RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome.

Condition	Treatment or Intervention	Phase
Myeloid Leukemia Refractory Anemia	Drug: asparaginase  Drug: busulfan  Drug: cyclophosphamide  Drug: cytarabine  Drug: daunorubicin  Drug: dexamethasone  Drug: etoposide  Drug: filgrastim  Drug: fludarabine  Drug: hydrocortisone  Drug: idarubicin  Drug: interleukin-2  Drug: methotrexate  Drug: thioguanine  Procedure: allogeneic bone marrow transplantation  Procedure: biological response modifier therapy  Procedure: bone marrow ablation with stem cell support  Procedure: bone marrow transplantation  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: graft versus host disease prophylaxis/therapy  Procedure: interleukin therapy  Procedure: radiation therapy  Procedure: supportive care/therapy	Phase IV

Further Study Details: 

OBJECTIVES:

• Increase the remission induction rate to greater than 85% in children with untreated acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) by replacing daunorubicin (DNR) with idarubicin (IDA) in intensively timed DCTER chemotherapy (dexamethasone, cytarabine (ARA-C), thioguanine, etoposide, and daunorubicin) in the first 4 days of each course.
• Increase the remission rate further by comparing the efficacy of consolidation chemotherapy with intensively timed IDA DCTER/DCTER vs fludarabine (FAMP), ARA-C, and IDA in maintaining remission and in achieving remission in patients with M2 disease (5%-29% blasts in marrow) at the end of induction chemotherapy.
• Compare overall survival, event-free survival, and disease-free survival in patients who receive consolidation with IDA DCTER/DCTER vs FAMP, ARA-C, and IDA.
• Compare overall survival, event-free survival, and disease-free survival in patients receiving intensification with the Capizzi II regimen (high-dose ARA-C and asparaginase) vs those receiving a matched-related allogeneic bone marrow transplantation.
• Compare overall survival, event-free survival, and disease-free survival in patients treated with interleukin-2 (IL-2) vs standard follow up care after Capizzi II intensification.
• Determine whether multichannel flow cytometry detection of residual AML on a companion biologic study protocol CCG-B942 predicts outcome, and determine whether any of these treatment regimens eliminates minimal residual disease more effectively than another.
• Register all patients with MDS treated or followed at CCG institutions and capture their biologic, historical and outcome data.
• Determine, on a companion biologic study protocol CCG-B972, whether levels of IL-2 soluble receptor (sIL-2R) and absolute lymphocyte count (ALC) before, during, and after therapy correlates with outcome.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, diagnosis (acute myelogenous leukemia vs other), and response to induction (partial vs complete remission). After induction, patients with M1/M2 marrow are randomized to arm I or II. Patients in complete remission after consolidation who have an HLA-identical or 1-antigen mismatched sibling or parent donor are nonrandomly assigned to the allogeneic bone marrow transplantation (AlBMT) regimen; all others in complete remission are nonrandomly assigned to the Capizzi II regimen, then are randomly assigned to arms III or IV. Patients with refractory anemia (RA) or RA with ringed sideroblasts with indolent disease may be registered and followed. Other patients with myelodysplastic syndromes may receive 2961 chemotherapy or go directly to AlBMT. Patients with chloromas (granulocytic sarcomas) receive optional radiotherapy on arm V.

