S0433 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Older Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of diffuse large B-cell non-Hodgkin's lymphoma, meeting 1 of the following stage criteria: Bulky stage II disease Stage III disease Stage IV disease Confirmed cluster of differentiation antigen 20 (CD20) antigen-positive disease Bidimensionally measurable disease Less than 20,000/mcL circulating lymphoid cells on white blood cell (WBC) differential count Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original diagnostic specimen available Needle aspiration or cytology are not considered adequate No clinical evidence of central nervous system (CNS) involvement by lymphoma No prior diagnosis of indolent lymphoma No histologic transformation PATIENT CHARACTERISTICS: Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Not specified Renal Not specified Cardiovascular Ejection fraction ≥ 45% by multiple gated acquisition scan (MUGA) OR No significant abnormalities by echocardiogram Pulmonary No requirement for continuous supplemental oxygen Other Fertile patients must use effective contraception during and for 6 months after completion of study treatment No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of the cervix No known HIV positivity PRIOR CONCURRENT THERAPY: Biologic therapy No prior antibody therapy for lymphoma Chemotherapy No prior chemotherapy for lymphoma Endocrine therapy Not specified Radiotherapy No prior radiotherapy for lymphoma Surgery No prior solid organ transplantation Other Concurrent enrollment on protocol SWOG-8947 (lymphoma serum repository) or protocol SWOG-8819 (lymphoma tissue repository) is encouraged
Sites / Locations
- Alaska Regional Hospital Cancer Center
- Arizona Cancer Center at University of Arizona Health Sciences Center
- City of Hope Comprehensive Cancer Center
- 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
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Cancer Center - Medical Oncology
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Good Samaritan Regional Health Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services
- Cotton-O'Neil Cancer Center
- University of Michigan Comprehensive Cancer Center
- Saint Francis Medical Center
- Midwest Hematology Oncology Group, Incorporated
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- 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
- Northern Montana Hospital
- 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
- Falck Cancer Center at Arnot Ogden Medical Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Rutherford Hospital
- Cleveland Clinic Taussig Cancer Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center
- Charles F. Kettering Memorial Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Clinton Memorial Hospital
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- 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
- Evergreen Hematology and Oncology, PS
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
R-CHOP x 8 with I-131 Tositumomab
Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 cycles Unlabeled Anti-B1 Antibody 450 mg IV Day 170 Dosimetric dose 35 mg IV Day 170 Unlabeled Anti-B1 Antibody 450 mg IV Day 177 Therapeutic dose 35 mg IV Day 177