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| ID | Type | Description | Link |
|---|---|---|---|
| CALGB-50201 | |||
| CDR0000304498 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rituximab + yttrium Y 90 ibritumomab tiuxetan | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological |
| ||
| yttrium Y 90 ibritumomab tiuxetan |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Up to 4 years | |
| Duration of response | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (CR), unconfirmed CR, and partial response | Up to 4 years | |
| Event-free survival | Up to 4 years | |
| Time to progression |
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DISEASE CHARACTERISTICS:
Histologically confirmed transformed CD20+ B-cell non-Hodgkin's lymphoma (NHL)
Transformation defined as:
Initial large cell follicular lymphoma must progress to a diffuse large cell lymphoma
De novo transformed NHL ineligible
Requiring treatment as determined by any of the following characteristics:
Must have less than 25% bone marrow involvement with lymphoma
Must have received and either relapsed or failed to respond to prior therapy for initial low grade or follicular NHL
Must have bidimensionally measurable disease defined as:
Greater than 2 cm OR 1.5 cm if 0.5 cm slices are used during spiral CT scan
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
No known meningeal lymphoma or known parenchymal CNS lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
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
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| Name | Affiliation | Role |
|---|---|---|
| Thomas C. Shea, MD | UNC Lineberger Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
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| Radiation |
|
| Up to 4 years |
| Time to next lymphoma treatment | Up to 4 years |
| Providence Saint Joseph Medical Center - Burbank |
| Burbank |
| California |
| 91505 |
| United States |
| Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States |
| Kaiser Permanente Medical Office -Vandever Medical Office | San Diego | California | 92120 | United States |
| Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Reid Hospital & Health Care Services, Incorporated | Richmond | Indiana | 47374 | United States |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | 67401 | United States |
| Cotton-O'Neil Cancer Center | Topeka | Kansas | 66604 | United States |
| St. Francis Comprehensive Cancer Center | Topeka | Kansas | 66606 | United States |
| Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston | Maine | 04240 | United States |
| Union Hospital Cancer Program at Union Hospital | Elkton MD | Maryland | 21921 | United States |
| Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Cancer Research Center at Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Borgess Medical Center | Kalamazooaa | Michigan | 49001 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59107-5100 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Great Falls | Montana | 59405 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene | New Hampshire | 03431 | United States |
| Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Frisbie Memorial Hospital | Rochester | New Hampshire | 03867 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York | 12801 | United States |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | United States |
| Stony Brook University Cancer Center | Stony Brook | New York | 11794-8174 | United States |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | The Bronx | New York | 10466 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Wilson Medical Center | Wilson | North Carolina | 27893-3428 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem | Pennsylvania | 18015 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Latter Day Saints Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Mountainview Medical | Berlin Corners | Vermont | 05602 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C422802 | ibritumomab tiuxetan |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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