RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.

Condition	Treatment or Intervention	Phase
adult soft tissue sarcoma alveolar childhood rhabdomyosarcoma childhood malignant mesenchymoma embryonal childhood rhabdomyosarcoma metastatic childhood soft tissue sarcoma previously untreated childhood rhabdomyosarcoma	Drug: cyclophosphamide  Drug: dactinomycin  Drug: filgrastim  Drug: irinotecan  Drug: pegfilgrastim  Drug: sargramostim  Drug: vincristine  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the response rate of patients with newly diagnosed high-risk metastatic stage IV/clinical group IV rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and vincristine.
• Determine the toxic effects of this regimen in these patients.
• Determine the toxic effects of this regimen when given in alternating courses with vincristine, dactinomycin, and cyclophosphamide (VAC) as continuation therapy in patients with partial or complete response.
• Determine the overall and failure-free survival of patients treated with irinotecan and vincristine followed by VAC alone or VAC alternating with vincristine and irinotecan plus radiotherapy.
• Determine the pharmacokinetics of irinotecan and vincristine in these patients.

OUTLINE:

• Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 60 minutes on days 1-5 and 8-12. Treatment repeats every 21 days for a total of 2 courses. Patients experiencing partial or complete response proceed to regimen A. Patients experiencing stable or progressive disease proceed to regimen B.
• Regimen A: Patients receive vincristine IV over 1 minute weekly on weeks 6-13, 15-19, 23-27, 29, 32-35, 38-39, and 41; dactinomycin IV over 1 minute weekly on weeks 6, 12, 23, 29, 35, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 12, 16, 19, 23, 29, 35, and 41. Patients also receive irinotecan IV over 1 hour daily, 5 days a week, on weeks 9, 10, 26, 27, 32, 33, 38, and 39 and undergo radiotherapy daily, 5 days a week, on weeks 15-22.
• Regimen B: Patients receive vincristine as in regimen A; dactinomycin IV over 1 minute weekly on weeks 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients receive radiotherapy as in regimen A. Patients who do not receive upfront window irinotecan/vincristine therapy are treated with standard therapy.
• Patients receive vincristine IV over 1 minute weekly on weeks 0-13, 15-19, 23-27, 29, 32-35, 38, and 41; dactinomycin IV over 1 minute weekly on weeks 0, 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 0, 3, 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients without evidence of intracranial extension receive radiotherapy once daily, 5 days a week, during weeks 15-22. Patients with evidence of intracranial extension, or who require emergency radiotherapy, receive radiotherapy during weeks 0-6. Dactinomycin is withheld during radiotherapy. All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) beginning 24 hours after completion of each course of chemotherapy and continuing until blood counts recover. Alternatively, patients may receive pegfilgrastim SC beginning 24-36 hours after completion of each course of chemotherapy and continuing until blood counts recover.

Patients are followed every 2 months for 1 year, every 4 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24 months.

Ages Eligible for Study:  up to  49 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma
• No metastatic embryonal tumors in patients under 10 years of age, regardless of primary site
• Metastatic tumors of parameningeal sites eligible
• Bidimensionally measurable disease
• No positive cerebrospinal fluid cytology or multiple intracranial metastases
• Patients presenting with the following are only eligible for continuation therapy and may not receive irinotecan/vincristine upfront window therapy:
• Evidence of base of skull erosion or skull metastatic disease that displaces or indents the dura, compresses the brain parenchyma, or causes evidence of cranial nerve palsy
• Tumor that touches or displaces the spinal cord
• Evidence of intracranial primary tumor extension
• Tumors that could cause potentially life-threatening complications (e.g., renal, airway) with progression due to location and/or growth rate
• Requires emergency radiotherapy
• Lab values are consistent with disseminated intravascular coagulation

PATIENT CHARACTERISTICS: Age:

• Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma patients)
• 10 to 49 (embryonal histology patients)

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics
• Absolute neutrophil count greater than 1,000/mm^3*
• Platelet count greater than 150,000/mm^3* NOTE: *Unless there is tumor involvement of bone marrow

Hepatic:

• Bilirubin less than 1.5 mg/dL
• PT, PTT, and fibrinogen less than 1.5 times upper limit of normal

Renal:

• Creatinine less than 1.2 mg/dL

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Prior steroids allowed

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy

Surgery:

• No more than 42 days since prior initial surgical procedure, including biopsy for diagnosis

