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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
14 Years
Open (Enrolling)
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

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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Neyssa M. Marina, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University


United States: Federal Government

Study ID:




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



Baylor College of Medicine Houston, Texas  77030
Arizona Cancer Center Tucson, Arizona  85724
Roswell Park Cancer Institute Buffalo, New York  14263
Stanford University Medical Center Stanford, California  94305-5408
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
Shands Hospital and Clinics, University of Florida Gainesville, Florida  32610-100277
Sylvester Cancer Center, University of Miami Miami, Florida  33136
CCOP - Florida Pediatric Tampa, Florida  33682-7757
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
CCOP - Wichita Wichita, Kansas  67214-3882
Children's Hospital of Michigan Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
Mount Sinai School of Medicine New York, New York  10029
Presbyterian Healthcare Charlotte, North Carolina  28233-3549
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Oklahoma Memorial Hospital Oklahoma City, Oklahoma  73126-0307
Medical City Dallas Hospital Dallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Vermont Cancer Center Burlington, Vermont  05401-3498
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
University of California San Diego Cancer Center La Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
CCOP - Ochsner New Orleans, Louisiana  70121
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Boston Floating Hospital Infants and Children Boston, Massachusetts  02111
Baptist Hospital of Miami Miami, Florida  33176-2197
Tulane University School of Medicine New Orleans, Louisiana  70112
CCOP - Columbia River Program Portland, Oregon  97213
University of Texas Medical Branch Galveston, Texas  77555-1329
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
MBCCOP - Gulf Coast Mobile, Alabama  36688
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Madigan Army Medical Center Tacoma, Washington  98431-5048
Sutter Cancer Center Sacramento, California  95816
Naval Medical Center - San Diego San Diego, California  92134-3202
Eastern Maine Medical Center Bangor, Maine  04401
Hackensack University Medical Center Hackensack, New Jersey  07601
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California  95051-5386
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
St. Mary's Hospital West Palm Beach, Florida  33407
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Via Christi Regional Medical Center Wichita, Kansas  67214
Maine Children's Cancer Program Scarborough, Maine  04074-9308
University of Missouri-Columbia Hospital and Clinics Columbia, Missouri  65212
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
Schneider Children's Hospital New Hyde Park, New York  11042
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Legacy Emanuel Hospital and Health Center Portland, Oregon  97227
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital System Greenville, South Carolina  29605
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at Stanford Palo Alto, California  94304
Hope Children's Hospital Oak Lawn, Illinois  60453
Mission Saint Joseph's Health System Asheville, North Carolina  28801
Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Saint Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Children's Hospital and Health Center San Diego, California  92123-4282
Children's Memorial Hospital, Chicago Chicago, Illinois  60614
MBCCOP - South Texas Pediatric San Antonio, Texas  78284-7810
Kaiser Permanente-Southern California Permanente Medical Group San Diego, California  92120
Scott and White Clinic Temple, Texas  76508
James H. Quillen College of Medicine Johnson City, Tennessee  37614-0622
Carilion Roanoke Community Hospital Roanoke, Virginia  24013
Walt Disney Memorial Cancer Institute Orlando, Florida  32803
University of New Mexico School of Medicine Albuquerque, New Mexico  87131
St. John's Hospital and Medical Center Detroit, Michigan  48236
West Virginia University Medical School-Charleston Charleston, West Virginia  25304