Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: rituximab; cytarabine; liposomal cytarabine; yttrium Y 90 ibritumomab tiuxetan
Intervention description: to be used for CNS prophylaxis; to be used as CNS prophylaxis
Intervention MeSH terms: Cytarabine; Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Standard Phase 2
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; anaplastic large cell lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab,
      can locate cancer cells and either kill them or deliver radioactive cancer-killing substances
      to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with
      rituximab may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab
      tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large
      B-cell non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of
             the following:

               -  B-cell diffuse large cell variant

               -  Immunoblastic

               -  Mediastinal (thymic) large cell

               -  T-cell/histiocyte-rich

               -  Anaplastic large B-cell

               -  Intravascular large B-cell

               -  Lymphomatoid granulomatosis

          -  Relapsed or refractory disease after at least 1 prior chemotherapy regimen and
             requires further treatment

               -  Relapsed disease, defined as the following:

                    -  Appearance of any new lesion OR increase of at least 50% in the size of a
                       previously involved site

                    -  50% increase in greatest diameter of any previously identified node greater
                       than 1 cm in the short axis OR in the sum of the perpendicular diameter
                       (SPD) of more than 1 node

               -  Progressive disease, defined as the following:

                    -  50% increase from nadir in the SPD of any previously identified abnormal
                       node

                    -  Appearance of any new lesion during or at the end of therapy

          -  CD20-positive disease by immunohistochemistry

          -  Bidimensionally measurable disease

               -  At least 1 lesion at least 2.0 cm by CT scan

          -  Less than 25% bone marrow involvement by lymphoma

          -  No transformed lymphoma from indolent to aggressive

          -  No HIV- or AIDS-related lymphoma

          -  No hypocellular bone marrow

          -  No marked reduction in bone marrow precursors of 1 or more cell lines (e.g.,
             granulocytic, megakaryocytic, or erythroid)

          -  No CNS lymphoma

          -  Ineligible for myeloablative therapy OR refused transplantation

          -  Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational
             protocols

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  WHO 0-2

        Life expectancy

          -  At least 3 months

        Hematopoietic

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic
             lymphoma)

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 2.0 mg/dL

        Renal

          -  Creatinine no greater than 2.0 mg/dL

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 1 year after study
             participation

          -  No concurrent serious nonmalignant disease or infection that would preclude study
             participation

          -  No human antimurine antibody reactivity

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

          -  No prior autologous bone marrow transplantation

          -  No prior peripheral blood stem cell rescue

          -  No prior failed stem cell collection

          -  Prior rituximab within the past 90 days allowed provided patient has
             fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid
             disease in at least 1 lesion

          -  More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

        Chemotherapy

          -  See Disease Characteristics

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radioimmunotherapy

          -  No prior external beam radiotherapy (involved field or regional) to more than 25% of
             active bone marrow

        Surgery

          -  More than 4 weeks since prior major surgery (except diagnostic surgery)

        Other

          -  Recovered from all prior therapy

          -  More than 4 weeks since prior therapy for lymphoma

          -  More than 8 weeks since prior phase II investigational drugs

          -  No other concurrent antineoplastic therapy