Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003811
Recruitment Status : Completed
First Posted : December 10, 2003
Last Update Posted : July 4, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Childhood Germ Cell Tumor Drug/Agent Toxicity by Tissue/Organ Extragonadal Germ Cell Tumor Ovarian Cancer Biological: bleomycin sulfate Drug: amifostine trihydrate Drug: cisplatin Drug: etoposide Procedure: conventional surgery Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Primary Purpose: Treatment
Official Title: High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study
Study Start Date : April 2000
Actual Primary Completion Date : October 2004
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. Feasibility from Efficacy Standpoint
    The hazard rate is constant over 1.39 years, then the probability of the occurrence of a failure within this time interval follows a Poisson distribution. The table below shows the trial feasibility probabilities associated with those failure rates. We define the probability of feasibility as the probability of observing a total of at most less than three failures in 25 patient years of follow-up.

Secondary Outcome Measures :
  1. Assessment of Reduction in Toxicity
    Descriptive statistics will be performed for nephrotoxicity, hematologic and pulmonary toxicities, and inference will be performed for ototoxicity. Frequency tables of the occurrences of toxicities by grade will be tabulated for ANC and platelets. To assess nephrotoxicity and pulmonary toxicity, descriptive statistics will be calculated for GFR and DLCO, respectively. These statistics will be compared to the corresponding summaries on the appropriate population of patients from POG 9049/CCG 8881.

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003811

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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Sutter Cancer Center
Sacramento, California, United States, 95816
University of California Davis Medical Center
Sacramento, California, United States, 95817
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
Children's Hospital and Health Center
San Diego, California, United States, 92123-4282
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051-5386
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Miami Children's Hospital
Miami, Florida, United States, 33155
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States, 32803
CCOP - Florida Pediatric
Tampa, Florida, United States, 33682-7757
St. Mary's Hospital
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Portland, Maine, United States, 04101
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
St. John's Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48503
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States, 65212
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87131
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
Mount Sinai School of Medicine
New York, New York, United States, 10029
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Saint Joseph's Health System
Asheville, North Carolina, United States, 28801
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28233-3549
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Oklahoma
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States, 73126-0307
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Tennessee
James H. Quillen College of Medicine
Johnson City, Tennessee, United States, 37614-0622
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Baylor College of Medicine
Houston, Texas, United States, 77030
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States, 78236-5300
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States, 78229-3900
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Scott and White Clinic
Temple, Texas, United States, 76508
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Carilion Roanoke Community Hospital
Roanoke, Virginia, United States, 24029
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
United States, West Virginia
West Virginia University Medical School-Charleston
Charleston, West Virginia, United States, 25304
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Centre Hospitalier de L'Universite Laval
Sainte Foy, Quebec, Canada, GIV 4G2
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
Puerto Rico
San Jorge Childrens Hospital
Santurce, Puerto Rico, 00912
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Clinique de Pediatrie
Geneva, Switzerland, 1211
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Neyssa M. Marina, MD Stanford University

Publications of Results:
Responsible Party: Children's Oncology Group Identifier: NCT00003811     History of Changes
Other Study ID Numbers: 9749
POG-9749 ( Other Identifier: Pediatric Oncology Group )
CDR0000066956 ( Other Identifier: Clinical )
First Posted: December 10, 2003    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: July 2013

Keywords provided by Children's Oncology Group:
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

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs