S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma Grade I-III disease Cluster of differentiation antigen 20 (CD20) antigen positive Fewer than 5,000/mm^3 circulating lymphoid cells on a white blood cell (WBC) differential count Bidimensionally measurable disease Bone marrow aspiration and biopsy within the past 42 days No clinical evidence of central nervous system (CNS) involvement by lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Granulocyte count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Not specified Renal: Not specified Cardiovascular: No impaired cardiac status, including: Severe coronary artery disease Cardiomyopathy Congestive heart failure Serious arrhythmia Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram for questionable cardiac history Other: No hypersensitivity to iodine Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study participation HIV negative No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibodies for cancer Chemotherapy: No prior chemotherapy for lymphoma Prior prednisone for non-lymphoma related illnesses allowed Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for lymphoma Surgery: See Disease Characteristics
Sites / Locations
- Alaska Regional Hospital Cancer Center
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Alta Bates Summit Comprehensive Cancer Center
- Peninsula Medical Center
- Marin Cancer Institute at Marin General Hospital
- Sutter Health - Western Division Cancer Research Group
- Desert Regional Medical Center Comprehensive Cancer Center
- University of California Davis Cancer Center
- California Pacific Medical Center - California Campus
- Stanford Cancer Center
- Sutter Solano Medical Center
- Helen and Harry Gray Cancer Center at Hartford Hospital
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Center for Cancer Care and Research at Watson Clinic, LLP
- Sacred Heart Cancer Center at Sacred Heart Hospital
- West Florida Cancer Institute at West Florida Hospital - Pensacola
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Dwight David Eisenhower Army Medical Center
- Northeast Georgia Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Tripler Army Medical Center
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- University of Illinois Cancer Center
- University of Chicago Cancer Research Center
- Decatur Memorial Hospital Cancer Care Institute
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Veterans Affairs Medical Center - Hines
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Good Samaritan Regional Health Center
- Edward Hospital Cancer Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas-Independence
- Providence Medical Center
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Johnson County Radiation Therapy
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Shawnee Mission Medical Center
- Cotton-O'Neil Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas, PA - Winfield
- Greenebaum Cancer Center at University of Maryland Medical Center
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Lahey Clinic Medical Center - Burlington
- Berkshire Hematology Oncology, PC
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Holland Community Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Hackley Hospital
- Lakeland Regional Cancer Care Center - St. Joseph
- Oncology Care Associates, PLLC
- Munson Medical Center
- Metro Health Hospital
- University of Mississippi Cancer Clinic
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- Saint Francis Medical Center
- Saint Luke's Hospital
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Independence Regional Health Center
- Freeman Cancer Institute at Freeman Health System
- St. John's Regional Medical Center
- Truman Medical Center - Hospital Hill
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- Kansas City Cancer Center at St. Joseph's Medical Mall
- St. Joseph Medical Center
- North Kansas City Hospital
- Parvin Radiation Oncology
- CCOP - Kansas City
- Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
- Heartland Regional Medical Center
- Midwest Hematology Oncology Group, Incorporated
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- 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 - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- 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
- Good Samaritan Cancer Center at Good Samaritan Hospital
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Roswell Park Cancer Institute
- Tucker Center for Cancer Care at Orange Regional Medical Center
- New York Weill Cornell Cancer Center at Cornell University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Duke Comprehensive Cancer Center
- Wayne Memorial Hospital, Incorporated
- McDowell Cancer Center at Akron General Medical Center
- Mary Rutan Hospital
- Adena Regional Medical Center
- Good Samaritan Hospital Cancer Treatment Center
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- 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
- Grady Memorial Hospital
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Community Oncology Group at Cleveland Clinic Cancer Center
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- St. Rita's Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Mount Carmel St. Ann's Cancer Center
- Clinton Memorial Hospital
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- Adventist Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Legacy Meridian Park Hospital
- Roper St. Francis Cancer Center at Roper Hospital
- Hollings Cancer Center at Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- CCOP - Greenville
- Joe Arrington Cancer Research and Treatment Center
- UMC Southwest Cancer and Research Center
- Huntsman Cancer Institute at University of Utah
- Lynchburg Hematology-Oncology Clinic
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- St. Francis Hospital
- Columbia Basin Hematology
- Cascade Cancer Center at Evergreen Hospital Medical Center
- Olympic Medical Center
- Good Samaritan Cancer Center
- Valley Medical Center
- CCOP - Virginia Mason Research Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Franciscan Cancer Center at St. Joseph Medical Center
- Allenmore Hospital
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Schiffler Cancer Center at Wheeling Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I (CHOP only)
Arm II (CHOP + rituximab)
Arm III (CHOP + tositumomab)
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141.
Patients receive chemotherapy as in arm I and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141.