Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00185731 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
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Sponsor:
Dean Felsher
Collaborators:
The Leukemia and Lymphoma Society
Damon Runyon Cancer Research Foundation
Burroughs Wellcome
Information provided by (Responsible Party):
Dean Felsher, Stanford University
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 12, 2005 | ||||||
First Posted Date ICMJE | September 16, 2005 | ||||||
Results First Submitted Date ICMJE | January 24, 2017 | ||||||
Results First Posted Date ICMJE | December 2, 2017 | ||||||
Last Update Posted Date | December 2, 2017 | ||||||
Study Start Date ICMJE | April 2005 | ||||||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Tumor Apoptosis [ Time Frame: 1 year ] Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment
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Original Primary Outcome Measures ICMJE |
Determine changes in levels of tumor bioactivity upon treatment with atorvastatin. | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma | ||||||
Official Title ICMJE | A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma | ||||||
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. | ||||||
Detailed Description | Atorvastatin has been shown to decrease levels of active oncogenes in preclinical studies with murine and human lymphoma cell lines, and administration of statins leads to shrinkage of lymphoma in murine models. Therefore, it may be possible for atorvastatin to decrease levels of active oncogenes in human lymphomas. Further, upon decrease in levels of active oncogenes, human lymphomas may regress. Atorvastatin is a commonly prescribed drug for hypercholesterolemia: targeting the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase enzyme may also be a way to decrease activation of oncogenes in human lymphoma, with minimal toxicity. For human low grade non-Hodgkin lymphoma, no curative treatment is available; therefore new, non-toxic and targeted therapies are sought for this disease. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Atorvastatin
80 mg orally once daily
Other Name: Lipitor
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Study Arms ICMJE | Experimental: 80 mg Atorvastatin
Atorvastatin, 80 mg tablet, will be taken orally by the patient daily, beginning on study day 1.
Intervention: Drug: Atorvastatin
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
25 | ||||||
Original Enrollment ICMJE |
14 | ||||||
Actual Study Completion Date ICMJE | November 2012 | ||||||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00185731 | ||||||
Other Study ID Numbers ICMJE | IRB-13683 4328-07 ( Other Identifier: Damon Runyon Cancer Research Foundation ) 95140 ( Other Identifier: Stanford University Alternate IRB Approval Number ) LYMNHL0020 ( Other Identifier: OnCore ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Dean Felsher, Stanford University | ||||||
Study Sponsor ICMJE | Dean Felsher | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Stanford University | ||||||
Verification Date | October 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |