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Brief Title: Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Official Title: Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL)
Study ID: NCT00032019
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.
Detailed Description: OBJECTIVES: * Determine the response rate, progression-free survival, and overall survival of patients with previously untreated aggressive CD20+ B-cell diffuse large cell or immunoblastic large cell lymphoma treated with rituximab, doxorubicin, etoposide, vincristine, prednisone, and cyclophosphamide. * Determine the toxic effects of this regimen in these patients. * Correlate tumor proliferation rate (MIB-1), bcl-2 expression, and p53 overexpression with complete response rate, progression-free survival, and overall survival in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive rituximab IV on day 1; doxorubicin IV continuously, etoposide IV continuously, and vincristine IV continuously on days 1-4; oral prednisone twice daily on days 1-5; and cyclophosphamide IV on day 5. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with complete or partial response receive 2 additional courses. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 1 year.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northeast Alabama Regional Medical Center, Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, United States
Naval Medical Center - San Diego, San Diego, California, United States
Veterans Affairs Medical Center - San Diego, San Diego, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
West Suburban Center for Cancer Care, River Forest, Illinois, United States
Saint Anthony Medical Center, Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Baptist Hospital East - Louisville, Louisville, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
Barnes-Jewish Hospital, St. Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon, New Hampshire, United States
Cooper University Hospital, Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, United States
Elmhurst Hospital Center, Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital, Jamaica, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
University Hospital at State University of New York - Upstate Medical University, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
NorthEast Oncology Associates, Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Cape Fear Valley Health System, Fayetteville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, United States
New Hanover Regional Medical Center, Wilmington, North Carolina, 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
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital, Providence, Rhode Island, United States
Veterans Affairs Medical Center - Dallas, Dallas, Texas, United States
Green Mountain Oncology Group, Bennington, Vermont, United States
Vermont Cancer Center at University of Vermont, Burlington, Vermont, United States
Martha Jefferson Hospital, Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia, United States
St. Mary's Medical Center, Huntington, West Virginia, United States
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus, San Juan, , Puerto Rico
Name: Wyndham H. Wilson, MD, PhD
Affiliation: National Cancer Institute (NCI)
Role: STUDY_CHAIR