Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma
Condition: Contiguous Stage II Adult Diffuse Large Cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Splenic Marginal Zone Lymphoma; Stage I Adult Diffuse Large Cell Lymphoma; Testicular Lymphoma; Waldenström Macroglobulinemia
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Large B-Cell, Diffuse; Waldenstrom Macroglobulinemia
Intervention: rituximab; prednisone; cyclophosphamide; doxorubicin; vincristine; indium In 111 ibritumomab tiuxetan; radiation therapy; positron emission tomography
Intervention description: Given IV; Given orally; Given IV; Given IV; Given IV; Given IV; Undergo radiotherapy; Undergo PET scans
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving rituximab together with combination
      chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or
      stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide,
      doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so
      they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium
      ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive
      cancer-killing substances to them without harming normal cells. Combining a monoclonal
      antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more
      cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed diagnosis of diffuse large cell lymphoma

          -  Patients must be stage I or II (Modified Ann Arbor staging)

          -  Baseline measurements and evaluations must be obtained within 4 weeks of registration
             to the study; abnormal PET scans will not constitute evaluable disease unless verified
             by CT scan or other appropriate imaging; patients must have at least one objective
             measurable disease parameter (a lesion with at least 1 dimension > 1.5 cm); or if they
             are stage 1

          -  Stage I patients must have at least one of the following risk factors:

               -  Age >= 60 years

               -  Bulky disease (>= 5 cm in at least one dimension)

               -  Elevated Lactate Dehydrogenase (LDH) above institutional upper limit of normal

               -  Eastern Cooperative Oncology Group (ECOG) performance status = 2

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count >= 1500/mm^3 (includes neutrophils and bands)

          -  Platelet count >= 100,000/mm^3

          -  Creatinine < 2.0 mg/dl

          -  Total bilirubin < 2 mg/dl (may be up to 3.0 mg/dl if due to liver involvement by
             lymphoma); patients with elevated total bilirubin should have a direct bilirubin
             checked; if the direct bilirubin is normal there is no need for a dose reduction

          -  Patients must have left ventricular ejection fraction (LVEF) of > 45%

          -  Patients must be tested for hepatitis B (HBV) surface antigen within 2 weeks of
             registration

               -  NOTE: Patients who test positive will be allowed to participate but must be
                  followed closely for clinical and laboratory signs of active HBV infection and
                  for signs of hepatitis

        Exclusion Criteria:

          -  Prior chemotherapy, radiation therapy, radioimmunotherapy, or immunotherapy; a short
             course (=< 14 days prior to registration) of corticosteroids is allowed

          -  Evidence of other malignancy:

               -  Prior chemotherapy or prior radiation therapy for other malignancies

               -  Currently receiving hormone therapy or chemotherapy for another malignancy even
                  if the treatment is being provided in the adjuvant treatment setting, i.e. with
                  no evidence of the original other malignancy

               -  Adjuvant hormonal therapy must have been discontinued > 3 months before entering
                  this study

               -  Patients are eligible if they meet the following conditions: (a) treated
                  carcinoma-in-situ of the cervix; (b) treated squamous cell or basal cell skin
                  cancer; or (c) any other surgically cured malignancy from which the patient has
                  been disease free for at least 3 years

          -  Pregnant or breast feeding, as there would be radiation exposure to the fetus or
             child; a negative pregnancy test is required =< 1 week prior to registration for women
             of childbearing potential (WOCBP). Women of childbearing potential and sexually active
             males must be strongly advised to use an accepted and effective method of
             contraception

          -  Known central nervous system (CNS) lymphoma, testicular lymphoma, or vitreous lymphoma

          -  Known HIV infection. The safety of Zevalin™ in this population has not been tested at
             this time

          -  Serious coexisting medical condition or active infection which would compromise the
             ability to deliver standard R-CHOP chemotherapy

          -  Evidence of myelodysplasia on bone marrow aspiration and biopsy