Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab; yttrium Y 90 ibritumomab tiuxetan
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: contiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; stage I grade 1 follicular lymphoma; stage III grade 1 follicular lymphoma; stage IV grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; stage I grade 2 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 2 follicular lymphoma; contiguous stage II marginal zone lymphoma; noncontiguous stage II marginal zone lymphoma; splenic marginal zone lymphoma; stage I marginal zone lymphoma; stage III marginal zone lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; contiguous stage II small lymphocytic lymphoma; noncontiguous stage II small lymphocytic lymphoma; stage I small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90
      ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances
      to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab
      tiuxetan may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90
      ibritumomab tiuxetan works in treating patients with indolent non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the
             following histologic subtypes:

               -  Grade1 or 2 follicular lymphoma

               -  Small lymphocytic lymphoma (SLL)

               -  Marginal zone B-cell lymphoma

          -  CD20-positive disease confirmed by immunohistochemistry or flow cytometry

          -  Bidimensionally measurable disease

               -  At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan

          -  Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone
             marrow aspiration and biopsy within the past 6 weeks

          -  No clinically significant impaired bone marrow reserve as evidenced by any of the
             following:

               -  Hypocellular marrow, as evidenced by 1 of the following:

                    -  ≤ 15% cellularity

                    -  Marked reduction in bone marrow precursors

               -  Platelet count < 100,000/mm^3

               -  Absolute neutrophil count < 1,500/mm^3

               -  History of failed stem cell collection

               -  Prior myeloablative therapy

          -  No greater than 5,000/mm^3 circulating tumor cells in peripheral blood

          -  Requires antilymphoma therapy, as indicated by any of the following:

               -  Systemic symptoms

               -  B symptoms

               -  Cytopenias

               -  Malaise

               -  Organ compromise

               -  Discomfort

               -  Pain

               -  Disfigurement

               -  Rapidly progressive disease

               -  Undue anxiety related to not receiving treatment

          -  No transformation to intermediate or high-grade NHL

          -  No known brain metastases or CNS involvement by lymphoma NOTE: A new classification
             scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of
             "indolent" or "aggressive" lymphoma will replace the former terminology of "low",
             "intermediate", or "high" grade lymphoma. However, this protocol uses the former
             terminology.

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  ECOG 0-2 OR

          -  WHO 0-2 OR

          -  Karnofsky 70-100%

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  See Disease Characteristics

          -  WBC ≥ 3,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Lymphocyte count < 5,000/mm^3 (for patients with SLL )

        Hepatic

          -  Bilirubin ≤ 2.0 mg/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal

        Renal

          -  Creatinine ≤ 2.0 mg/dL OR

          -  Creatinine clearance > 60 mL/min

        Cardiovascular

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

        Immunologic

          -  No anti-murine antibody reactivity (in patients with prior exposure to murine
             antibodies or proteins)

          -  No ongoing or active infection

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biologic composition to yttrium Y 90 ibritumomab tiuxetan

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 1 year after
             study treatment

          -  No other active malignancy except non-melanoma skin cancer

          -  No other serious nonmalignant disease that would preclude study participation

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other uncontrolled illness

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 4 weeks since prior pegfilgrastim

          -  More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

        Chemotherapy

          -  No prior chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior external beam radiotherapy to > 25% of active bone marrow (involved field or
             regional)

        Surgery

          -  More than 4 weeks since prior major surgery except diagnostic surgery

        Other

          -  No prior systemic antilymphoma therapy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational agents

          -  No other concurrent antilymphoma therapy