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35233,  United States
      University of South Alabama Cancer Research Institute, Mobile,  Alabama,  36604,  United States
Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States
      Phoenix Children's Hospital, Phoenix,  Arizona,  85016,  United States
Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States
California
      Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States
      Children's Hospital and Health Center, San Diego, San Diego,  California,  92123-4282,  United States
      Children's Hospital and Research Center at Oakland, Oakland,  California,  94609-1809,  United States
      Children's Hospital Central California, Madera,  California,  93638-8762,  United States
      Children's Hospital Los Angeles, Los Angeles,  California,  90027-0700,  United States
      Children's Hospital of Orange County, Orange,  California,  92868,  United States
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States
      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States
      Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach,  California,  90801-1428,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Kaiser Permanente Medical Center - Sacramento, Sacramento,  California,  95825,  United States
      Kaiser Permanente Medical Center - Santa Clara, Santa Clara,  California,  95051-5386,  United States
      Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego,  California,  92120,  United States
      Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States
      Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto,  California,  94304,  United States
      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  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 Comprehensive Cancer Center, San Francisco,  California,  94115,  United States
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States
Colorado
      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 Comprehensive Cancer Center at 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 Hospital for Children, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  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
      Florida Hospital Cancer Institute, Orlando,  Florida,  32804,  United States
      Jackson Memorial Hospital, Miami,  Florida,  33136,  United States
      Joe DiMaggio Children's Hospital at Memorial, Hollywood,  Florida,  33021,  United States
      Miami Children's Hospital, Miami,  Florida,  33155,  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 Cancer Center at the University of Florida Health Science Center, Gainesville,  Florida,  32610-0296,  United States
      St. Joseph's Children's Hospital, Tampa,  Florida,  33677-4227,  United States
      St. Mary's Hospital, West Palm Beach,  Florida,  33407,  United States
Georgia
      AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta,  Georgia,  30342,  United States
      Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah,  Georgia,  31405,  United States
      MBCCOP-Medical College of Georgia Cancer Center, Augusta,  Georgia,  30912-4000,  United States
      Medical Center of Central Georgia, Macon,  Georgia,  31201,  United States
Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States
Idaho
      Mountain States Tumor Institute - Boise, Boise,  Idaho,  83712,  United States
Illinois
      Advocate Hope Children's Hospital, Oak Lawn,  Illinois,  60453,  United States
      Children's Memorial Hospital - Chicago, Chicago,  Illinois,  60614,  United States
      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068-1174,  United States
      Rush University 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 Medical Center, Chicago,  Illinois,  60612,  United States
Indiana
      Riley Children Cancer Center at Riley Hospital for Children, Indianapolis,  Indiana,  46202-5225,  United States
      St. Vincent Hospital and Health Care Center, Indianapolis,  Indiana,  46260,  United States
Iowa
      Blank Children's Hospital, Des Moines,  Iowa,  50308,  United States
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States
      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States
Kansas
      Wesley Medical Center, Wichita,  Kansas,  67214,  United States
Kentucky
      Kosair Children's Hospital, Louisville,  Kentucky,  40202-3830,  United States
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0284,  United States
Louisiana
      Children's Hospital of New Orleans, New Orleans,  Louisiana,  70118,  United States
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States
      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States
Maine
      Eastern Maine Medical Center, Bangor,  Maine,  04401,  United States
      Maine Children's Cancer Program, Scarborough,  Maine,  04074-9308,  United States
Maryland
      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201-1595,  United States
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States
      Sinai Hospital of Baltimore, Baltimore,  Maryland,  21225,  United States
Massachusetts
      Baystate Regional Cancer Program at Baystate Medical Center, Springfield,  Massachusetts,  01107,  United States
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Floating Hospital for Children, Boston,  Massachusetts,  02111,  United States
      University of Massachusetts Memorial Medical Center - University Campus, Worcester,  Massachusetts,  01655,  United States
Michigan
      Breslin Cancer Center at Ingham Regional Medical Center, Lansing,  Michigan,  48910,  United States
      Bronson Methodist Hospital, Kalamazoo,  Michigan,  49007-5364,  United States
      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States
      Hurley Medical Center, Flint,  Michigan,  48503,  United States
      Josephine Ford Cancer Center at Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
      Spectrum Health and DeVos Children's Hospital, Grand Rapids,  Michigan,  49503,  United States
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0914,  United States
      Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit,  Michigan,  48236,  United States
      William Beaumont Hospital - Royal Oak, Royal Oak,  Michigan,  48073-6769,  United States
Minnesota
      Children's Hospitals and Clinics - Minneapolis, Minneapolis,  Minnesota,  55404,  United States
      Children's Hospitals and Clinics - Minnesota, Saint Paul,  Minnesota,  55102,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
      St. Mary's - Duluth Clinic Cancer Center, Duluth,  Minnesota,  55805,  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
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-2168,  United States
Nevada
      Sunrise Hospital and Medical Center, Las Vegas,  Nevada,  89109,  United States
