Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: epratuzumab; rituximab; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Epratuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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: Monoclonal antibodies, such as epratuzumab and 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. Drugs used in
      chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill
      more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal
      antibody therapy together with combination chemotherapy works in treating patients with stage
      II, stage III, or stage IV diffuse large B-cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diffuse large B-cell lymphoma

               -  B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow
                  cytometry

               -  Stage II, III, or IV disease

          -  CD22+ tumor by IHC*

        NOTE: *CD22 status may be determined after study enrollment

          -  Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam

          -  No relapsed or refractory non-Hodgkin's lymphoma

          -  No history of transformed lymphoma

          -  No CNS lymphoma

               -  CNS symptoms or bone marrow or sinus involvement must have absence of CNS
                  lymphoma confirmed by lumbar puncture

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3

             - For patients with ECOG PS 3, the PS must be disease related

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be
             within normal limits)

          -  AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)

          -  Creatinine ≤ 2 times ULN

          -  Life expectancy ≥ 12 weeks

          -  Negative pregnancy test

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 12 months after
             completion of study treatment

          -  No active serious infection requiring antibiotics

          -  No New York Heart Association class III or IV heart disease

          -  No other primary malignancy within the past 5 years, except for squamous cell or basal
             cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated
             prostate cancer with a stable prostate-specific antigen

          -  No known HIV positivity

          -  No known hepatitis B or C infection

          -  Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history
             of heart disease or is ≥ 50 years old)

          -  Willing to provide blood and tissue samples for mandatory translational research
             component of study

        PRIOR CONCURRENT THERAPY:

          -  No prior therapy for diffuse large B-cell lymphoma, including the following:

               -  Chemotherapy

               -  Immunotherapy

               -  Biologic therapy

               -  Radiotherapy

          -  Prior short course (≤ 14 days) of corticosteroids allowed

          -  Prior splenectomy allowed

          -  No prior pelvic irradiation

          -  No other concurrent investigational agents

          -  No concurrent chemotherapy, immunotherapy, or radiotherapy

          -  No concurrent enrollment on another treatment study involving a pharmacologic agent
             (e.g., drugs, biologics, immunotherapy, or gene therapy)