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