Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed transformed CD20+ B-cell non-Hodgkin's lymphoma (NHL) Transformation defined as: Progression to a more aggressive diffuse lymphoma, excluding conversion to a more aggressive grade of follicular lymphoma (e.g., WHO/REAL follicular center, large, grade III NHL) 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: An increase in overall tumor size Presence of B symptoms Presence of masses that are causing ongoing clinical symptomatology 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: Bone lesions Leptomeningeal disease Ascites Pleural or pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Lesions that are situated in a previously irradiated area No expected impairment in bone marrrow reserve meeting any of the following criteria: Platelet count less than 150,000/mm^3 Hypocellular bone marrow (less than 15% cellularity) Marked reduction in bone marrow precursors of one or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid) History of failed stem cell collection 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 significant remaining malignant effusion or ascites at the time of study drug administration 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 18 and over Performance status 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Absolute neutrophil count at least 1,500/mm^3 Lymphocyte count no greater than 5,000/mm^3 Platelet count at least 150,000/mm^3 Hepatic Bilirubin no greater than 2.0 mg/dL Renal Creatinine no greater than 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study treatment HIV negative No other malignancy except nonmelanoma skin cancer unless patient has completed therapy and is considered to be at less than 30% risk of relapse No human anti-mouse antibody (HAMA) reactivity (patients with prior exposure to murine antibodies) PRIOR CONCURRENT THERAPY: Biologic therapy See Radiotherapy At least 3 weeks since prior anticancer immunotherapy (6 weeks for rituximab) and recovered More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) No prior myeloablative therapy with bone marrow transplantation or peripheral blood stem cell rescue Chemotherapy See Biologic therapy At least 3 weeks since prior anticancer chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy No concurrent systemic corticosteroids with either of the following dose schedules: No greater than 50 mg of prednisone as a single dose (or equivalent) No greater than 50 mg of prednisone per dose (or equivalent) for more than 6 doses Radiotherapy See Disease Characteristics At least 3 weeks since prior anticancer radiotherapy and recovered No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan No prior external beam radiotherapy to more than 25% of active bone marrow (involved field or regional) Surgery At least 3 weeks since prior anticancer surgery and recovered More than 4 weeks since prior major surgery (other than diagnostic surgery) Other At least 3 weeks since other prior anticancer therapy and recovered
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Providence Saint Joseph Medical Center - Burbank
- Moores UCSD Cancer Center
- Kaiser Permanente Medical Office -Vandever Medical Office
- Beebe Medical Center
- CCOP - Christiana Care Health Services
- Rush-Copley Cancer Care Center
- University of Illinois Cancer Center
- University of Chicago Cancer Research Center
- Joliet Oncology-Hematology Associates, Limited - West
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cotton-O'Neil Cancer Center
- St. Francis Comprehensive Cancer Center
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
- Union Hospital Cancer Program at Union Hospital
- Dana-Farber/Brigham and Women's Cancer Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Cancer Research Center at Boston Medical Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic Cancer Center
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Methodist Estabrook Cancer Center
- Kingsbury Center for Cancer Care at Cheshire Medical Center
- Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
- Frisbie Memorial Hospital
- Cancer Institute of New Jersey at Cooper - Voorhees
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Charles R. Wood Cancer Center at Glens Falls Hospital
- New York Weill Cornell Cancer Center at Cornell University
- Stony Brook University Cancer Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilson Medical Center
- Wake Forest University Comprehensive Cancer Center
- Case Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- St. Luke's Cancer Network at St. Luke's Hospital
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Avera Cancer Institute
- Sioux Valley Hospital and University of South Dakota Medical Center
- CCOP - Scott and White Hospital
- American Fork Hospital
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- Latter Day Saints Hospital
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- Virginia Commonwealth University Massey Cancer Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
rituximab + 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.