polymerase chain reaction in bone marrow and cerebrospinal fluid at various stages of therapy in these patients.
• Determine the prognostic significance of MRD during various stages of therapy in these patients.
• Determine whether a second delayed intensification therapy improves the prognosis of patients who have MRD at the end of induction therapy.

OUTLINE: This is a randomized, multicenter study. Patients without CNS disease at diagnosis, achieving a specified early marrow response profile and M1 marrow status of less than 5% blasts in the bone marrow (regardless of the proportion of mature lymphocytes) by day 28 of induction therapy, and remaining event free with favorable bone marrow status and cytogenetics between day 21 and 28 of consolidation therapy are randomized to one of four treatment arms. Patients with CNS disease at diagnosis are assigned to treatment arm II and undergo cranial irradiation. Patients with any of the following unfavorable bone marrow features and/or unfavorable cytogenetic features are assigned to the augmented treatment regimen by day 21 of induction chemotherapy or at the beginning of consolidation chemotherapy:

NOTE: All T-cell precursor patients that are not more than 4 months past completion of the delayed intensification phase of therapy should be switched to the augmented regimen as of 3/8/2004. These patients may be switched to the augmented regimen. The protocol gives specific instructions according to the phase of therapy the patients are actually in.

• 5-25% blasts in bone marrow at day 28 of induction chemotherapy (or at day 14 of induction chemotherapy if day 7 status is M3) OR
• M3: More than 25% blast cell in bone marrow, regardless of the proportion of mature lymphocytes at day 14 of induction chemotherapy
• Must have 1 of the following:
• t(9;22)(q34;q11)
• t(4;11)(q21;q23)
• Balanced t(1;19)(q23;p13)
• Hypodiploidy with less than 45 chromosomes
• Other 11q23 translocations involving MLL Patients receive standard induction chemotherapy comprising cytarabine (ARA-C) intrathecally (IT) on day 0 or up to 72 hours before day 0; oral dexamethasone (DM) twice daily on days 0-27; vincristine (VCR) IV on days 0, 7, 14, and 21; and pegaspargase (PEG-ASP) intramuscularly (IM) once between days 3-5. Patients without CNS disease at diagnosis receive methotrexate (MTX) IT on days 7 and 28. Patients with CNS disease at diagnosis receive MTX IT on days 7, 14, 21, and 28.

Patients who have achieved M1 marrow status by day 28 of induction therapy and have favorable early bone marrow response and cytogenetics proceed to standard consolidation therapy once blood counts have recovered. Patients with M3 bone marrow status at day 28 of induction therapy are taken off the protocol. All other patients are assigned to the augmented treatment regimen.

Beginning on day 28 of induction chemotherapy, patients receive standard consolidation chemotherapy comprising VCR IV on day 0 and oral mercaptopurine (MP) on days 0-27. Patients without CNS disease at diagnosis receive MTX IT on days 7, 14, 21, and 28. Patients with CNS disease at diagnosis receive MTX IT on day 7 and cranial irradiation 5 days a week for 2 weeks. Patients with testicular disease receive bilateral testicular radiotherapy 5 days a week for 1 week and then for 3 consecutive days during the next week.

NOTE: As of 3/8/2004, patients with T-cell disease who did not achieve M1 marrow status by day 14 of induction OR who did not receive augmented induction and/or consolidation (regardless of early marrow status) receive cranial irradiation.

• Beginning on day 28 of consolidation chemotherapy, patients receive interim maintenance I chemotherapy comprising oral DM twice daily on days 0-4 and 28-32; VCR IV on days 0 and 28; oral MTX on days 0, 7, 14, 21, 28, 35, 42, and 49; oral MP on days 0-49; and MTX IT on day 28. Beginning on day 56 of interim maintenance I chemotherapy, patients receive delayed intensification chemotherapy comprising oral DM twice daily on days 0-6 and 14-20; VCR IV and doxorubicin (DOX) IV over 15 minutes to 2 hours on days 0, 7, and 14; PEG-ASP IM on day 3; cyclophosphamide (CTX) IV over 20-30 minutes on day 28; oral thioguanine (TG) on days 28-41; ARA-C IV or subcutaneously (SC) daily on days 28-31 and 35-38; and MTX IT on days 0 and 28.

