Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Ibritumomab Tiuxetan (Zevalin); Rituximab
Intervention description: 111In Zevalin (5 mCi of ^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1.
90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8.; 250 mg/m^2 Intravenously Over 4-6 Hours On Days 1 and 8.
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's Lymphoma; Lymphoma; Indolent Lymphomas; Ibritumomab Tiuxetan; Zevalin

Summary:

      The goal of this clinical research study is to find out if giving (Rituxan) rituximab with
      90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma.
      The safety of this combination treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin
             lesions will be eligible provided that the skin is the only site of involvement.

          2. Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas
             including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal
             Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell
             lymphoma (+/- villous lymphocytes).

          3. Signed Informed Consent.

          4. Age >/= 18 years.

          5. Pre-study Zubrod performance status of 0, 1, or 2.

          6. Acceptable hematologic status within two weeks prior to patient registration,
             including: absolute neutrophil count ([segmented neutrophils + bands] x total WBC) >/=
             1, 500/mm^3, total lymphocyte count </= 5,000/mm^3 and platelet counts >/=
             100,000/mm^3.

          7. Female patients who are not pregnant or lactating.

          8. Men and women of reproductive potential who are following accepted birth control
             methods (as determined by the treating physician, however abstinence is not an
             acceptable method).

          9. Patients determined to have < 25% bone marrow involvement with lymphoma within six
             weeks of registration (define measurement of a bone marrow aspirate or biopsy).

         10. Patient should have at least one lesion measuring >/= 1.5 cm in a single dimension.
             Measurable cutaneous lesions are allowed.

        Exclusion Criteria:

          1. Presence of central nervous system (CNS) lymphoma.

          2. Patients with HIV or AIDS-related lymphoma.

          3. Patients with pleural effusion.

          4. Patients with abnormal liver function: total bilirubin > 2.0 mg/dL.

          5. Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.

          6. Patients who have received prior external beam radiation therapy to > 25% of active
             bone marrow (involved field or regional).

          7. Impaired bone marrow reserve as indicated by < 15% bone marrow cellularity

          8. Serious nonmalignant disease or infection which, in the opinion of the investigator
             and/or the sponsor, would compromise other protocol objectives.

          9. Major surgery, other than diagnostic surgery, within four weeks.

         10. Evidence of transformation in the latest biopsy.