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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Leukemia and Lymphoma Society
Damon Runyon Cancer Research Foundation
Burroughs Wellcome
Information provided by (Responsible Party):
Dean Felsher, Stanford University
ClinicalTrials.gov Identifier:
NCT00185731
First received: September 12, 2005
Last updated: March 7, 2013
Last verified: March 2013
  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
Leukemia
Lymphoma, Non-Hodgkin
Drug: Atorvastatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Determine changes in levels of tumor bioactivity upon treatment with atorvastatin. [ Time Frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment. Fine needle aspirate and blood samples are batched and analyzed within 1 year of obtaining each sample endpoint. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine validity of tumor bioactivity as a biologic endpoint by correlation with clinical response. [ Time Frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment. ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 23
Study Start Date: April 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
Atorvastatin, 80mg tablet, will be taken orally by the patient daily, beginning on study day 1.
Drug: Atorvastatin
80 mg orally once daily
Other Name: Lipitor

  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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185731

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Dean Felsher
The Leukemia and Lymphoma Society
Damon Runyon Cancer Research Foundation
Burroughs Wellcome
Investigators
Principal Investigator: Dean Felsher Stanford University
  More Information

No publications provided

Responsible Party: Dean Felsher, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00185731     History of Changes
Other Study ID Numbers: LYMNHL0020, 4328-07, 95140, LYMNHL0020, 13683
Study First Received: September 12, 2005
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014