Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: rituximabRadiation: yttrium Y 90 ibritumomab tiuxetan
- Registration Number
- NCT00062114
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with progressive non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the efficacy of yttrium Y 90 ibritumomab tiuxetan and rituximab, in terms of overall response rate (complete, unconfirmed complete, and partial) and duration of response, in patients with transformed CD20+ B-cell non-Hodgkin's lymphoma.
* Determine the safety of this regimen in these patients.
* Determine the event-free survival and time to treatment progression in patients treated with this regimen.
* Determine the immunogenicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV followed within 4 hours by indium In 111 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description rituximab + yttrium Y 90 ibritumomab tiuxetan yttrium Y 90 ibritumomab tiuxetan Patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years. rituximab + yttrium Y 90 ibritumomab tiuxetan rituximab Patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
- Primary Outcome Measures
Name Time Method Duration of response Up to 4 years Overall response rate Up to 4 years
- Secondary Outcome Measures
Name Time Method Event-free survival Up to 4 years Time to progression Up to 4 years Time to next lymphoma treatment Up to 4 years Complete response (CR), unconfirmed CR, and partial response Up to 4 years
Trial Locations
- Locations (93)
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton MD, Maryland, United States
Borgess Medical Center
🇺🇸Kalamazooaa, Michigan, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, 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
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Frisbie Memorial Hospital
🇺🇸Rochester, New Hampshire, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Mountainview Medical
🇺🇸Berlin, Vermont, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Dana-Farber/Brigham and Women's Cancer Center
🇺🇸Boston, Massachusetts, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Stony Brook University Cancer Center
🇺🇸Stony Brook, New York, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
🇺🇸Lewiston, Maine, United States
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Kaiser Permanente Medical Office -Vandever Medical Office
🇺🇸San Diego, California, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Wilson Medical Center
🇺🇸Wilson, North Carolina, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
St. Francis Comprehensive Cancer Center
🇺🇸Topeka, Kansas, United States
Cotton-O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Wayne Radiation Oncology
🇺🇸Goldsboro, North Carolina, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
St. Luke's Cancer Network at St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States