Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Condition: Anaplastic Large Cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Waldenstrom Macroglobulinemia; Lymphoma, Large-Cell, Anaplastic; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial is studying how well giving iodine I 131 tositumomab together with
      etoposide and cyclophosphamide followed by autologous stem cell transplant works in treating
      patients with relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal
      antibodies, such as iodine I 131 tositumomab, can find cancer cells and deliver radioactive
      cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,
      such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Combining a
      radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell
      transplant may kill more cancer cells
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the progression-free survival of patients receiving 131 I labeled tositumomab
      antibody, etoposide (VP-16) and cyclophosphamide (CY) followed by autologous transplantation.

      II. To examine the potential efficacy of 131 I labeled tositumomab antibody, etoposide
      (VP-16) and cyclophosphamide (CY) followed by autologous transplantation.

      SECONDARY OBJECTIVES:

      I. To assess the overall survival of patients receiving 131 I labeled tositumomab antibody,
      etoposide (VP-16) and cyclophosphamide (CY) followed by autologous transplantation.

      II. To evaluate the toxicity and tolerability of the above therapy.

      OUTLINE:

      RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab intravenously
      (IV) on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131
      tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation
      isolation until day -4.

      CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.

      AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell
      transplant on day 0.

      After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and then
      annually thereafter.
    

Intervention name(s): cyclophosphamide; etoposide; iodine I 131 tositumomab; quality-of-life assessment; peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Radiation; Procedure; Procedure
Intervention description(s): Given IV; Given IV; Given IV; Ancillary study; Undergo ASCT given via central catheter
Other intervention name(s): CPM; CTX; Cytoxan; Endoxan; Endoxana; EPEG; VP-16; VP-16-213; 131-I-anti-B1 antibody; 131-I-anti-B1 monoclonal antibody; I131-MOAB-B1; iodine I 131 MOAB anti-B1; iodine I 131 monoclonal antibody anti-B1; quality of life assessment; PBPC transplantation; PBSC transplantation; peripheral blood progenitor cell transplantation; transplantation, peripheral blood stem cell
Intervention MeSH terms: Iodine; Cadexomer iodine; Cyclophosphamide; Etoposide; Etoposide phosphate; Tositumomab I-131; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment