Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors
- Conditions
- Childhood Germ Cell TumorExtragonadal Germ Cell TumorTesticular Germ Cell Tumor
- Registration Number
- NCT00002596
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.
- Detailed Description
OBJECTIVES:
* Compare the efficacy of bleomycin, etoposide, and cisplatin (BEP) with or without high-dose carboplatin, etoposide, and cyclophosphamide plus autologous bone marrow or peripheral blood stem cell transplantation in male patients with poor- or intermediate-risk germ cell tumors.
* Compare the toxicity of these regimens in these patients.
* Compare prospectively the prognosis in terms of the rate of decline of the serum tumor markers, human chorionic gonadotropin (hCG) and alpha-fetoprotein (AFP), in patients treated with these regimens.
* Correlate hCG and AFP with complete response and survival in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and risk status (poor vs intermediate). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive bleomycin IV on days 1, 8, and 15 and etoposide (VP-16) IV over 30-60 minutes and cisplatin (CDDP) IV over 30-60 minutes on days 1-5 (BEP). Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-16 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. G-CSF is discontinued 24 hours before initiating subsequent courses of chemotherapy, and withheld on days of bleomycin administration.
* Arm II: Patients receive 2 courses of BEP and G-CSF as in arm I. Patients who have no marrow involvement with tumor undergo harvest of autologous bone marrow before the first or second course of BEP. Patients who have bone marrow involvement with tumor undergo harvest of G-CSF-mobilized autologous peripheral blood stem cells (PBSC) on days 17-21 of the first and/or second courses of BEP. When blood counts recover, patients receive high-dose intensification comprising carboplatin IV over 1 hour, VP-16 IV over 30-60 minutes, and cyclophosphamide IV over 1 hour on days -5 to -3. Autologous bone marrow or PBSC are reinfused over 15-20 minutes on day 0. G-CSF is administered SC beginning 24 hours after transplantation and continuing until blood counts recover. Beginning 1-3 weeks after hospital discharge for the first transplantation and after recovery from any toxic effects, patients with a Karnofsky performance status of 70-100% receive a second course of high-dose intensification plus a second bone marrow or PBSC transplantation in the absence of disease progression or unacceptable toxicity.
Patients on both arms with brain metastases at presentation undergo radiotherapy and/or surgery concurrently with BEP, if medically indicated.
Patients with normal alpha fetoprotein (AFP) and human chorionic gonadotropin (hCG) tumor marker levels after completion of treatment on arm I or II undergo surgical resection of all residual masses. Patients who have no residual malignant tumor or undergo complete resection of only a mature teratoma receive no further therapy. Patients on arm I who undergo complete resection of residual malignant tumor receive 2 additional courses of VP-16 and CDDP without bleomycin. Patients on arm II who undergo complete resection of residual malignant tumor receive no additional chemotherapy. Patients with an unresectable residual malignant tumor receive additional therapy at the discretion of the treating physician. Patients with residual tumor marker (AFP and hCG) positivity after treatment on arm I or II undergo resection of residual masses if tumor marker values fall to normal by marker half-life.
PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this study within 4.4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 270
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (153)
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Tuft-New England Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mercy Medical Center
🇺🇸Des Moines, Iowa, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Veterans Affairs Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Oregon Cancer Institute
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
🇺🇸West Palm Beach, Florida, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Memorial Regional Hospital Comprehensive Cancer Center
🇺🇸Hollywood, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Ministry Medical Group - Northern Region
🇺🇸Rhinelander, Wisconsin, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
St. Joseph Hospital - Orange
🇺🇸Orange, California, United States
John Muir Medical Center
🇺🇸Walnut Creek, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Instituto de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Alegent Health-Midlands Community Hospital
🇺🇸Papillion, Nebraska, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
San Juan City Hospital
🇵🇷San Juan, Puerto Rico
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Danville Radiation Therapy Center
🇺🇸Memphis, Tennessee, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States