Spots Global Cancer Trial Database for Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
Official Title: A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
Study ID: NCT00553501
Conditions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma. PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
Detailed Description: OBJECTIVES: Primary * To determine the response rate (overall and complete) after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular non-Hodgkin lymphoma (NHL). * To determine the time to progression after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL. Secondary * To determine the toxicity profile of epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL. * To establish whether the therapeutic effects of the combination of epratuzumab and rituximab are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone). * To determine the relationship between the change in fludeoxyglucose F 18 uptake early after epratuzumab and rituximab treatment with response rate and time to progression. OUTLINE: * Induction therapy (month 1): Patients receive epratuzumab IV over 5-30 minutes on days 1, 8, 15, and 22 and rituximab IV on days 3, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity. * Extended induction therapy (months 3, 5, 7, and 9): Patients receive epratuzumab IV over 5-30 minutes followed by rituximab IV in weeks 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity. Patients receive fludeoxyglucose F 18 (FDG) subcutaneously and undergo positron emission tomography at baseline and after induction therapy to assess the degree of FDG uptake. After completion of study treatment, patients are followed every 4 months for 2 years then every 6 months for up to 10 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kaiser Permanente Medical Office -Vandever Medical Office, San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Middlesex Hospital Cancer Center, Middletown, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States
Union Hospital Cancer Program at Union Hospital, Elkton MD, Maryland, United States
Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Oncology Care Associates, PLLC, Saint Joseph, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care, Concord, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Lakes Region General Hospital, Laconia, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
Iredell Memorial Hospital, Statesville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Mountainview Medical, Berlin, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Danville Regional Medical Center, Danville, Virginia, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center, Huntington, West Virginia, United States
Contact Details
Name: Barbara Grant, MD
Affiliation: University of Vermont
Role: STUDY_CHAIR
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