• Patients receive idarubicin IV over 30 minutes on days 0-3, cytarabine and etoposide IV continuously on days 0-3, and oral thioguanine twice a day and oral dexamethasone 3 times a day on days 0-3. Patients then begin course 2, which consists of cytarabine, etoposide, thioguanine, and dexamethasone on days 10-13, daunorubicin IV continuously on days 10-13, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 16 and continuing until blood counts recover. Patients also receive CNS prophylaxis/therapy consisting of cytarabine intrathecally (IT) on days 0 and 14 (if no CNS disease at entry) or on days 0, 5, and 7 (if CNS disease present at entry). Disease is reassessed on day 28-42. Patients with M1 or M2 marrow proceed to consolidation while those with M3 marrow or progressive disease go off study.
• Arm I: Patients receive treatment as in induction therapy, plus G-CSF SC beginning on day 16 and continuing until blood counts recover. If CSF is clear by day 10 of induction, patients receive cytarabine IT on days 0, 10, and 35. If CSF is not clear, patients receive triple intrathecal therapy (TIT; cytarabine, hydrocortisone, methotrexate) on days 0 and 10.
• Patients receive fludarabine IV over 24 hours on days 0 and 1, cytarabine IV over 72 hours on days 2-4, and idarubicin IV over 15 minutes on days 0-2. G-CSF begins on day 6 and continues until blood counts recover. Patients also receive TIT on days -1 and 7, if CSF is not clear on day 10 of induction. Patients on both arms are reassessed on day 35. Those patients with M1 marrow proceed to intensification; all others are removed from the study.
• Capizzi II regimen: Course 1: Patients receive cytarabine IV over 3 hours every 12 hours on days 0, 1, 7, and 8 and asparaginase IM on days 1 and 8. Course 2: Patients also receive cytarabine IT or TIT on days 0, 7, and 14.
• Therapy begins within 2-8 weeks of hematologic recovery. Patients may receive interim therapy consisting of oral thioguanine for about 2 weeks. Patients then receive oral busulfan every 6 hours on days -9 to -6 and cyclophosphamide IV over 1 hour on days -5 to -2. AlBMT is infused over 4 hours beginning 36-48 hours after the last dose of cyclophosphamide. Patients in complete remission after completing the Capizzi II regimen proceed to maintenance therapy on arm III.
• Arm III: Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
• Arm IV: No further treatment.
• Arm V: Patients undergo radiotherapy to the chloroma 5 days a week for 2 weeks. Patients are followed monthly for 18 months, every 3 months for 1 year, and then every 6 months until 5 years from diagnosis.

PROJECTED ACCRUAL: Approximately 880 patients with de novo acute myelogenous leukemia will be accrued for this study within 4 years. It is expected that 178 patients per year will be randomly assigned for consolidation, that 39 patients per year will undergo allogeneic bone marrow transplantation while 120 patients per year will receive chemotherapy as intensification, and that 102 patients per year will be randomly assigned for polychemotherapy immunomodulation. An additional 80 patients with myelodysplastic syndromes will be accrued for this study.

Ages Eligible for Study:  up to  21 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed previously untreated acute myeloid leukemia (AML) in patients 1 month to 21 years of age
• Infants under 1 month with progressive disease eligible
• Supportive care may be given to confirm that the leukemia is not regressing prior to entry
• No acute promyelocytic leukemia (FAB M3)
• No acute undifferentiated leukemia (FAB M0)
• Histochemical verification of AML required by the following stains:
• Wright or Giemsa
• Peroxidase
• PAS
• Chloroacetate esterase
• Sudan black
• Nonspecific esterase (NSE) with and without fluoride (NaF) inhibition
• Combined NSE/NaF and butyrate inhibition or diagnosis of megakaryoblastic leukemia (FAB M7) should be supported by one of the following:
• CD41 reactivity
• Glycoprotein 1b reactivity
• Factor VIII-related antigen reactivity
• Platelet peroxidase on electron microscopy
• The following are also eligible:
• Myelodysplastic syndromes, including:
• Refractory anemia (RA) *
• RA with ringed sideroblasts (RARS) *
• RA with excess blasts (RAEB)
• RAEB in transformation (RAEBt)
• Chronic myelomonocytic leukemia (CMML)
• AML with monosomy 7
• Granulocytic sarcoma (chloroma) with or without marrow involvement
• Mixed lineage leukemia with 2 morphologically defined populations provided the predominant population is myeloid
• No Downs syndrome
• No juvenile chronic myelogenous leukemia
• No Fanconi's anemia
• No secondary AML NOTE: * RA and RARS may be registered and observed until treatment deemed necessary

PATIENT CHARACTERISTICS: Age:

• Under 22

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoeitic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior anticancer chemotherapy

Endocrine therapy:

