Monoclonal Antibody Therapy and Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Contiguous Stage II Adult Diffuse Large Cell Lymphoma; Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Grade 3 Follicular Lymphoma; Contiguous Stage II Mantle Cell Lymphoma; Contiguous Stage II Marginal Zone Lymphoma; Contiguous Stage II Small Lymphocytic Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Stage I Adult Diffuse Large Cell Lymphoma; Stage I Adult Diffuse Small Cleaved Cell Lymphoma; Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage I Grade 3 Follicular Lymphoma; Stage I Mantle Cell Lymphoma; Stage I Marginal Zone Lymphoma; Stage I Small Lymphocytic Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Small Lymphocytic Lymphoma; Waldenström Macroglobulinemia
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Large B-Cell, Diffuse; Waldenstrom Macroglobulinemia; Recurrence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This phase I trial is studying how well monoclonal antibody therapy with peripheral stem cell
      transplant works in treating patients with non-Hodgkin's lymphoma. 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. Peripheral stem cell transplant may allow the doctor to
      give higher doses of monoclonal antibodies and kill more cancer cells
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated dose of IDEC-Y2B8 when administered with rituximab in
      vivo purging and autologous stem cell rescue.

      II. To obtain correlative laboratory data of in vivo purging with rituximab in patients with
      0-35% marrow involvement.

      OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
      (IDEC-Y2B8).

      PART I: Patients receive rituximab IV on days 1, 8, 15, and 22 and cyclophosphamide IV over 1
      hour on day 25. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on day
      26 and continuing until autologous peripheral blood stem cells (PBSC) are harvested.

      PART II: Beginning 4-6 weeks after completion of the fourth rituximab infusion, patients
      receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry
      imaging on days 1, 2, 4, and 7. Patients then receive IDEC-Y2B8 IV over 10 minutes once
      between days 8-15.

      The initial 3 patients receive the same dose of IDEC-Y2B8 and then subsequent cohorts of 3-5
      patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose is
      determined.

      PART III: All patients undergo PBSC transplantation (PBSCT) beginning after residual bone
      marrow radioactivity resolves. G-CSF is administered SC beginning 1 day after PBSCT and
      continuing until blood counts recover.

      Patients are followed every 3 months for 1 year and then every 6 months thereafter.
    

Intervention name(s): rituximab; cyclophosphamide; filgrastim; yttrium Y 90 ibritumomab tiuxetan; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Biological; Radiation; Procedure
Intervention description(s): Given IV; Given IV; Given SC; Given IV; Undergo PBSCT
Other intervention name(s): IDEC-C2B8; IDEC-C2B8 monoclonal antibody; Mabthera; MOAB IDEC-C2B8; Rituxan; CPM; CTX; Cytoxan; Endoxan; Endoxana; G-CSF; Neupogen; 90Y ibritumomab tiuxetan; IDEC Y2B8; Y90 Zevalin; Y90-labeled ibritumomab tiuxetan; PBPC transplantation; PBSC transplantation; peripheral blood progenitor cell transplantation; transplantation, peripheral blood stem cell
Intervention MeSH terms: Cyclophosphamide; Rituximab; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment