Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders
Condition: Lymphoproliferative Disorder
MeSH terms: Lymphoproliferative Disorders
Intervention: rituximab; bortezomib
Intervention description: 375 mg/m^2 intravenously on Days 1,8, 15 and 22; 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22
Intervention MeSH terms: Rituximab; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post-transplant lymphoproliferative disorder

Summary:

      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such
      as rituximab, can block cancer cell 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. Giving bortezomib together with rituximab may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab
      works in treating patients with post-transplant lymphoproliferative disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed CD20+ B-cell post-transplant lymphoproliferative disorder

          -  Has undergone prior solid organ transplant

          -  Measurable disease as defined by Non-Hodgkin Lymphoma Response Criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count (ANC) ≥ 1,000/mm³

          -  Platelet count ≥ 75,000/mm³

          -  Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min

          -  Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 3 times upper limit
             of normal

          -  Total bilirubin ≤ 2.0 mg/dL

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Peripheral neuropathy ≥ grade 2

          -  Known lymphomatous meningitis or central nervous system (CNS) involvement

          -  HIV infection

          -  Uncontrolled infection

          -  Myocardial infarction within the past 6 months or uncontrolled angina

          -  New York Heart Association class III-IV heart failure

          -  Severe uncontrolled ventricular arrhythmias

          -  Evidence of acute ischemia or active conduction system abnormalities by
             electrocardiogram (EKG)

          -  Concurrent serious medical or psychiatric disorder (e.g., active infection or
             uncontrolled diabetes) that, in the opinion of the investigator, would compromise the
             safety of the patient or compromise the patient's ability to complete the study

          -  Diagnosis or treatment for another malignancy within the past 3 years, except
             completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in
             situ malignancy, or curatively treated low-risk prostate cancer

          -  Known hypersensitivity to rituximab, bortezomib, boron, or any of the other agents
             used in this study

          -  Less than 14 days since prior investigational drugs

          -  Less than 4 weeks since prior bortezomib therapy (12 weeks for rituximab) and
             recovered from toxic effects prior to enrollment