• Prior topical or inhaled steroids for nonmalignant conditions allowed

Radiotherapy :

• No prior anticancer radiotherapy

Surgery:

• Not specified

Other:

• No prior antileukemic therapy

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35233,  United States
      University of South Alabama Medical Center, Mobile,  Alabama,  36604,  United States
Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
      Phoenix Children's Hospital, Phoenix,  Arizona,  85016-7710,  United States
Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States
California
      Cancer Center and Beckman Research Institute, City of Hope, Duarte,  California,  91010-3000,  United States
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
      Children's Hospital Los Angeles, Los Angeles,  California,  90027-0700,  United States
      Children's Hospital and Health Center, San Diego,  California,  92123-4282,  United States
      Children's Hospital of Oakland, Oakland,  California,  94609-1809,  United States
      Children's Hospital of Orange County, Orange,  California,  92868,  United States
      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States
      Jonathan Jaques Children's Cancer Center, Long Beach,  California,  90801-1428,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Kaiser Permanente Medical Center - Santa Clara, Santa Clara,  California,  95051-5386,  United States
      Kaiser Permanente Medical Group - San Francisco, San Francisco,  California,  94115,  United States
      Kaiser Permanente-Southern California Permanente Medical Group, San Diego,  California,  92120,  United States
      Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States
      Lucile Packard Children's Hospital at Stanford, Palo Alto,  California,  94304,  United States
      Santa Barbara Cottage Hospital, Santa Barbara,  California,  93102,  United States
      Southern California Permanente Medical Group, Downey,  California,  90242,  United States
      Sutter Cancer Center, Sacramento,  California,  95816,  United States
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States
      University of California Davis Medical Center, Sacramento,  California,  95817,  United States
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92103-8447,  United States
      Children's Hospital Central California, Madera,  California,  93638-8762,  United States
Colorado
      Childhood Hematology/Oncology Associates, Denver,  Colorado,  80218,  United States
      Children's Hospital of Denver, Denver,  Colorado,  80218-1088,  United States
      Presbyterian-St Luke's Medical Center, Denver,  Colorado,  80218,  United States
Connecticut
      University of Connecticut Health Center, Farmington,  Connecticut,  06360-7106,  United States
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States
Delaware
      Alfred I. Dupont Institute, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States
      Lombardi Cancer Center, Washington,  District of Columbia,  20007,  United States
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      All Children's Hospital, St. Petersburg,  Florida,  33701,  United States
      Baptist Hospital of Miami, Miami,  Florida,  33176-2197,  United States
      Broward General Medical Center, Fort Lauderdale,  Florida,  33316,  United States
      Children's Hospital of Southwest Florida, Fort Myers,  Florida,  33908,  United States
      Joe DiMaggio Children's Hospital at Memorial, Hollywood,  Florida,  33021,  United States
      Miami Children's Hospital, Miami,  Florida,  33155-4069,  United States
      Nemours Children's Clinic, Jacksonville,  Florida,  32207,  United States
      Nemours Children's Clinic-Orlando, Orlando,  Florida,  32806,  United States
      Sacred Heart Children's Hospital, Pensacola,  Florida,  32504,  United States
      Shands Hospital and Clinics, University of Florida, Gainesville,  Florida,  32610-100277,  United States
      St. Mary's Hospital, West Palm Beach,  Florida,  33407,  United States
      Tampa Children's Hospital, Tampa,  Florida,  33677-4227,  United States
      University of Miami-Jackson Memorial Hospital, Miami,  Florida,  33136,  United States
      Florida Hospital Cancer Institute, Orlando,  Florida,  32803,  United States
Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Children's Healthcare of Atlanta - Scottish Rite, Atlanta,  Georgia,  30342,  United States
      Medical Center of Central Georgia, Macon,  Georgia,  31201,  United States
      Medical College of Georgia Comprehensive Cancer Center, Augusta,  Georgia,  30912-4000,  United States
