Precancerous ConditionPhase 2NCT00462280
Lovastatin in Treating Patients At High Risk of Melanoma
A Phase 2 study testing lovastatin, biopsy and laboratory biomarker analysis in people with Precancerous Condition and Stage 0 Melanoma, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial summary
The use of lovastatin may slow disease progression in patients at high risk of melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Precancerous Condition, Stage 0 Melanoma, Stage I Melanoma
- What is being tested?
- lovastatin, biopsy and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2007to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of at least 2 clinically atypical nevi on the body that are reasonably matched in regards to level of clinical atypia, or one atypical mole and another atypical mole >= 8 mm in diameter (for this pair the two moles do not have to be closely matched and only one of them must be >= 8 mm in diameter)
- A history of melanoma is not required for study entry
- Patients with completely resected stage I or II who have not received adjuvant therapy in the past 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better (Karnofsky > 70%)
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
Show all 17Show fewer
- Platelets >= 100,000/uL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X within normal limits
- Creatinine within normal institutional limits
- Ability to understand and the willingness to sign the written informed consent
- Subjects willing and able to participate for the full duration of the study
- For women of child-bearing potential (women are considered not of childbearing potential if they are at least 2 years post-menopausal and/or surgically sterile), she:
- has been using adequate contraception (abstinence, intrauterine device [IUD], birth control pills, or spermicidal gel with diaphragm or condom) since her last menses and will use adequate contraception during the study
- is not lactating, and
- has had a documented negative serum pregnancy test within 30 days prior to the first dose of study medication Should a woman become pregnant or suspect she is pregnant while participating in this study, she will be taken off study and be advised to inform her treating physician immediately; a telephone follow-up with the subject post-delivery will be completed to obtain outcome of pregnancy
- Men partnered with a female of child-bearing age must agree to use adequate contraception while on the study (i.e. abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom)
Who cannot join
- Subjects with untreated melanoma of any stage or locally advanced (>= 4 mm in Breslow's thickness) or metastatic (stage III or IV) melanoma; subjects with melanoma may be considered for trial after complete resection of Stage I or II melanoma and those who have declined or are ineligible to go on any available adjuvant clinical trials known to the investigators or the subjects are eligible
- Subjects who are on adjuvant therapy or experimental therapy for melanoma currently or within the last 3 months prior to enrollment into this study
- Subjects currently or within the last three months before enrollment on lipid lowering agents of any type
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lovastatin
- Clinically significant unrelated systemic illness
- Subjects with any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize his/her participation in and compliance with the study
Show all 15Show fewer
- Subjects may not be receiving any other investigational agents
- Pregnant or breast feeding females, or females of child bearing age not using a reliable method of contraception (use of lovastatin is contraindicated in pregnancy)
- