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Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Clinical research trials and Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors. Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors  Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors
Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors
For Condition: childhood extragonadal malignant germ cell tumor,childhood malignant testicular germ cell tumor,childhood mature and immature teratomas,extragonadal germ cell tumor,Testicular Cancer
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI),Eastern Cooperative Oncology Group,Southwest Oncology Group,Cancer and Leukemia Group B
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven poor-risk, nonseminoma germ cell tumor - Must meet 1 of the following 3 conditions: - Testis or retroperitoneal primary site without visceral metastasis but with any of the following tumor marker values: - Lactic dehydrogenase (LDH) greater than 10 times upper limit of normal (ULN) - Human chorionic gonadotropin (hCG) greater than 50,000 IU/L - Alpha-fetoprotein (AFP) greater than 10,000 ng/mL - Testis or retroperitoneal primary site with 1 or more nonpulmonary visceral metastases (regardless of tumor marker values), including the following: - Bone - Brain - Liver - Other nonpulmonary viscera (e.g., skin, spleen) - Mediastinal primary site, regardless of presence/absence of visceral metastasis or tumor marker values OR - Histologically proven intermediate-risk, nonseminoma germ cell tumor - Testis or retroperitoneal primary site with no visceral metastasis (except lung), and with any of the following tumor marker values: - LDH 3-10 times ULN - hCG 5,000-50,000 IU/L - AFP 1,000-10,000 ng/mL OR - Histologically proven intermediate-risk, seminoma germ cell tumor with 1 or more nonpulmonary visceral metastases (regardless of tumor marker values or primary site), including the following: - Bone - Brain - Liver - Other nonpulmonary visceral metastasis (e.g., skin, spleen) - Histologic confirmation may be delayed, at the discretion of the protocol chairman, until after initiation of study therapy for patients with a testicular mass and elevated AFP or hCG if medical circumstances warrant immediate treatment - Measurable or evaluable disease - Concurrent registration on protocol MSKCC-89076 (SWOG-9345) for tumor biology studies required PATIENT CHARACTERISTICS: Age: - 12 and over Sex: - Male Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - See Disease Characteristics Renal: - Creatinine no greater than ULN* OR - Creatinine clearance greater than 50 mL/min* NOTE: * Abnormal levels due to ureteral obstruction by tumor allowed at the discretion of the protocol chairman Other: - HIV negative - No other concurrent malignancy except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 30 days since prior radiotherapy except for brain metastases or documented disease progression - Recovered from the toxic effects of any prior radiotherapy Surgery: - Recovered from the effects of any recent surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMotzer, Study Chair, Memorial Sloan-Kettering Cancer Center
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Instituto de Enfermedades Neoplasicas
Lima, , 34
Peru
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
United States
Puget Sound Oncology Consortium
Seattle, Washington, 98109
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0330
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7390
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
San Juan City Hospital
San Juan, , 00936-7344
Puerto Rico
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79415
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Oregon Cancer Institute
Portland, Oregon, 97201-3098
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
John Muir Medical Center
Walnut Creek, California, 94598
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Mercy Medical Center
Des Moines, Iowa, 50314
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611-4494
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Westmead Hospital
Westmead, New South Wales, 2145
Australia
CCOP - Dayton
Dayton, Ohio, 45429
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Tuft-New England Medical Center
Boston, Massachusetts, 02111
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22901
United States
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, 68128-4157
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
St. Joseph Hospital - Orange
Orange, California, 92868
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: CDR0000063820; MSKCC-94076,CLB-99812,E-3894,SWOG-9442,NCI-T94-0086D
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002596
Other Testicular Cancer Studies:
1. Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
2. Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
3. Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors
4. Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors
5. Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
Related Studies:
Other Testicular Cancer Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors
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