Spots Global Cancer Trial Database for Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
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Trial Identification
Brief Title: Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
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 ID: NCT00003811
Study Description
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.
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
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, 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 AFB, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics, Columbia, Missouri, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint 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
Contact Details
Name: Neyssa M. Marina, MD
Affiliation: Stanford University
Role: STUDY_CHAIR
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