PET-Directed Therapy in Treating Patients with Limited-Stage Diffuse Large B-Cell Lymphoma

Inclusion Criteria

• Patients must have biopsy-proven de-novo diffuse large B-cell lymphoma (DLBCL) * Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible * Patients with prior or simultaneous diagnosis of indolent lymphoma are not eligible * Post-transplant lymphoproliferative disorder with DLBCL morphology is ineligible
• Patients must have non-bulky stage I or II disease by Ann Arbor classification * This staging excludes fludeoxyglucose F 18 (FDG)-PET evaluation * Patients who have stage I or II non-bulky disease based on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible * Stage and bulk are assigned using measurements obtained prior to biopsy
• Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration * Low-resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol * If a patient has an allergy to CT contrast, then a non-enhanced CT will be acceptable
• Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma * Any laboratory or radiographic tests performed to assess CNS involvement must be negative and must be performed within 42 days prior to registration
• Patients must have either measurable or evaluable limited-stage DLBCL * Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible; NOTE: if patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form * All measurable disease must be assessed within 28 days prior to registration * Patients with non-measurable disease with or without measurable disease must have all non-measurable disease assessed within 42 days prior to registration
• Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration
• Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group
• Patients must be offered the opportunity to consent to the use of specimens for future research
• The lymphoma must express the cluster of differentiation (CD)20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections; a report providing confirmation of CD20 expression must be submitted
• Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
• Patients must have a complete history and physical examination within 28 days prior to registration
• Zubrod performance status 0-2
• The following tests must be performed within 42 days prior to registration either for diagnosis/staging or to obtain baseline values: * White blood cells (WBC) * Hemoglobin * Lactate dehydrogenase (LDH) * Hepatitis B-surface antigen (Ag) and anti-core antibody (Ab)
• Serum creatinine =< 2 x institutional upper limit of normal (IULN), unless due to lymphoma, within 42 day prior to registration
• Patients must have aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x IULN, unless due to lymphoma, within 42 days prior to registration
• Platelet count >= 100,000 cells/mcL
• Absolute neutrophil count (ANC) >= 1,000 cells/mcL within 42 days prior to registration
• Total bilirubin =< 2 x institutional upper limit of normal (IULN) (unless due to Gilbert syndrome) within 42 days prior to registration
• Patients must have a cardiac ejection fraction >= institutional lower limit of normal (ILLN) by multi gated acquisition (MUGA) scan or 2-dimensional (D) echocardiogram (ECHO) within 42 days prior to registration
• Patients must not be known to be human immunodeficiency virus (HIV)-positive
• No other prior malignancy is allowed except for the following: * Adequately treated in situ cancers (stage 0) * Adequately treated basal cell or squamous cell skin cancer * Adequately treated stage I or II cancer from which the patient has been in complete remission or * Any other cancer from which the patient has been disease-free for at least 5 years
• Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period; a woman is considered to be "of reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
• SECOND REGISTRATION (STEP 2)
• Patients must have completed 3 cycles of R-CHOP with no evidence of disease progression
• Interim PET/CT scans must have been submitted for centralized review
• If PET-negative based on the returned results from centralized review, patients must be planning to begin further treatment within 35 days of the start of cycle 3 of R-CHOP; if PET-positive based on the returned results from centralized review, it is important for patients to start IFRT as soon as possible after the end of cycle 3 of R-CHOP; they should be planning to initiate IFRT followed by yttrium-90 ibritumomab tiuxetan within 35 days of the start of cycle 3 of R-CHOP