Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study

Previously untreated Stage III, IV, or bulky Stage II diffuse large B-cell NHL, which is positive for CD20; registering institution must have submitted the S0433 site contact information form and a copy of their radioactive materials license to GlaxoSmithKline and been approved by GlaxoSmithKline for this study; specimens must be available for pathology review (H&E section, paraffin block, or at least 12 unstained slides from the original diagnostic specimen); >= age 18; PS=0-2; must have bidimensionally measurable disease; must have unilateral or bilateral bone marrow aspirate and biopsy performed w/in 42 days prior to registration; must have a CT scan of the chest/abdomen and pelvis performed w/in 28 days prior to registration; must not have clinical evidence of CNS involvement by lymphoma; must not have a previous diagnosis of indolent lymphoma (histologic transformation are not eligible); must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma; serum LDH must be measured w/in 28 days prior to registration; must have < 20,000 lymphoid cells/mcL w/in 28 days prior to registration; must have a cardiac ejection fraction >= 45% by MUGA scan or an ECHO w/ no significant abnormalities w/in 42 days prior to registration; must not be HIV+ or have a history of solid organ transplantation; must not be requiring continuous supplemental oxygen therapy; no prior malignancy except basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for >= 5 years; patients of reproductive potential must agree to use an effective contraceptive method from the time of registration to 6 months after receiving the Iodine-131 anti-B1 tositumomab antibody.