S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: rituximab; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate; R-CHOP regimen; laboratory biomarker analysis; fludeoxyglucose F 18; selective external radiation therapy; yttrium Y 90 ibritumomab tiuxetan
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I adult diffuse large cell lymphoma; 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

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride,
      vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by
      killing the cells or by stopping them from dividing. Radiation therapy uses high-energy
      x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer
      growth in different ways. Some block the ability of cancer cells to grow and spread. Others
      find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled
      monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and
      carry cancer-killing substances to them without harming normal cells. Comparing results of
      diagnostic procedures, such as PET scan and CT scan, done before, during, and after
      chemotherapy may help doctors predict a patient's response to treatment and help plan the
      best treatment.

      PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating
      patients with limited-stage diffuse large B-cell lymphoma.
    

Eligibility criteria:

        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