RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin , etoposide, and bleomycin plus amifostine in treating children who have malignant germ cell tumors.

Condition	Treatment or Intervention	Phase
childhood malignant testicular germ cell tumor childhood mature and immature teratomas Drug Toxicity recurrent childhood malignant germ cell tumor childhood malignant ovarian germ cell tumor childhood extragonadal malignant germ cell tumor	Procedure: supportive care  Procedure: chemotherapy  Procedure: surgery  Behavior: supportive care/therapy  Drug: chemoprotection  Procedure: conventional surgery  Drug: amifostine  Drug: bleomycin  Drug: cisplatin  Drug: etoposide	Phase I

Further Study Details: 

OBJECTIVES: I. Evaluate the early efficacy and toxicity profile of high-dose cisplatin, etoposide, bleomycin, and amifostine in children with newly diagnosed, high-risk malignant, extragonadal germ cell tumors. II. Determine whether the use of amifostine can reduce the hematologic and nonhematologic toxic effects of this combination chemotherapy in these patients when compared to similar patients treated on POG-9049/CCG-8881 with the same combination chemotherapy. III. Determine the response rate of patients treated with this regimen.

PROTOCOL OUTLINE: Patients undergo surgical biopsy or resection. Patients then receive bleomycin IV over 10 minutes on day 1 and etoposide IV over 1 hour, amifostine IV over 15 minutes, and cisplatin IV over 1 hour on days 1-5. Treatment repeats every 3-4 weeks for 4 courses in the absence of unacceptable toxicity or disease progression. Patients who have no disease after 4 courses of chemotherapy receive no further treatment. Patients who have residual disease undergo second-look surgery. After surgery, patients who still have active tumor receive 2 additional courses of chemotherapy. Those patients who still have tumor after the 2 additional courses may have a third surgery. Patients are followed every month for 6 months, every 2 months for 6 months, every 6 months for 1 year, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1.39 years.

Ages Eligible for Study:  up to  14 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed, newly diagnosed, high-risk, extracranial germ cell tumors including the following: Yolk sac carcinoma (endodermal sinus tumor); Embryonal carcinoma; Choriocarcinoma; Teratoma with mixed malignant elements (malignant teratoma) OR Malignant recurrence (stage III or IV) of previously resected stage I extracranial, extragonadal tumor
• High-risk disease defined as stage III or IV extragonadal tumors
• Measurable disease by diagnostic imaging

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: Under 15 at time of diagnosis
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count greater than 750/mm3; Platelet count greater than 75,000/mm3
• Hepatic: Not specified
• Renal: Creatinine normal OR Glomerular filtration rate at least 50% of normal

Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States
Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States
California
      Children's Hospital and Health Center, San Diego,  California,  92123-4282,  United States
      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
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States
      Sutter Cancer Center, Sacramento,  California,  95816,  United States
      University of California Davis Medical Center, Sacramento,  California,  95817,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      Baptist Hospital of Miami, Miami,  Florida,  33176-2197,  United States
      CCOP - Florida Pediatric, Tampa,  Florida,  33682-7757,  United States
      Miami Children's Hospital, Miami,  Florida,  33155,  United States
      Nemours Children's Clinic, Jacksonville,  Florida,  32207,  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
      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
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States
      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States
Illinois
      Children's Memorial Hospital, Chicago, Chicago,  Illinois,  60614,  United States
      Hope Children's 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,  61637,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States
      Via Christi Regional Medical Center, Wichita,  Kansas,  67214,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  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, Portland,  Maine,  04101,  United States
Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States
Massachusetts
      Boston Floating Hospital Infants and Children, Boston,  Massachusetts,  02111,  United States
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States
      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
      Cardinal Glennon Children's Hospital, Saint Louis,  Missouri,  63104,  United States
      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,  03756-0002,  United States
New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States
New Mexico
      University of New Mexico School of Medicine, Albuquerque,  New Mexico,  87131,  United States
New York
      Mount Sinai School of Medicine, New York,  New York,  10029,  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 Sciences Center - Stony Brook, Stony Brook,  New York,  11790-7775,  United States
      University of Rochester 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,  27157-1082,  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
      Mission Saint Joseph's Health System, Asheville,  North Carolina,  28801,  United States
      Presbyterian Healthcare, Charlotte,  North Carolina,  28233-3549,  United States
Oklahoma
      Natalie Warren Bryant Cancer Center, Tulsa,  Oklahoma,  74136,  United States
      Oklahoma Memorial Hospital, Oklahoma City,  Oklahoma,  73126-0307,  United States
Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States
      Legacy Emanuel Hospital and Health Center, Portland,  Oregon,  97227,  United States
Pennsylvania
      St. Christopher's Hospital for Children, Philadelphia,  Pennsylvania,  19134-1095,  United States
South Carolina
      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
Tennessee
      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
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Cook Children's Medical Center - Fort Worth, Fort Worth,  Texas,  76104,  United States
      MBCCOP - South Texas Pediatric, San Antonio,  Texas,  78229-3900,  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 Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0209,  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,  24029,  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,  23708-2197,  United States
Washington
      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States
West Virginia
      West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9300,  United States
      West Virginia University Medical School-Charleston, 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
Australia, Victoria
      Royal Children's Hospital, Parkville,  Victoria,  3052,  Australia
Canada, Alberta
      Alberta Children's Hospital, Calgary,  Alberta,  T2T 5C7,  Canada
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, Ontario
      Children's Hospital, Hamilton,  Ontario,  L8N 3Z5,  Canada
      Children's Hospital of Eastern Ontario, Ottawa,  Ontario,  K1H 8L1,  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
      McGill University Health Center - 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
      Swiss Pediatric Oncology Group Bern, Bern,  CH 3010,  Switzerland

Study chairs or principal investigators

Neyssa M. Marina,  Study Chair,  Pediatric Oncology Group   

Study ID Numbers:  CDR0000066956; POG-9749
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003811
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08