S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Intervention: rituximab; tositumomab; cyclophosphamide; doxorubicin; prednisone; vincristine; tositumomab
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Tositumomab I-131
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular 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 the side effects of giving iodine I 131 tositumomab
      together with rituximab and combination chemotherapy and to see how well it works in treating
      patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin
      lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed* grade 1, 2, or 3 follicular B-cell non-Hodgkin lymphoma
             meeting the following criteria:

               -  Bulky stage II or stage III or IV disease

               -  Diffuse large cell component must be < 25% of the biopsy

               -  Confirmed cluster of differentiation antigen 20 (CD20) antigen-positive disease
                  NOTE: *Needle aspiration or cytology are not considered adequate for pathology
                  review

          -  Patient must have unilateral or bilateral bone marrow aspirate and biopsy performed
             within 42 days

               -  Positive biopsy performed > 42 days but < 6 months allowed

          -  Previously untreated disease

          -  Bidimensionally measurable disease

          -  No clinical evidence of central nervous system (CNS) involvement by lymphoma

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-2

          -  Cardiac ejection fraction ≥ 45% by multigated acquisition scan (MUGA) or ECHO

          -  No significant cardiac abnormalities

          -  No known HIV positivity

          -  No requirement for continuous supplemental oxygen therapy

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer from which the patient is currently in complete remission

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 12 months after
             completion of maintenance therapy

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

          -  No prior solid organ transplantation