Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate
      cancer cells and deliver radioactive cancer-killing substances to them without harming normal
      cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation
      may be an effective treatment for non-Hodgkin's lymphoma.

      PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with
      autologous stem cell transplantation in treating older patients who have relapsed or
      refractory non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the progression-free survival of older patients with relapsed or refractory
           non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous stem
           cell transplantation.

      Secondary

        -  Determine the overall survival of patients treated with this regimen.

        -  Determine the toxicity and tolerability of this regimen in these patients.

      OUTLINE:

        -  Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24
           to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab
           IV over 1 hour on day -14 and are entered into radiation isolation until day -4.

        -  Autologous stem cell transplantation: Patients undergo autologous bone marrow or
           peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow
           transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously
           beginning on day 0 and continuing until blood counts recover.

      Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

      PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.
    

Intervention name(s): filgrastim; sargramostim; autologous bone marrow transplantation; peripheral blood stem cell transplantation; tositumomab and iodine I 131 tositumomab
Intervention type(s): Biological; Biological; Procedure; Procedure; Radiation
Intervention description(s): 5 µg/kg/day subcutaneously; 250µg/m2/d subcutaneously; autologous stem cells given via central catheter; autologous stem cells given via central catheter; given intravenously (test dose of 1.7-10 mg/kg tositumomab antibody radiolabeled with ~10 mCi I-131) or via central catheter (therapy dose of 1.7-10 mg/kg tositumomab radiolabeled with individually calculated therapy dose of I-131)
Other intervention name(s): G-CSF; GM-CSF
Intervention MeSH terms: Tositumomab I-131; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Burkitt 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