NCT00185731

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Apr 2005

Typical duration for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

December 2, 2017

Completed
Last Updated

December 2, 2017

Status Verified

October 1, 2017

Enrollment Period

7.6 years

First QC Date

September 12, 2005

Results QC Date

January 24, 2017

Last Update Submit

October 25, 2017

Conditions

LeukemiaLymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

  • Tumor Apoptosis

    Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment

    1 year

Secondary Outcomes (2)

  • Correlation of Tumor Apoptosis to Clinical Response

    1 year

  • Atorvastatin Toxicity

    1 year

Study Arms (1)

80 mg Atorvastatin

EXPERIMENTAL

Atorvastatin, 80 mg tablet, will be taken orally by the patient daily, beginning on study day 1.

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

80 mg orally once daily

Also known as: Lipitor
80 mg Atorvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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)
  • +17 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

LeukemiaLymphoma, Non-Hodgkin

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Alice Fan, MD
Organization
Stanford University School of Medicine
afan@stanford.edu
650-725-6454

Study Officials

  • Dean Felsher

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

April 1, 2005

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 2, 2017

Results First Posted

December 2, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)