      Memorial Health University Medical Center, Inc., Savannah,  Georgia,  31403-3089,  United States
Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States
      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States
Idaho
      Mountain States Tumor Institute, Boise,  Idaho,  83712,  United States
Illinois
      Children's Memorial Hospital, Chicago, Chicago,  Illinois,  60614,  United States
      Hope Children's Hospital, Oak Lawn,  Illinois,  60453,  United States
      Lutheran General Hospital, Park Ridge,  Illinois,  60068-1174,  United States
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      Saint Jude Midwest Affiliate, Peoria,  Illinois,  61637,  United States
      Southern Illinois University School of Medicine, Springfield,  Illinois,  62794-9658,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60601,  United States
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
      St. Vincent Hospital and Health Care Center, Indianapolis,  Indiana,  46260,  United States
Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
      Raymond Blank Memorial Hospital for Children, Des Moines,  Iowa,  50309,  United States
Kansas
      Wesley Medical Center, Wichita,  Kansas,  67214,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0284,  United States
      Kosair Children's Hospital, Louisville,  Kentucky,  40202-3830,  United States
Louisiana
      Children's Hospital of New Orleans, New Orleans,  Louisiana,  70118,  United States
      Ochsner Clinic, New Orleans,  Louisiana,  70121,  United States
      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, Scarborough,  Maine,  04074,  United States
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States
      Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201-1595,  United States
      Sinai Hospital of Baltimore, Baltimore,  Maryland,  21225,  United States
Massachusetts
      Baystate Medical Center, Springfield,  Massachusetts,  01107,  United States
      Floating Hospital for Children, Boston,  Massachusetts,  02111,  United States
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      University of Massachusetts Memorial Medical Center - University Campus, Worcester,  Massachusetts,  01655,  United States
Michigan
      Bronson Methodist Hospital, Kalamazoo,  Michigan,  49007,  United States
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
      Hurley Medical Center, Flint,  Michigan,  48503,  United States
      Michigan State University, East Lansing,  Michigan,  48824,  United States
      Mott Children's Hospital, Ann Arbor,  Michigan,  48109-0914,  United States
      Spectrum Health and DeVos Children's Hospital, Grand Rapids,  Michigan,  49503,  United States
      St. John Hospital and Medical Center, Detroit,  Michigan,  48236,  United States
      William Beaumont Hospital, Royal Oak,  Michigan,  48073-6769,  United States
Minnesota
      Children's Hospitals and Clinics - Minneapolis, Minneapolis,  Minnesota,  55404,  United States
      Children's Hospitals and Clinics of Minnesota, Saint Paul,  Minnesota,  55102,  United States
      St. Mary's/Duluth Clinic Cancer Center, Duluth,  Minnesota,  55805-1983,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      Cardinal Glennon Children's Hospital, Saint Louis,  Missouri,  63104,  United States
      Children's Mercy Hospital, Kansas City,  Missouri,  64108,  United States
      St. Louis Children's Hospital, Saint Louis,  Missouri,  63110,  United States
Nebraska
      Children's Hospital of Omaha, Omaha,  Nebraska,  68114,  United States
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-2168,  United States
Nevada
      Sunrise Hospital and Medical Center, Las Vegas,  Nevada,  89109-2306,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756-0002,  United States
New Jersey
      Atlantic Health System, Summit,  New Jersey,  07901,  United States
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08903,  United States
      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States
      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112-2094,  United States
      St. Joseph's Hospital and Medical Center, Paterson,  New Jersey,  07503,  United States
New Mexico
      University of New Mexico Cancer Research and Treatment Center, Albuquerque,  New Mexico,  87131,  United States
New York
      Brookdale University Hospital and Medical Center, Brooklyn,  New York,  11212,  United States
      Brooklyn Hospital Center, Brooklyn,  New York,  11201,  United States
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States