Beginning on day 56 of delayed intensification chemotherapy, patients receive interim maintenance II chemotherapy identical to interim maintenance I chemotherapy except patients receive MTX IT on days 0 and 28.

Beginning on day 56 of interim maintenance II chemotherapy, patients receive maintenance chemotherapy comprising oral DM twice daily on days 0-4, 28-32, and 56-60; VCR IV on days 0, 28, and 56; oral MP on days 0-83; oral MTX on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; and MTX IT on day 0.

• Arm II: Patients receive interim maintenance I chemotherapy, delayed intensification chemotherapy, and interim maintenance II chemotherapy as in arm I. Beginning on day 56 of interim maintenance II chemotherapy, patients then receive a second course of delayed intensification chemotherapy followed by maintenance chemotherapy as in arm I.
• Arm III: Beginning on day 28 of consolidation chemotherapy, patients receive interim maintenance I chemotherapy comprising VCR IV; escalating doses of MTX IV on days 0, 10, 20, 30, and 40; and MTX IT on day 30. Patients then receive delayed intensification chemotherapy as in arm I. Patients receive interim maintenance II chemotherapy as in interim maintenance I chemotherapy, but with IV MTX starting at 2/3 of the maximum tolerated dose (MTD) attained in interim maintenance I chemotherapy. Patients then receive maintenance chemotherapy as in arm I.
• Arm IV: Patients receive interim maintenance I chemotherapy as in arm III, delayed intensification chemotherapy as in arm I, interim maintenance II chemotherapy as in arm III, delayed intensification II chemotherapy as in arm II, and maintenance chemotherapy as in arm I.
• Patients receive induction chemotherapy comprising daunorubicin IV continuously for 48 hours beginning no later than day 21; oral DM twice daily on days 14-27; and VCR IV on days 14 and 21. Patients without CNS disease at diagnosis receive MTX IT on days 21 and 35. Patients with CNS disease at diagnosis receive MTX IT on days 21 and 28. NOTE: Patients with T-cell disease should re-start with augmented consolidation and proceed as per the augmented regimen.

Beginning on day 35 of induction chemotherapy, patients receive consolidation therapy comprising CTX IV over 20-30 minutes on days 0 and 28; oral MP on days 0-13 and 28-41; ARA-C IV or SC daily on days 0-3, 7-10, 28-31, and 35-38; VCR IV on days 14, 21, 42, and 49; and PEG-ASP IM on days 14 and 42. Patients without CNS disease at diagnosis receive MTX IT on days 7, 14, and 21. Patients with CNS disease at diagnosis receive MTX IT on day 7 and cranial irradiation as in the randomized treatment section. Patients with testicular leukemia receive radiotherapy as in the randomized treatment section.

Beginning on day 63 of consolidation chemotherapy, patients receive interim maintenance I chemotherapy comprising VCR IV on days 0, 10, 20, 30, and 40; escalating doses of MTX IV on days 10, 20, 30, and 40; PEG-ASP IM on days 1 and 21; and MTX IT on days 0 and 30.

Beginning on day 56 of interim maintenance I chemotherapy, patients receive delayed intensification I chemotherapy comprising oral DM twice daily on days 0-6 and 14-20; VCR IV on days 0, 7, 14, 42, and 49; DOX IV over 15 minutes to 2 hours on days 0, 7, and 14; PEG-ASP IM on days 3 and 42; CTX IV over 20-30 minutes on day 28; oral TG on days 28-41; ARA-C IV or SC daily on days 28-31 and 35-38; and MTX IT on days 0 and 28.

NOTE: Patients with T-cell disease who are in interim maintenance I chemotherapy with escalating IV methotrexate should continue this phase and then proceed as per the augmented regimen. If these patients are receiving conventional interim maintenance chemotherapy with oral methotrexate, they should stop and restart the interim maintenance as per the augmented regimen. These patients receive cranial irradiation starting on day 28 of delayed intensification II chemotherapy.

Beginning on day 56 of delayed intensification I chemotherapy, patients receive interim maintenance II chemotherapy as in interim maintenance I chemotherapy, but with IV MTX starting at 2/3 of the MTD attained in interim maintenance I chemotherapy.

