Bortezomib in Treating Patients With Lymphoproliferative Disorders
Condition: Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoproliferative Disorders; Recurrence
Intervention: bortezomib
Intervention description: Given IV
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase II trial to study the effectiveness of bortezomib in treating patients who have
      low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by
      blocking the enzymes necessary for cancer cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed lymphoproliferative disorder of 1 of the
             following subtypes:

          -  * Relapsed or refractory grade I, II, or III follicular center cell lymphoma

               -  Relapsed or refractory mantle cell lymphoma

          -  Measurable disease for non-Hodgkin's lymphoma (NHL) only

               -  At least 1 unidimensionally measurable lesion

               -  At least 2 cm by conventional techniques OR at least 1 cm by spiral CT scan

               -  Lymph nodes no greater than 1 cm in short axis considered normal

          -  Absolute lymphocytosis greater than 5,000/mm^3 with B-cell phenotype (CD19, 20,or 23
             positive) with more than 30% bone marrow lymphocytes for CLL or other leukemic forms
             of NHL

          -  No known brain metastases

          -  Performance status - Karnofsky 70-100%

          -  At least 3 months

          -  See Disease Characteristics

          -  Absolute neutrophil count greater than 1,500/mm^3 (500/mm^3 if lymphomatous
             involvement of bone marrow)

          -  Platelet count greater than 50,000/mm^3

          -  Bilirubin less than 1.5 times upper limit of normal (ULN)

          -  AST and ALT no greater than 2.5 times ULN (4 times ULN in case of liver metastases)

          -  Creatinine less than 1.5 times ULN

          -  No symptomatic congestive heart failure

          -  No New York Heart Association class III or IV heart disease

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No myocardial infarction within the past 6 months

          -  No cerebrovascular accident or transient ischemic attack within the past 6 months

          -  No history of orthostatic hypotension

          -  No evidence of acute ischemia or significant conduction abnormality (left anterior
             hemiblock in the presence of right bundle branch block or second or third degree
             atrioventricular blocks) on electrocardiogram

          -  No uncontrolled hypertension requiring antihypertensive medication

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Febrile episodes up to 38.5°C allowed if no evidence of active infection

          -  No other uncontrolled concurrent illness

          -  No known or active HIV infection

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study entry

          -  At least 3 months since prior monoclonal antibody therapy (e.g., rituximab)

          -  No more than 3 prior regimens of conventional cytotoxic chemotherapy

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
             recovered

          -  At least 1 week since prior steroid therapy

          -  At least 4 weeks since prior radiotherapy and recovered

          -  At least 4 weeks since prior major surgery

          -  No other concurrent investigational agents