Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
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Trial Identification
Brief Title: Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
Official Title: Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin
Study ID: NCT00467051
Conditions
Study Description
Brief Summary: This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin. SECONDARY OBJECTIVES: I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the tumor bank that will aid in the identification of the biological characteristics of recurrent GCT. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arizona Medical Center-University Campus, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center, Downey, California, United States
Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
UCSF Medical Center-Parnassus, San Francisco, California, United States
Harbor-University of California at Los Angeles Medical Center, Torrance, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver, Colorado, United States
University of Connecticut, Farmington, Connecticut, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lee Memorial Health System, Fort Myers, Florida, United States
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Florida Hospital Orlando, Orlando, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States
Sacred Heart Hospital, Pensacola, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States
Saint Mary's Hospital, West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Norton Children's Hospital, Louisville, Kentucky, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Children's Hospital New Orleans, New Orleans, Louisiana, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
The Childrens Mercy Hospital, Kansas City, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
Saint Joseph's Regional Medical Center, Paterson, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Albany Medical Center, Albany, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Columbia University/Herbert Irving Cancer Center, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's Hospital, Dayton, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Penn State Children's Hospital, Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Palmetto Health Richland, Columbia, South Carolina, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Carilion Clinic Children's Hospital, Roanoke, Virginia, United States
West Virginia University Charleston Division, Charleston, West Virginia, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
University of Alberta Hospital, Edmonton, Alberta, Canada
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
San Jorge Children's Hospital, San Juan, , Puerto Rico
Contact Details
Name: Carlos Rodriguez-Galindo
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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