NOTE: Patients with T-cell disease who are in delayed intensification I chemotherapy proceed with this phase, with the addition of 2 vincristine doses on days 42 and 49 and PEG-ASP on day 42. These patients then proceed as per the augmented regimen with the addition of cranial irradiation starting on day 28 of delayed intensification II chemotherapy.

NOTE: Patients with T-cell disease who are within 4 months of completing delayed intensification I chemotherapy and have not received interim maintenance II chemotherapy with escalating IV methotrexate or delayed intensification II chemotherapy receive a course of interim maintenance chemotherapy and delayed intensification II chemotherapy according to the augmented regimen. If these patients have received interim maintenance II chemotherapy with escalating IV methotrexate, they receive delayed intensification II chemotherapy according to the augmented regimen. These patients also receive cranial irradiation starting on day 28 of delayed intensification II chemotherapy and then proceed to maintenance therapy.

Beginning on day 56 of interim maintenance II chemotherapy, patients receive delayed intensification II chemotherapy as in delayed intensification I chemotherapy.

Beginning on day 56 of delayed intensification II chemotherapy, patients receive maintenance chemotherapy comprising oral DM twice daily on days 0-4, 28-32, and 56-60; VCR IV on days 0, 28, and 56; oral MP on days 0-83; oral MTX on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; and MTX IT on day 0.

Patients are followed every 4-8 weeks for one year, every 3 months for one year, every 6 months for one year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,037 randomized patients will be accrued for this study within 3.75 years.

Ages Eligible for Study:  1 Year   -   9 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of previously untreated B-cell precursor acute lymphoblastic leukemia
• More than 25% L1 or L2 lymphoblasts
• No more than 25% L3 lymphoblasts
• WBC < 50,000/mm^3
• No T-cell precursor acute lymphoblastic leukemia by immunophenotyping
• Massive lymphadenopathy, massive splenomegaly, or large mediastinal mass allowed
• CNS or testicular leukemia allowed
• No patients found to have t(8;14)(q24;q32), t(8;22)(q24;q11), and t(2;8)(p11-p12;q24) (characteristic of Burkitt's lymphoma)

PATIENT CHARACTERISTICS: Age:

• 1 to 9

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No more than 72 hours since prior intrathecal cytarabine

Endocrine therapy:

• At least 30 days since prior systemic corticosteroids given for more than 48 hours
• Prior corticosteroids for mediastinal mass causing superior mediastinal syndrome allowed
• Prior or concurrent inhaled corticosteroids allowed

Radiotherapy:

• Prior radiotherapy for mediastinal mass causing superior mediastinal syndrome allowed
• No concurrent spinal radiotherapy

Surgery:

