S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab; cyclophosphamide; doxorubicin; prednisone; vincristine; tositumomab
Intervention description: Given IV; Given IV; Given IV; Given orally; Given IV; Given IV
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 571.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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; 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

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from
      dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either
      kill them or deliver radioactive tumor-killing substances to them without harming normal
      cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is
      more effective in treating non-Hodgkin's lymphoma.

      PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given
      together with combination chemotherapy to see how well they work in treating patients with
      newly-diagnosed non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed previously untreated bulky stage II or stage III or IV
             follicular non-Hodgkin's lymphoma

               -  Grade I-III disease

          -  Cluster of differentiation antigen 20 (CD20) antigen positive

          -  Fewer than 5,000/mm^3 circulating lymphoid cells on a white blood cell (WBC)
             differential count

          -  Bidimensionally measurable disease

          -  Bone marrow aspiration and biopsy within the past 42 days

          -  No clinical evidence of central nervous system (CNS) involvement by lymphoma

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Zubrod 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  See Disease Characteristics

          -  Granulocyte count greater than 1,500/mm^3

          -  Platelet count greater than 100,000/mm^3

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Cardiovascular:

          -  No impaired cardiac status, including:

               -  Severe coronary artery disease

               -  Cardiomyopathy

               -  Congestive heart failure

               -  Serious arrhythmia

          -  Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan
             (MUGA) or 2-D echocardiogram for questionable cardiac history

        Other:

          -  No hypersensitivity to iodine

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 6 months after study
             participation

          -  HIV negative

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior monoclonal antibodies for cancer

        Chemotherapy:

          -  No prior chemotherapy for lymphoma

               -  Prior prednisone for non-lymphoma related illnesses allowed

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy for lymphoma

        Surgery:

          -  See Disease Characteristics