A Phase II Study To Evaluate The Safety And Efficacy Of Zevalin (IND # BB IND 4850) Therapeutic Regimen In Patients With Transformed CD20 + B-Cell Non-Hodgkin's Lymphoma
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.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 18-24
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Overall response rate
No
Thomas C. Shea, MD
Study Chair
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
CDR0000304498
NCT00062114
April 2004
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Kaiser Permanente Medical Office -Vandever Medical Office | San Diego, California 92120 |
Beebe Medical Center | Lewes, Delaware 19958 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Frisbie Memorial Hospital | Rochester, New Hampshire 03867 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Mountainview Medical | Berlin, Vermont 05602 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston, Maine 04240 |