      Columbia Presbyterian Hospital, New York,  New York,  10032,  United States
      Maimonides Medical Center, Brooklyn,  New York,  11219,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Montefiore Medical Center, Bronx,  New York,  10467-2490,  United States
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021-4885,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      Schneider Children's Hospital, New Hyde Park,  New York,  11042,  United States
      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
      State University of New York Health Science Center at Brooklyn College of Medicine, Brooklyn,  New York,  11203,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11790-7775,  United States
      James P. Wilmot Cancer Center, Rochester,  New York,  14642,  United States
North Carolina
      Carolinas Medical Center, Charlotte,  North Carolina,  28232-2861,  United States
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1081,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      East Carolina University School of Medicine, Greenville,  North Carolina,  27858-4354,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
      Mission Saint Joseph's Health System, Asheville,  North Carolina,  28801,  United States
      Presbyterian Healthcare, Charlotte,  North Carolina,  28233-3549,  United States
North Dakota
      Dakota Cancer Institute, Fargo,  North Dakota,  58103-4940,  United States
Ohio
      Children's Hospital Medical Center - Cincinnati, Cincinnati,  Ohio,  45229-2899,  United States
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308,  United States
      Children's Hospital of Columbus, Columbus,  Ohio,  43205-2696,  United States
      Children's Medical Center - Dayton, Dayton,  Ohio,  45404,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
      Forum Health-Tod Childrens Hospital, Youngstown,  Ohio,  44501,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
      St. Vincent Mercy Medical Center, Toledo,  Ohio,  43608,  United States
      Toledo Children's Hospital, Toledo,  Ohio,  43601,  United States
Oklahoma
      Children's Hospital of Oklahoma, Oklahoma City,  Oklahoma,  73104,  United States
      Natalie Warren Bryant Cancer Center, Tulsa,  Oklahoma,  74136,  United States
Oregon
      Doernbecher Children's Hospital, Portland,  Oregon,  97201-3098,  United States
      Legacy Emanuel Hospital and Health Center, Portland,  Oregon,  97227,  United States
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States
      Geisinger Medical Center, Danville,  Pennsylvania,  17822-1320,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States
      St. Christopher's Hospital for Children, Philadelphia,  Pennsylvania,  19134-1095,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02818,  United States
South Carolina
      Palmetto Health South Carolina Cancer Center, Columbia,  South Carolina,  29203,  United States
      Children's Hospital of Greenville Hospital System, Greenville,  South Carolina,  29605,  United States
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
South Dakota
      Avera Cancer Institute, Sioux Falls,  South Dakota,  57105-1080,  United States
      Sioux Valley Hospital, Sioux Falls,  South Dakota,  57117,  United States
Tennessee
      East Tennessee Children's Hospital, Knoxville,  Tennessee,  37901,  United States
      James H. Quillen College of Medicine, Johnson City,  Tennessee,  37614-0622,  United States
      Saint Jude Children's Research Hospital, Memphis,  Tennessee,  38105-2794,  United States
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Children's Hospital of Austin, Austin,  Texas,  78701,  United States
      Cook Children's Medical Center - Fort Worth, Fort Worth,  Texas,  76104,  United States
      Covenant Children's Hospital, Lubbock,  Texas,  79410,  United States
      Medical City Dallas Hospital, Dallas,  Texas,  75230,  United States
      Methodist Health Care System, San Antonio,  Texas,  78229-3902,  United States
      San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base,  Texas,  78236-5300,  United States
      Scott and White Memorial Hospital, Temple,  Texas,  76508,  United States
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
      Texas Tech University Health Sciences Center School of Medicine, Amarillo,  Texas,  79106,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78207,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0361,  United States
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States
Vermont
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