• Not specified

Arizona
      Phoenix Children's Hospital, Phoenix,  Arizona,  85016,  United States; Recruiting
California
      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
      Children's Hospital and Research Center at Oakland, Oakland,  California,  94609-1809,  United States; Recruiting
      Children's Hospital Central California, Madera,  California,  93638-8762,  United States; Recruiting
      Children's Hospital Los Angeles, Los Angeles,  California,  90027-0700,  United States; Recruiting
      Children's Hospital of Orange County, Orange,  California,  92868,  United States; Recruiting
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
      General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States; Recruiting
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting
      Kaiser Permanente Medical Center - Sacramento, Sacramento,  California,  95825,  United States; Recruiting
      Kaiser Permanente Medical Center - Santa Clara, Santa Clara,  California,  95051-5386,  United States; Recruiting
      Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego,  California,  92120,  United States; Recruiting
      Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States; Recruiting
      Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
      Santa Barbara Cottage Hospital, Santa Barbara,  California,  93102,  United States; Recruiting
      Southern California Permanente Medical Group, Downey,  California,  90242,  United States; Recruiting
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143,  United States; Recruiting
Colorado
      Children's Hospital Cancer Center, Denver,  Colorado,  80218,  United States; Recruiting
      Presbyterian - St. Luke's Medical Center, Denver,  Colorado,  80218,  United States; Recruiting
Connecticut
      Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington,  Connecticut,  06360-7106,  United States; Recruiting
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8064,  United States; Recruiting
Delaware
      Alfred I. duPont Hospital for Children, Wilmington,  Delaware,  19899,  United States; Recruiting
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States; Recruiting
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Georgia
      AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta,  Georgia,  30342,  United States; Recruiting
      Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah,  Georgia,  31405,  United States; Recruiting
      Medical Center of Central Georgia, Macon,  Georgia,  31201,  United States; Recruiting
Idaho
      Mountain States Tumor Institute - Boise, Boise,  Idaho,  83712,  United States; Recruiting
Illinois
      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068-1174,  United States; Recruiting
      Southern Illinois University School of Medicine, Springfield,  Illinois,  62794-9658,  United States; Recruiting
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60601,  United States; Recruiting
      University of Illinois Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Riley Children Cancer Center at Riley Hospital for Children, Indianapolis,  Indiana,  46202-5225,  United States; Recruiting
Iowa
      Blank Children's Hospital, Des Moines,  Iowa,  50308,  United States; Recruiting
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Kentucky
      Kosair Children's Hospital, Louisville,  Kentucky,  40202-3830,  United States; Recruiting
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0284,  United States; Recruiting
Louisiana
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Maryland
      Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore,  Maryland,  21215,  United States; Recruiting
Massachusetts
      Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield,  Massachusetts,  01107,  United States; Recruiting
Michigan
      Breslin Cancer Center at Ingham Regional Medical Center, Lansing,  Michigan,  48910,  United States; Recruiting
      Bronson Methodist Hospital, Kalamazoo,  Michigan,  49007-5364,  United States; Recruiting
      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
      DeVos Children's Hospital, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0914,  United States; Recruiting
      William Beaumont Hospital - Royal Oak, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
Minnesota
      Children's Hospitals and Clinics - Minneapolis/St. Paul, Minneapolis,  Minnesota,  55404,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
      St. Mary's - Duluth Clinic Cancer Center, Duluth,  Minnesota,  55805,  United States; Recruiting
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Missouri
      Children's Mercy Hospital, Kansas City,  Missouri,  64108,  United States; Recruiting
Nebraska
      Children's Hospital of Omaha, Omaha,  Nebraska,  68114,  United States; Recruiting
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-2168,  United States; Recruiting
Nevada
      Sunrise Hospital and Medical Center, Las Vegas,  Nevada,  89109,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States; Recruiting
      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112-2094,  United States; Recruiting
      St. Barnabas Medical Center, Livingston,  New Jersey,  07039,  United States; Recruiting
      St. Joseph's Hospital and Medical Center, Paterson,  New Jersey,  07503,  United States; Recruiting
      Valerie Fund Children's Center at Atlantic Health, Summit,  New Jersey,  07901,  United States; Recruiting
New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States; Recruiting
      Brookdale University Hospital and Medical Center, Brooklyn,  New York,  11212,  United States; Recruiting
      Brooklyn Hospital Center, Brooklyn,  New York,  11201-5493,  United States; Recruiting
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States; Recruiting
      Comprehensive Cancer Center at Maimonides Medical Center, Brooklyn,  New York,  11219,  United States; Recruiting
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11794,  United States; Recruiting
