Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
Condition: Leukemia; Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Atorvastatin
Intervention description: 80 mg orally once daily
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an approach which can inflict significant toxicity. An alternative is to block
      expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach
      which could reduce toxicity to the host while maximizing destruction of the
      oncogene-dependent malignant cells.
    

Eligibility criteria:

        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