Spots Global Cancer Trial Database for Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
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Trial Identification
Brief Title: Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
Official Title: Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia
Study ID: NCT00039130
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.
Detailed Description: OBJECTIVES: * Determine the complete response rate in patients with previously untreated Burkitt's lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy with filgrastim (G-CSF) support. * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the feasibility and toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia vs lymphoma). * Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and oral prednisone on days 1-7. Allopurinol PO will be given on days 1-14. * Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours on days 4 and 5 and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2, patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4 and 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood counts recover. * Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5; oral dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and rituximab IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and 6. After course 3, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study within 3 years.
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Naval Medical Center - San Diego, San Diego, California, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, 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
Fort Wayne Medical Oncology and Hematology, Fort Wayne, 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
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Union Hospital Cancer Program at Union Hospital, Elkton, Maryland, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 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
Roswell Park Cancer Institute, Buffalo, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System, Lake Success, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, 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
Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, United States
Miriam Hospital, Providence, Rhode Island, United States
Mountainview Medical, Berlin, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: David Rizzieri, MD
Affiliation: Duke University Medical Center Bone Marrow Transplant
Role: STUDY_CHAIR
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