A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory 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 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 Cell Count (WBC) (Value) (date)
- Absolute Lymphoma Cell Count (ALC) (Value) (date)
- Measurable disease
1. (Site)
2. (Size) OR
- CLL (only): Elevated Absolute Lymphoma Cell Count
- Disease amenable to biopsy (must check at least one): Li circulating tumor cells
- Li positive bone marrow
- Li palpable involved site (such as lymph node) measuring >1.5 cm
ECOG performance status <2 (Karnofsky >60)
o Status score:
- Life expectancy of greater than 3 months
- Patients must have adequate organ and marrow function (EACH must checked "yes")
(Date)
1. Li absolute neutrophil count >1 ,000/uL
2. Li platelets >30,000/uL
3. Li total bilirubin within normal institutional limits
4. Li AST(SGOT) <2.5 X institutional upper limit of normal
5. Li ALT(SGPT) <2.5 X institutional upper limit of normal
6. Li creatinine within normal institutional limits OR creatinine clearance >60
mL/min/1.73 m^2 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:
- Patient has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas
or mitomycin C) prior to entering the study
- Patient has not recovered from adverse events due to agents administered more than
four weeks earlier
- Patient with stable low grade lymphoma has had rituximab within 3 months Patient with
relapsed or refractory disease has had rituximab within 1 month
- Patient has not recovered from adverse events due to surgery performed 4 weeks
earlier
- Patient is receiving any other investigational agent. Known brain metastases
- Patient has taken any statin within the past 6 months prior to enrollment in the
trial
- Patient currently abuses alcohol
- Patient currently takes cyclosporin or gemfibrozil Patient has a prior history of
rhabdomyolysis
- Patient as 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.
- Patient is pregnant. Note: 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