S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: rituximab; bortezomib; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate
Intervention description: 375 mg/m^2 on day 1 for cycles 1-6.; 1.3 mg/m^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14.; 750 mg/m^2 on day 1 of cycles 1-6.; 50 mg/m^2 on day 1 of cycles 1-6.; 100 mg on days 1-5 of cycles 1-6.; 1.4 mg/m^2 on day 1 of cycles 1-6.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell 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 find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the
      enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and
      bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the
      cancer from progressing.

      PURPOSE: This phase II trial is studying how well giving rituximab together with combination
      chemotherapy and bortezomib followed by bortezomib alone works in treating patients with
      newly diagnosed mantle cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria:

               -  Stage III-IV or bulky stage II disease

               -  Confirmation of positivity for the following phenotypes by immunohistochemistry
                  or flow cytometry:

                    -  Cluster of differentiation antigen 19 (CD19) (or CD20)

                    -  Cyclin D1 OR evidence of t(11;14) translocation by cytogenetic analysis or
                       fluorescent in situ hybridization

          -  Newly diagnosed, previously untreated disease

          -  Bidimensionally measurable disease by conventional techniques

               -  No nonmeasurable disease only

          -  Adequate tumor tissue from original diagnostic specimen available

               -  Tissue obtained by needle aspiration or cytology not allowed

          -  No clinical evidence of central nervous system (CNS) involvement by lymphoma

          -  Co-registration on protocols SWOG-8947 and SWOG-8819 is strongly encouraged

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-2

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No peripheral neuropathy ≥ grade 2

          -  No hypersensitivity to bortezomib, boron, or mannitol

          -  No other prior malignancy except for adequately treated basal cell or squamous cell
             skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for
             which the patient is currently in complete remission, or any other cancer for which
             the patient has been disease free for the past 5 years

          -  HIV negative

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

          -  More than 14 days since prior investigational drugs