Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Filgrastim; Pegfilgrastim; Rituximab; Cyclophosphamide; Pegylated liposomal doxorubicin hydrochloride; Prednisone; Vincristine Sulfate
Intervention description: 5 mcg/kg, SC daily, start 24 hours after chemotherapy; 6 mg SC one time (24 hours after chemotherapy); 375 mg/m^2 intravenous piggy back (IVPB) on day 1, administered 1st; 750 mg/m^2 IVPB on day 1; 40 mg/m^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1; 40 mg/m^2 oral days 1 - 5.; 2 mg IV, day 1
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 61 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 older patients with diffuse large B-cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diffuse large B-cell lymphoma

               -  Stage II, III, or IV disease

               -  Previously untreated disease

          -  Measurable or evaluable disease

          -  No primary central nervous system (CNS) lymphoma or follicular B-cell lymphoma

        PATIENT CHARACTERISTICS:

        Age

          -  61 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count > 1,000/mm^3*

          -  Platelet count > 100,000/mm^3* NOTE: * Unless due to lymphoma-related hypersplenism or
             bone marrow infiltration

        Hepatic

          -  Bilirubin < 2 mg/dL

          -  Hepatitis B surface antigen negative

          -  Hepatitis B core antibody negative

          -  Hepatitis C Virus antibody negative

        Renal

          -  Creatinine < 2 mg/dL

        Cardiovascular

          -  left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or ple gated
             acquisition (MUGA) scan

          -  No uncontrolled hypertension or cardiac symptoms

          -  Cardiologist consultation required for patients with stage A cardiac failure or any of
             the following known heart diseases:

               -  Diastolic dysfunction

               -  Prior coronary artery bypass graft

               -  Prior percutaneous transluminal coronary angioplasty

               -  Prior stent insertion

               -  Prior radiotherapy to the chest

          -  No myocardial infarction within the past 6 months

          -  No New York Heart Association class II-IV heart failure

          -  No uncontrolled angina

          -  No severe uncontrolled ventricular arrhythmias

          -  No clinically significant pericardial disease

          -  No acute ischemic or active conduction system abnormality by electrocardiogram (EKG)

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No psychiatric illness that would preclude study compliance or giving informed consent

          -  No other major life-threatening illness that would preclude study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Cardiovascular

        Surgery

          -  See Cardiovascular