S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma

A regiszterben nem jelölt feltételek

• DISEASE CHARACTERISTICS:
• Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)
  • Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group
  • Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections
  • Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible
• Patients must have non-bulky stage I or II disease by Ann Arbor classification
  • This staging excludes FDG-PET evaluation
  • Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are upstaged to stage III or IV based on FDG-PET evaluation, are also eligible
• 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 may have either measurable or evaluable limited-stage DLBCL
  • Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible
  • If patient has measurable disease it must be documented on the Lymphoma Baseline Tumor Assessment Form (Form #15187)
  • All measurable disease must be assessed within 28 days prior to registration
  • Patients with non-measurable disease in addition to 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
  • PATIENT CHARACTERISTICS:
• Zubrod performance status 0-2
• Absolute neutrophil count (ANC) ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)
• 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
• Patients must not be known to be HIV-positive
• No other prior malignancy is allowed except for the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Adequately treated stage I or II cancer from which the patient is currently in complete remission
  • Any other cancer from which the patient has been disease-free for 5 years
  • PRIOR CONCURRENT THERAPY:
• Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy for lymphoma