A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma
The purpose of this study is to: 1. Determine changes in levels of tumor bioactivity upon treatment with atorvastatin. Secondary objective: 2. Determine validity of tumor bioactivity as a biologic endpoint by correlation with clinical response. 3. Determine whether administration of atorvastatin is tolerable and safe in low grade NHL patients. We do not anticipate any significant toxicity since this dose of atorvastatin has been FDA approved for patients with hypercholesterolemia.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Atorvastatin
Phase: Phase 2
Ages Eligible For Study:
- >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