Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: filgrastim; rituximab; carboplatin; cyclophosphamide; doxorubicin hydrochloride; etoposide; ifosfamide; prednisone; vincristine
Intervention description: Given subcutaneously or intravenous bolus.; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV; Taken orally; Given IV
Intervention MeSH terms: Prednisone; Cyclophosphamide; Ifosfamide; Rituximab; Carboplatin; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Podophyllotoxin; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 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 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 work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Giving rituximab together with combination chemotherapy may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with combination
      chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large
      B-cell non-Hodgkin's lymphoma.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Diffuse large B-cell non-Hodgkin's lymphoma

               -  Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease

               -  The following lymphoma types are excluded:

                    -  Primary central nervous system lymphoma

                    -  Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear
                       presence of low-grade lymphoma on histologic sections)

                    -  Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative
                       radiotherapy is usually indicated)

                    -  Immunodeficiency-related lymphoma (i.e., after organ or bone marrow
                       transplant)

          -  Measurable disease

               -  Patient must have at least one objective measurable disease site (i.e.,
                  measurable in at least 2 perpendicular parameters)

               -  Measurable disease in the liver is required if the liver is the only site of
                  lymphoma involvement

               -  Abnormal positron emission tomography scans will not constitute evaluable
                  disease, unless verified by CT scan or other appropriate imaging

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-3

          -  For patients > 50 years of age, a normal ejection fraction by ECHO or Multigated
             Acquisition Scan (MUGA) is required within 6 weeks prior to registration

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Creatinine < 2.0 mg/dL

          -  Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)

        EXCLUSION CRITERIA:

          -  Prior chemotherapy or radiation therapy for lymphoma

          -  Prior anthracyclines or platinum compounds used as systemic chemotherapy

          -  Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow

          -  Concurrent pentostatin or trastuzumab (Herceptin®)

          -  Pregnant or nursing

          -  Prior malignancy within the past 5 years unless it was in situ OR was treated with
             curative intent AND the patient has remained relapse-free

          -  HIV positive