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Spots Global Cancer Trial Database for Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

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Trial Identification

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

Conditions

Lymphoma

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Wyndham H. Wilson, MD, PhD

Affiliation: National Cancer Institute (NCI)

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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