New Hampshire
      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States
New Jersey
      Cancer Center at Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States
      Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick,  New Jersey,  08903,  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
      Valerie Fund Children's Center at Atlantic Health, Summit,  New Jersey,  07901,  United States
New Mexico
      University of New Mexico Cancer Research and Treatment Center, Albuquerque,  New Mexico,  87131,  United States
New York
      Albert Einstein Clinical Cancer Center, Bronx,  New York,  10461,  United States
      Brookdale University Hospital and Medical Center, Brooklyn,  New York,  11212,  United States
      Brooklyn Hospital Center, Brooklyn,  New York,  11201-5493,  United States
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States
      Comprehensive Cancer Center at Maimonides Medical Center, Brooklyn,  New York,  11219,  United States
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11794,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  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 Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  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
      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States
      University Hospital at State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
North Carolina
      Blumenthal Cancer Center at 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
      Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina, Greenville,  North Carolina,  27858-4354,  United States
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States
      Mission Hospitals, Asheville,  North Carolina,  28801,  United States
      Presbyterian Healthcare, Charlotte,  North Carolina,  28233,  United States
North Dakota
      Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo,  North Dakota,  58103-4940,  United States
Ohio
      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
      Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229-3039,  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
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States
      Children's Hospital at Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States
      Natalie Warren Bryant Cancer Center, Tulsa,  Oklahoma,  74136,  United States
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States
      Doernbecher Children's Hospital at Oregon Health & Science University, Portland,  Oregon,  97239-3098,  United States
      Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland,  Oregon,  97227,  United States
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2583,  United States
      Geisinger Medical Center, Danville,  Pennsylvania,  17822-1320,  United States
      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
      St. Christopher's Hospital for Children, Philadelphia,  Pennsylvania,  19134-1095,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
South Carolina
      Children's Hospital of Greenville Hospital System, Greenville,  South Carolina,  29605,  United States
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
      Palmetto Health South Carolina Cancer Center, Columbia,  South Carolina,  29203,  United States
South Dakota
      Avera Cancer Institute, Sioux Falls,  South Dakota,  57105-1080,  United States
      Sioux Valley Hospital at University of South Dakota Medical Center, Sioux Falls,  South Dakota,  57117-5039,  United States
Tennessee
      East Tennessee Children's Hospital, Knoxville,  Tennessee,  37901,  United States
      East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City,  Tennessee,  37604,  United States
      St. Jude Children's Research Hospital, Memphis,  Tennessee,  38105-2794,  United States
      Vanderbilt Children's Hospital, Nashville,  Tennessee,  37232-6310,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States
      Center for Cancer Prevention and Care at Scott and White Clinic, Temple,  Texas,  76508,  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
      MBCCOP - South Texas Pediatrics, San Antonio,  Texas,  78229-3900,  United States
      Medical City Dallas Hospital, Dallas,  Texas,  75230,  United States
      Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio,  Texas,  78229-3902,  United States
      San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base,  Texas,  78236,  United States
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9063,  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 at University of Vermont, Burlington,  Vermont,  05401-3498,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
      Carilion Medical Center for Children, Roanoke,  Virginia,  24029,  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 at Virginia Commonwealth University, Richmond,  Virginia,  23298-0121,  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 Central Hospital, Seattle,  Washington,  98112,  United States
      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States
      Mary Bridge Children's Hospital and Health Center, Tacoma,  Washington,  98415-0299,  United States
West Virginia
      Cabell Huntington Hospital, Huntington,  West Virginia,  25701,  United States
      West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, 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
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States
      Gundersen Lutheran Cancer Center at 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 Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  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 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
      McMaster Children's Hospital at Hamilton Health Sciences, Hamilton,  Ontario,  L8N 3Z5,  Canada
Canada, Quebec
      Centre de Recherche du Centre Hospitalier de l'Universite Laval, Sainte-Foy,  Quebec,  GIV 4G2,  Canada
      Hopital Sainte Justine, Montreal,  Quebec,  H3T 1C5,  Canada
      McGill University Health Center - Montreal Children's Hospital, Montreal,  Quebec,  H3G 1A4,  Canada
Canada, Saskatchewan
      Allan Blair Cancer Centre at Pasqua Hospital, 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
      Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus, San Juan,  00936-5067,  Puerto Rico
      San Jorge Childrens Hospital, Santurce,  00912,  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

Alberto S. Pappo, MD,  Study Chair,  The Hospital for Sick Children   

Study ID Numbers:  CDR0000067154; COG-D9802; IRS-D9802; CCG-D9802; POG-D9802
Record last reviewed:  November 2004
Last Updated:  November 4, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003955
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08