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High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study


Phase 1
N/A
14 Years
Open (Enrolling)
Both
Childhood Germ Cell Tumor, Drug/Agent Toxicity by Tissue/Organ, Extragonadal Germ Cell Tumor, Ovarian Cancer

Thank you

Trial Information

High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study


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.

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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Neyssa M. Marina, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000066956

NCT ID:

NCT00003811

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Childhood Germ Cell Tumor
  • Drug/Agent Toxicity by Tissue/Organ
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • drug/agent toxicity by tissue/organ
  • childhood teratoma
  • childhood malignant testicular germ cell tumor
  • childhood malignant ovarian germ cell tumor
  • childhood extragonadal germ cell tumor
  • recurrent childhood malignant germ cell tumor
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Florida PediatricTampa, Florida  33682-7757
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Mount Sinai School of MedicineNew York, New York  10029
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Northern New JerseyHackensack, New Jersey  07601
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
CCOP - OchsnerNew Orleans, Louisiana  70121
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
Baptist Hospital of MiamiMiami, Florida  33176-2197
Tulane University School of MedicineNew Orleans, Louisiana  70112
CCOP - Columbia River ProgramPortland, Oregon  97213
University of Texas Medical BranchGalveston, Texas  77555-1329
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Eastern Maine Medical CenterBangor, Maine  04401
Hackensack University Medical CenterHackensack, New Jersey  07601
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
St. Mary's HospitalWest Palm Beach, Florida  33407
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Via Christi Regional Medical CenterWichita, Kansas  67214
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Schneider Children's HospitalNew Hyde Park, New York  11042
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Hope Children's HospitalOak Lawn, Illinois  60453
Mission Saint Joseph's Health SystemAsheville, North Carolina  28801
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Hospital and Health CenterSan Diego, California  92123-4282
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
MBCCOP - South Texas PediatricSan Antonio, Texas  78284-7810
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Scott and White ClinicTemple, Texas  76508
James H. Quillen College of MedicineJohnson City, Tennessee  37614-0622
Carilion Roanoke Community HospitalRoanoke, Virginia  24013
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
St. John's Hospital and Medical CenterDetroit, Michigan  48236
West Virginia University Medical School-CharlestonCharleston, West Virginia  25304