      Carilion Roanoke Community Hospital, Roanoke,  Virginia,  24013,  United States
      Children's Hospital of the King's Daughters, Norfolk,  Virginia,  23507,  United States
      Inova Fairfax Hospital, Falls Church,  Virginia,  22042-3300,  United States
      Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
      Naval Medical Center, Portsmouth, Portsmouth,  Virginia,  23708-5100,  United States
Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States
      Deaconess Medical Center, Spokane,  Washington,  99210-0248,  United States
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States
      Group Health Cooperative of Puget Sound, Seattle,  Washington,  98112,  United States
      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States
      Mary Bridge Children's Health Center, Tacoma,  Washington,  98415-0299,  United States
West Virginia
      Cabell-Huntington Hospital, Inc, Huntington,  West Virginia,  25701,  United States
      West Virginia University - Charleston, Charleston,  West Virginia,  25302,  United States
      West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9300,  United States
Wisconsin
      Bellin Memorial Hospital, Green Bay,  Wisconsin,  54301,  United States
      Gundersen Lutheran Medical Center, La Crosse,  Wisconsin,  54601,  United States
      Marshfield Clinic, Marshfield,  Wisconsin,  54449-5772,  United States
      Midwest Children's Cancer Center, Milwaukee,  Wisconsin,  53226,  United States
      St. Vincent Hospital, Green Bay,  Wisconsin,  54307-9070,  United States
      University of Wisconsin Hospital and Clinics, Madison,  Wisconsin,  53792-0001,  United States
      CCOP - Green Bay, Green Bay,  Wisconsin,  54301,  United States
Australia, New South Wales
      Children's Hospital at Westmead, Westmead,  New South Wales,  2145,  Australia
      Sydney Children's Hospital, Randwick,  New South Wales,  2031,  Australia
Australia, Queensland
      Royal Children's Hospital, Brisbane,  Queensland,  4029,  Australia
Australia, South Australia
      Women's and Children's Hospital, North Adelaide,  South Australia,  5006,  Australia
Australia, Victoria
      Royal Children's Hospital, Parkville,  Victoria,  3052,  Australia
Australia, Western Australia
      Princess Margaret Hospital for Children, Perth,  Western Australia,  6001,  Australia
Canada, Alberta
      Alberta Children's Hospital, Calgary,  Alberta,  T2T 5C7,  Canada
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, British Columbia
      British Columbia Children's Hospital, Vancouver,  British Columbia,  V6H 3V4,  Canada
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada
Canada, Newfoundland and Labrador
      Janeway Children's Health and Rehabilitation Centre, St. John's,  Newfoundland and Labrador,  A1B 3V6,  Canada
Canada, Nova Scotia
      IWK Health Centre, Halifax,  Nova Scotia,  B3J 3G9,  Canada
Canada, Ontario
      Children's Hospital, Hamilton,  Ontario,  L8N 3Z5,  Canada
      Children's Hospital of Eastern Ontario, Ottawa,  Ontario,  K1H 8L1,  Canada
      Children's Hospital of Western Ontario, London,  Ontario,  N6C 2V5,  Canada
      Hospital for Sick Children, Toronto,  Ontario,  M5G 1X8,  Canada
Canada, Quebec
      Centre Hospitalier de L'Universite Laval, Sainte-Foy,  Quebec,  GIV 4G2,  Canada
      Hopital Sainte Justine, Montreal,  Quebec,  H3T 1C5,  Canada
      Laval University Medical Center, Sainte-Foy,  Quebec,  G1V 4G2,  Canada
      McGill University Health Center - Montreal Children's Hospital, Montreal,  Quebec,  H3H 1P3,  Canada
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada
      Saskatoon Cancer Centre, Saskatoon,  Saskatchewan,  S7N 4H4,  Canada
Netherlands
      Academisch Ziekenhuis Groningen, Groningen,  9700 RB,  Netherlands
New Zealand
      Starship Children's Hospital, Auckland,  New Zealand
Puerto Rico
      San Jorge Childrens Hospital, Santurce,  00912,  Puerto Rico
      University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan,  00936-5067,  Puerto Rico
Switzerland
      Swiss Pediatric Oncology Group Bern, Bern,  CH 3010,  Switzerland
      Swiss Pediatric Oncology Group Geneva, Geneva,  CH 1211,  Switzerland
      Swiss Pediatric Oncology Group Lausanne, Lausanne,  CH 1011,  Switzerland

Study chairs or principal investigators

Beverly J. Lange, MD,  Study Chair,  Children's Hospital of Philadelphia   

Study ID Numbers:  CDR0000064883; COG-2961; CCG-2961
Record last reviewed:  February 2003
Last Updated:  October 13, 2004
Record first received:  November 24, 2000
ClinicalTrials.gov Identifier:  NCT00002798
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08