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
Intervention: rituximab; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate; tositumomab and iodine I 131 tositumomab
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Tositumomab I-131
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of diffuse large B-cell non-Hodgkin's lymphoma, meeting 1 of the following
             stage criteria:

               -  Bulky stage II disease

               -  Stage III disease

               -  Stage IV disease

          -  Confirmed cluster of differentiation antigen 20 (CD20) antigen-positive disease

          -  Bidimensionally measurable disease

          -  Less than 20,000/mcL circulating lymphoid cells on white blood cell (WBC) differential
             count

          -  Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original
             diagnostic specimen available

               -  Needle aspiration or cytology are not considered adequate

          -  No clinical evidence of central nervous system (CNS) involvement by lymphoma

          -  No prior diagnosis of indolent lymphoma

               -  No histologic transformation

        PATIENT CHARACTERISTICS:

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  See Disease Characteristics

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Cardiovascular

          -  Ejection fraction ≥ 45% by multiple gated acquisition scan (MUGA) OR

          -  No significant abnormalities by echocardiogram

        Pulmonary

          -  No requirement for continuous supplemental oxygen

        Other

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study treatment

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in
             situ of the cervix

          -  No known HIV positivity

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior antibody therapy for lymphoma

        Chemotherapy

          -  No prior chemotherapy for lymphoma

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy for lymphoma

        Surgery

          -  No prior solid organ transplantation

        Other

          -  Concurrent enrollment on protocol SWOG-8947 (lymphoma serum repository) or protocol
             SWOG-8819 (lymphoma tissue repository) is encouraged