Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma
Condition: Mantle-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan
Intervention description: Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4mCi/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
Intervention MeSH terms: Rituximab; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects (good and bad) of the combination of
      ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory
      mantle cell lymphoma.

      Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with
      another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer cells
      and releasing radiation to damage those cells. Both Zevalin and Rituxan are given in this
      study, along with Velcade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with relapsed or refractory Mantle Cell lymphoma with measurable disease.

          -  Age > 18 years old

          -  Expected survival >/= 3 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at
             initiation of study (Appendix I).

          -  Laboratory tests meet the levels specified in the protocol

        Exclusion Criteria:

          -  Patients must not have received chemotherapy, radiation or surgical resection of
             malignancy within 3 weeks of study initiation. However, if they have received
             nitrosurea or mitomycin C then they should not be enrolled in the study until 6 weeks
             after therapy was last received.

          -  No limitations to number of prior therapies

          -  No prior radioimmunotherapy (RIT)

          -  Prior bortezomib is allowed

          -  Patient must be fully recovered from all toxicities associated with prior surgery,
             radiation treatment, chemotherapy or immunotherapy.

          -  No active, serious infection or medical or psychiatric illness likely to interfere
             with participation in this clinic trial

          -  No known HIV infection

          -  No active central nervous system (CNS) involvement

          -  Bone Marrow Involvement >/= 25% within 30 days of initiation of study treatment

          -  Pregnant or breast feeding

          -  No patients who have received Granulocyte colony-stimulating factor (G-CSF) or
             Granulocyte macrophage colony-stimulating factor (GM-CSF) within the 14 days prior to
             initiating protocol

          -  No patient who has had major surgery within the four weeks prior to initiating
             protocol therapy

          -  No patients with pleural effusion or significant ascites