Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma

Inclusion Criteria:

   - > 18 years old

   - Disease criteria: Confirmed by Stanford Pathology to be one of the following
   Non-Hodgkin's Lymphoma (NHL) subtypes:

      - Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)

      - Extranodal marginal zone B-cell lymphoma

      - Nodal marginal zone B-cell lymphoma

      - Splenic marginal zone B-cell lymphoma

   - Treatment criteria

      - Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR

      - Prior treatment: watchful waiting currently appropriate o OR

      - Refractory disease

   - Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma)

      - CT chest (date)

      - CT abdomen (date)

      - CT pelvis (date) OR

   - Staging within 4 weeks prior to enrollment (CLL: CT not required)

      - Total white blood cell count (WBC) (Value) (date)

      - Absolute lymphoma cell count (ALC) (Value) (date)

      - Measurable disease (Site) (Size) OR

      - CLL (only): elevated absolute lymphoma cell count

   - Disease amenable to biopsy (must check at least one):

      - Circulating tumor cells

      - Positive bone marrow

      - Palpable involved site (such as lymph node) measuring > 1.5 cm

   - Eastern Cooperative Oncology Group performance status <2 (Karnofsky >60)

   - Life expectancy of greater than 3 months

   - Patients must have adequate organ and marrow function

      - Absolute neutrophil count > 1,000/uL

      - Platelets > 30,000/uL

      - Total bilirubin within normal institutional limits

      - Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ratio < 2.5 x
      institutional upper limit of normal

      - Creatinine within normal institutional limits OR creatinine clearance > 60
      mL/min/1.73 m² for patients with creatinine levels above institutional normal.

   - Women of child-bearing potential and men must agree to use adequate contraception
   (hormonal or barrier method of birth control; abstinence) prior to study entry and for
   the duration of study participation. Women of child-bearing potential must have
   negative BetaHCG at enrollment

Exclusion Criteria:

   - Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
   prior to entering the study

   - Not recovered from adverse events due to agents administered more than four weeks
   earlier

   - Has stable low grade lymphoma has had rituximab within 3 months Patient with relapsed
   or refractory disease has had rituximab within 1 month

   - Not recovered from adverse events due to surgery performed 4 weeks earlier

   - Receiving any other investigational agent. Known brain metastases

   - Taken any statin within the past 6 months prior to enrollment in the trial

   - Currently abuses alcohol

   - Currently takes cyclosporin or gemfibrozil Patient has a prior history of
   rhabdomyolysis

   - Has uncontrolled intercurrent illness including, but not limited to ongoing or active
   infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
   arrhythmia, or psychiatric illness/social situations that would limit compliance with
   study requirements.

   - Pregnant: Patients are not excluded if they are breastfeeding at the time of
   enrollment, but breastfeeding should be discontinued if the mother is treated with
   atorvastatin.

   - HIV-positive patients receiving combination anti-retroviral therapy