S0433 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Older Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find
      cancer cells and carry cancer-killing substances to them without harming normal cells.
      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
      cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop
      the growth of cancer cells, either by killing the cells or by stopping them from dividing.
      Giving a radiolabeled monoclonal antibody together with rituximab and combination
      chemotherapy may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving iodine I 131 tositumomab together
      with rituximab and combination chemotherapy works in treating older patients with stage II,
      stage III, or stage IV B-cell non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the 2-year progression-free survival of older patients with previously
           untreated bulky stage II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma
           treated with iodine I 131 tositumomab in combination with rituximab, cyclophosphamide,
           doxorubicin, vincristine, and prednisone.

        -  Determine the response rate (partial response, complete unconfirmed response, and
           complete response) in patients treated with this regimen.

        -  Determine the 2-year progression-free survival and response rate (partial response,
           complete unconfirmed response, and complete response) in B-cell lymphoma 2 (BCL-2)
           positive patients treated with this regimen.

      OUTLINE: This is a multicenter study.

        -  Rituximab and chemotherapy: Patients receive R-CHOP comprising rituximab IV over 6
           hours; cyclophosphamide IV over 15-45 minutes; doxorubicin IV over 5-20 minutes; and
           vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5. Treatment
           repeats every 21 days for up to 6 courses in the absence of disease progression or
           unacceptable toxicity. Patients then undergo a restaging evaluation. Patients without
           progressive disease receive CHOP chemotherapy comprising cyclophosphamide, doxorubicin,
           vincristine, and prednisone as outlined above. Treatment with CHOP chemotherapy repeats
           every 21 days for 2 courses.

        -  Radiolabeled monoclonal antibody therapy: Approximately 4-8 weeks after completion of
           chemotherapy, patients receive tositumomab IV over 1 hour followed by a dosimetric dose
           of iodine I 131 tositumomab IV over 20 minutes. Patients then undergo gamma scans over a
           1-week period in order to determine the correct treatment dose of iodine I 131
           tositumomab. No more than 2 weeks after administration of the dosimetric dose, patients
           receive tositumomab IV over 1 hour followed by a treatment dose of iodine I 131
           tositumomab IV over 20 minutes.

      After completion of study treatment, patients are followed periodically for up to 5 years.

      PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 15 months.
    

Intervention name(s): rituximab; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate; tositumomab and iodine I 131 tositumomab
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Tositumomab I-131
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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