Spots Global Cancer Trial Database for Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Official Title: A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #12373) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
Study ID: NCT00117975
Conditions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, 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 more than one monoclonal antibody may be a better way to block cancer growth. PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.
Detailed Description: OBJECTIVES: Primary * Determine the overall and complete response rate in patients with previously untreated CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma treated with rituximab and galiximab. * Determine the time to disease progression in patients treated with this regimen. Secondary * Determine the toxicity profile of this regimen in these patients. * Correlate Fc receptor polymorphism profiling with response in patients treated with this regimen. OUTLINE: This is a multicenter study. * Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and galiximab IV over 1 hour on day 3, 8, 15, and 22. * Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 4 months for up to 10 years. PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Galesburg Clinic, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex, Hopedale, Illinois, United States
Kewanee Hospital, Kewanee, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
St. Margaret's Hospital, Spring Valley, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Iowa Blood and Cancer Care, Cedar Rapids, Iowa, United States
St. Luke's Hospital, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Capital Region Cancer Center, Jefferson City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri, United States
Missouri Baptist Cancer Center, St. Louis, Missouri, United States
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Elliot Regional Cancer Center, Manchester, New Hampshire, United States
Frisbie Memorial Hospital, Rochester, New Hampshire, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls, New York, United States
Long Island Jewish Medical Center, New Hyde Park, 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
CCOP - Hematology-Oncology Associates of Central New York, Syracuse, New York, United States
Community General Hospital of Greater Syracuse, Syracuse, New York, United States
CaroMont Cancer Center at Gaston Memorial Hospital, Gastonia, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Lenoir Memorial Cancer Center, Kinston, North Carolina, United States
Wilson Medical Center, Wilson, 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, Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Bon Secours St. Francis Health System, Greenville, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, 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
St. Mary's Regional Cancer Center at St. Mary's Medical Center, Huntington, West Virginia, United States
Contact Details
Name: Myron S. Czuczman, MD
Affiliation: Roswell Park Cancer Institute
Role: STUDY_CHAIR
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