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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Southwest Oncology Group Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062114 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | 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 |
| Estimated Enrollment: | 84 |
| Study Start Date: | April 2004 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transformed CD20+ B-cell non-Hodgkin's lymphoma (NHL)
Transformation defined as:
Requiring treatment as determined by any of the following characteristics:
Must have bidimensionally measurable disease defined as:
Nonmeasurable disease includes any of the following:
No expected impairment in bone marrrow reserve meeting any of the following criteria:
Patients with peritoneal invasion and/or ascites with positive cytology for lymphoma OR pleural invasion and/or effusion with positive cytology for lymphoma are eligible only if their effusion or ascites can be tapped dry
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent systemic corticosteroids with either of the following dose schedules:
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Kaiser Permanente Medical Office -Vandever Medical Office | |
| San Diego, California, United States, 92120 | |
| Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Providence Saint Joseph Medical Center - Burbank | |
| Burbank, California, United States, 91505 | |
| United States, Delaware | |
| Beebe Medical Center | |
| Lewes, Delaware, United States, 19958 | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, Illinois | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| University of Illinois Cancer Center | |
| Chicago, Illinois, United States, 60612-7243 | |
| United States, Indiana | |
| Reid Hospital & Health Care Services, Incorporated | |
| Richmond, Indiana, United States, 47374 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Kansas | |
| Cotton-O'Neil Cancer Center | |
| Topeka, Kansas, United States, 66604 | |
| St. Francis Comprehensive Cancer Center | |
| Topeka, Kansas, United States, 66606 | |
| Tammy Walker Cancer Center at Salina Regional Health Center | |
| Salina, Kansas, United States, 67401 | |
| United States, Maine | |
| Central Maine Comprehensive Cancer Center at Central Maine Medical Center | |
| Lewiston, Maine, United States, 04240 | |
| United States, Maryland | |
| Union Hospital Cancer Program at Union Hospital | |
| Elkton MD, Maryland, United States, 21921 | |
| United States, Massachusetts | |
| Cancer Research Center at Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Dana-Farber/Brigham and Women's Cancer Center | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65802 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Montana | |
| Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107-5100 | |
| Bozeman Deaconess Cancer Center | |
| Bozeman, Montana, United States, 59715 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| St. Vincent Healthcare Cancer Care Services | |
| Billings, Montana, United States, 59101 | |
| Guardian Oncology and Center for Wellness | |
| Missoula, Montana, United States, 59804 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Kalispell Medical Oncology at KRMC | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Great Falls, Montana, United States, 59405 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59807 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59807-7877 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| St. James Healthcare Cancer Care | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Great Falls Clinic - Main Facility | |
| Great Falls, Montana, United States, 59405 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Hampshire | |
| Frisbie Memorial Hospital | |
| Rochester, New Hampshire, United States, 03867 | |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | |
| Keene, New Hampshire, United States, 03431 | |
| Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Charles R. Wood Cancer Center at Glens Falls Hospital | |
| Glens Falls, New York, United States, 12801 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | |
| Bronx, New York, United States, 10466 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-8174 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wayne Radiation Oncology | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wilson Medical Center | |
| Wilson, North Carolina, United States, 27893-3428 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, Pennsylvania | |
| St. Luke's Cancer Network at St. Luke's Hospital | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| United States, South Carolina | |
| AnMed Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| American Fork Hospital | |
| American Fork, Utah, United States, 84003 | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center - East Campus | |
| Saint George, Utah, United States, 84770 | |
| Latter Day Saints Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| Logan Regional Hospital | |
| Logan, Utah, United States, 84321 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| Utah Cancer Specialists at UCS Cancer Center | |
| Salt Lake City, Utah, United States, 84106 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| Mountainview Medical | |
| Berlin, Vermont, United States, 05602 | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, Wyoming | |
| Welch Cancer Center at Sheridan Memorial Hospital | |
| Sheridan, Wyoming, United States, 82801 | |
| Study Chair: | Thomas C. Shea, MD | UNC Lineberger Comprehensive Cancer Center |
| Study Chair: | Fay Young, MD | James P. Wilmot Cancer Center |
| Study Chair: | Andrew M. Evens, DO, MS | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000304498, CALGB-50201, SWOG-C50201, ECOG-C50201 |
| Study First Received: | June 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00062114 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult immunoblastic large cell lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |