Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Zevalin; Rituximab; ^111 In Ibritumomab Tiuxetan
Intervention description: .3 mCi IV Over 10 Minutes x 1 Day; 250 mg/m^2 IV Over 6 to 8 Hours; 1.6 mg IV Over 10 Minutes x 1 Day
Intervention MeSH terms: Rituximab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Indolent Lymphoma; Extranodal Marginal; Nodal Marginal Zone; Splenic Marginal; MALT Type; Zevalin; Ibritumomab Tiuxetan; Rituximab

Summary:

      Primary Objective:

        -  Overall Response Rate (ORR).

      Secondary Objectives:

        -  The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients
           and in the responders.

        -  Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses
           (PR).

        -  Time to next anticancer therapy (TTNT).
    

Eligibility criteria:

        Inclusion Criteria:

          1. No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or
             Mitomycin C) prior to study initiation, and fully recovered from acute toxicities
             associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.

          2. Previously treated patients with a histology of refractory/relapsed indolent lymphomas
             including: (a) Extranodal marginal lymphoma of MALT type; (b) Nodal Marginal zone
             B-cell lymphoma (+/- monocytoid cells); (c) Splenic marginal B-cell lymphoma (+/-
             villous lymphocytes).

          3. Signed informed consent

          4. Age >/= 18 years

          5. Expected survival >/= 3 months

          6. Pre-study Zubrod performance status of 0, 1, or 2

          7. Acceptable hematologic status within two weeks prior to patient registration,
             including: (a) Absolute neutrophil count ([segmented neutrophils + bands] * total
             white blood count (WBC)) >/= 1,500/mm^3; (b) Platelet counts >/= 100,000/mm^3.

          8. Female patients who are not pregnant or lactating

          9. Men and women of reproductive potential who are following accepted birth control
             methods (as determined by the treating physician)

         10. Patients previously on Phase II drugs if no long-term toxicity is expected, and the
             patient has been off the drug for eight or more weeks with no significant post
             treatment toxicities observed

         11. Patients determined to have < 25% bone marrow involvement with lymphoma within six
             weeks of registration (define measurement of a bone marrow aspirate or biopsy) (This
             criteria must be strictly met for adequate patient safety.)

         12. Patient should have at least one lesion measuring >/= 2 cm in a single dimension.

        Exclusion Criteria:

          1. Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or
             peripheral blood stem cell (PBSC) rescue.

          2. Platelet count< 100,000 cells/mm^3.

          3. Presence of hypocellular bone marrow.

          4. Patients with history of failed stem cell collection.

          5. Prior radioimmunotherapy

          6. Presence of Central Nervous System (CNS) lymphoma

          7. Patients with HIV.

          8. Patients with pleural effusion

          9. Patients with abnormal liver function: total bilirubin > 2.0 mg/dL

         10. Patients with abnormal renal function: serum creatinine > 2.0 mg/dL

         11. Patients who have received prior external beam radiation therapy to > 25% of active
             bone marrow (involved field or regional)

         12. Patients who have received short-acting growth factor support (Leukine, Neupogen,
             Procrit) within 2 weeks prior to treatment or long-acting growth-factor support
             (Aranesp), Neulasta) within 4 weeks prior to treatment.

         13. Serious nonmalignant disease or infection which, in the opinion of the investigator
             and/or the sponsor, would compromise other protocol objectives

         14. Major surgery, other than diagnostic surgery, within four weeks

         15. Evidence of transformation in the latest biopsy