Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
NCT ID: NCT00003811
Last Updated: 2013-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2000-04-30
2007-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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bleomycin sulfate
amifostine trihydrate
cisplatin
etoposide
conventional surgery
Eligibility Criteria
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Inclusion Criteria
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
14 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Neyssa M. Marina, MD
Role: STUDY_CHAIR
Stanford University
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
MBCCOP - Gulf Coast
Mobile, Alabama, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Children's Hospital and Health Center
San Diego, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Stanford University Medical Center
Stanford, California, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States
CCOP - Florida Pediatric
Tampa, Florida, United States
St. Mary's Hospital
West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
Hope Children's Hospital
Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children's Cancer Program
Portland, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
St. John's Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Mission Saint Joseph's Health System
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States
James H. Quillen College of Medicine
Johnson City, Tennessee, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott and White Clinic
Temple, Texas, United States
Vermont Cancer Center
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Carilion Roanoke Community Hospital
Roanoke, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University Medical School-Charleston
Charleston, West Virginia, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Royal Children's Hospital
Parkville, Victoria, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, Canada
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
San Jorge Childrens Hospital
Santurce, , Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern, , Switzerland
Clinique de Pediatrie
Geneva, , Switzerland
Countries
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References
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Marina N, Chang KW, Malogolowkin M, London WB, Frazier AL, Womer RB, Rescorla F, Billmire DF, Davis MM, Perlman EJ, Giller R, Lauer SJ, Olson TA; Children's Oncology Group. Amifostine does not protect against the ototoxicity of high-dose cisplatin combined with etoposide and bleomycin in pediatric germ-cell tumors: a Children's Oncology Group study. Cancer. 2005 Aug 15;104(4):841-7. doi: 10.1002/cncr.21218.
Other Identifiers
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POG-9749
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066956
Identifier Type: OTHER
Identifier Source: secondary_id
9749
Identifier Type: -
Identifier Source: org_study_id
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