Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma
Condition: Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Marginal Zone Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma; Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage I Marginal Zone Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Marginal Zone Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia; Recurrence
Intervention: pharmacological study; rituximab; dexamethasone; laboratory biomarker analysis
Intervention description: Correlative studies; Given IV; Given IV; Correlative studies
Intervention MeSH terms: Dexamethasone; Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well giving rituximab and dexamethasone
      together works in treating patients with low-grade non-Hodgkin lymphoma (NHL). 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, such as dexamethasone,
      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 dexamethasone may kill more
      cancer cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically proven CD20+ low grade B cell lymphoma including
             follicular, marginal zone, monocytoid B cell, and lymphoplasmacytoid lymphoma;
             patients may be previously untreated or in relapse

          -  Patients must have measurable disease with clearly defined margins assessed by
             physical exam with direct measurement (for cutaneous B-cell lymphomas), computed
             tomography (CT) or magnetic resonance imaging (MRI), defined as >= 20 mm with
             conventional CT or MRI or >= 10 mm using spiral CT scan

          -  Absolute neutrophil count >= 1000/mm^3

          -  Hemoglobin > 7 g/dl

          -  Platelets >= 100,000/mm^3

          -  Serum creatinine =< 2.5 mg/dl

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2x the upper
             limit of normal (ULN)

          -  Karnofsky performance score >= 70 %

          -  Patient has signed an Institutional Review Board (IRB) approved informed consent form
             that conforms to federal and institutional guidelines

        Exclusion Criteria:

          -  Patient has received rituximab therapy within 6 months of entry into protocol

          -  Patient has received systemic steroid therapy within one month of entry into protocol

          -  Patient has Intermediate or High Grade NHL, mantle cell lymphoma, chronic lymphocytic
             leukemia, or small lymphocytic lymphoma

          -  Patient is pregnant or lactating

          -  Patient is unwilling or unable to practice contraception during treatment and for one
             year thereafter

          -  Patient has active central nervous system (CNS) disease

          -  Patient has human immunodeficiency virus (HIV) disease

          -  Patient has an active infection requiring antimicrobial therapy

          -  Patient has significant heart disease, New York Heart Classification III or IV heart
             disease (III: Marked limitation of physical activity; comfortable at rest, but less
             than ordinary activity causes fatigue, or dyspnea; IV: Unable to carry on any physical
             activity without symptoms; symptoms are present even at rest; if any physical activity
             is undertaken, symptoms are increased)

          -  Patient requires supplemental oxygen

          -  Patient has a concomitant malignancy or previous malignancy within the last five
             years, with the exception of adequately treated basal or squamous cell carcinoma of
             the skin, or in situ cervical or in situ breast cancer

          -  Patients with active hepatitis B virus (HBV) infection or hepatitis, or with hepatitis
             C positive serology