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

Not Recruiting

Trial ID: NCT00185731


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.

Official Title

A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma

Stanford Investigator(s)

Alice C. Fan
Alice C. Fan

Associate Professor of Medicine (Oncology) and, by courtesy, of Urology

Christina Kong
Christina Kong

Professor of Pathology

Yasodha Natkunam, M.D., Ph.D
Yasodha Natkunam, M.D., Ph.D

Ronald F. Dorfman, MBBch, FRCPath Professor of Hematopathology


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

   - 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

   - 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

   - HIV-positive patients receiving combination anti-retroviral therapy


drug: Atorvastatin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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