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
      New York Medical College, Valhalla,  New York,  10595,  United States; Recruiting
      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
      Schneider Children's Hospital, New Hyde Park,  New York,  11042,  United States; Recruiting
      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
      SUNY Upstate Medical University Hospital, Syracuse,  New York,  13210,  United States; Recruiting
North Carolina
      Blumenthal Cancer Center at Carolinas Medical Center, Charlotte,  North Carolina,  28232-2861,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
      Presbyterian Cancer Center at Presbyterian Hospital, Charlotte,  North Carolina,  28233,  United States; Recruiting
North Dakota
      Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo,  North Dakota,  58103-4940,  United States; Recruiting
      Meritcare Roger Maris Cancer Center, Fargo,  North Dakota,  58122,  United States; Recruiting
Ohio
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308-1062,  United States; Recruiting
      Children's Medical Center - Dayton, Dayton,  Ohio,  45404,  United States; Recruiting
      Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229-3039,  United States; Recruiting
      Columbus Children's Hospital, Columbus,  Ohio,  43205-2696,  United States; Recruiting
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States; Recruiting
      St. Vincent Mercy Medical Center, Toledo,  Ohio,  43608,  United States; Recruiting
      Toledo Children's Hospital, Toledo,  Ohio,  43601,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
      Doernbecher Children's Hospital at Oregon Health & Science University, Portland,  Oregon,  97239-3098,  United States; Recruiting
Pennsylvania
      Children's Hospital at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
      Geisinger Medical Center, Danville,  Pennsylvania,  17822-1320,  United States; Recruiting
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting
South Dakota
      Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls,  South Dakota,  57117-5039,  United States; Recruiting
Tennessee
      East Tennessee Children's Hospital, Knoxville,  Tennessee,  37901,  United States; Recruiting
      East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City,  Tennessee,  37614-0622,  United States; Recruiting
      Vanderbilt Children's Hospital, Nashville,  Tennessee,  37232-6310,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      Children's Hospital of Austin, Austin,  Texas,  78701,  United States; Recruiting
      Covenant Children's Hospital, Lubbock,  Texas,  79410,  United States; Recruiting
      MBCCOP - South Texas Pediatrics, San Antonio,  Texas,  78229-3900,  United States; Recruiting
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
      Medical City Dallas Hospital, Dallas,  Texas,  75230,  United States; Recruiting
      Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio,  Texas,  78229-3902,  United States; Recruiting
      Texas Tech University Health Sciences Center School of Medicine, Amarillo,  Texas,  79106,  United States; Recruiting
Virginia
      Children's Hospital of the King's Daughters, Norfolk,  Virginia,  23507,  United States; Recruiting
Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States; Recruiting
      Deaconess Medical Center, Spokane,  Washington,  99210-0248,  United States; Recruiting
      Group Health Central Hospital, Seattle,  Washington,  98112,  United States; Recruiting
      Mary Bridge Children's Hospital and Health Center, Tacoma,  Washington,  98415-0299,  United States; Recruiting
West Virginia
      Cabell Huntington Hospital, Huntington,  West Virginia,  25701,  United States; Recruiting
      West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston,  West Virginia,  25302,  United States; Recruiting
Wisconsin
      Bellin Memorial Hospital, Green Bay,  Wisconsin,  54301,  United States; Recruiting
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
      Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse,  Wisconsin,  54601,  United States; Recruiting
      Marshfield Clinic - Marshfield Center, Marshfield,  Wisconsin,  54449-5772,  United States; Recruiting
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States; Recruiting
Australia, New South Wales
      Sydney Children's Hospital, Randwick,  New South Wales,  2031,  Australia; Recruiting
Australia, Queensland
      Royal Children's Hospital, Brisbane,  Queensland,  4029,  Australia; Recruiting
Australia, Western Australia
      Princess Margaret Hospital for Children, Perth,  Western Australia,  6001,  Australia; Recruiting
Canada, British Columbia
      British Columbia Children's Hospital, Vancouver,  British Columbia,  V6H 3V4,  Canada; Recruiting
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting
Canada, Newfoundland and Labrador
      Janeway Children's Health and Rehabilitation Centre, St. John's,  Newfoundland and Labrador,  A1B 3V6,  Canada; Recruiting
Canada, Nova Scotia
      IWK Health Centre, Halifax,  Nova Scotia,  B3J 3G9,  Canada; Recruiting
Canada, Ontario
      Children's Hospital of Western Ontario, London,  Ontario,  N6C 2V5,  Canada; Recruiting
Canada, Saskatchewan
      Allan Blair Cancer Centre at Pasqua Hospital, Regina,  Saskatchewan,  S4T 7T1,  Canada; Recruiting
      Saskatoon Cancer Centre, Saskatoon,  Saskatchewan,  S7N 4H4,  Canada; Recruiting
New Zealand
      Starship Children's Health, Auckland,  New Zealand; Recruiting
Switzerland
      Swiss Pediatric Oncology Group Bern, Bern,  CH 3010,  Switzerland; Recruiting
      Swiss Pediatric Oncology Group Geneva, Geneva,  CH 1211,  Switzerland; Recruiting
      Swiss Pediatric Oncology Group Lausanne, Lausanne,  CH 1011,  Switzerland; Recruiting

Study chairs or principal investigators

Yousif H. Matloub, MD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067855; COG-C1991; CCG-1991; NCT00005945
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005945
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08