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Phase II Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by Stanford University, September 2008
Sponsors and Collaborators: Stanford University
The Leukemia and Lymphoma Society
Damon Runyon Cancer Research Foundation
Burroughs Wellcome
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00185731
  Purpose

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.

Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: Atorvastatin
Phase II

MedlinePlus related topics: Cancer Cholesterol Lymphoma
Drug Information available for: Atorvastatin Atorvastatin calcium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title: A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Determine changes in levels of tumor bioactivity upon treatment with atorvastatin.

Secondary Outcome Measures:
  • Determine validity of tumor bioactivity as a biologic endpoint by correlation with clinical response.
  • 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.

Estimated Enrollment: 17
Study Start Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  • 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&#xA; 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185731

Contacts
Contact: Alice Fan, MD (650) 224-9047 afan@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Alice Fan, MD     650-224-9047     afan@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061     cctoffice@stanford.edu    
Principal Investigator: Dean Felsher            
Sub-Investigator: Alice Fan            
Sub-Investigator: Dr. Christina S. Kong            
Sub-Investigator: Yasodha Natkunam            
Sub-Investigator: Steven Edward Coutre            
Sponsors and Collaborators
Stanford University
The Leukemia and Lymphoma Society
Damon Runyon Cancer Research Foundation
Burroughs Wellcome
Investigators
Principal Investigator: Dean Felsher Stanford University
  More Information

Study ID Numbers: LYMNHL0020, 4328-07, 95140, LYMNHL0020, NCT00185731
Study First Received: September 12, 2005
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00185731  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Atorvastatin

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009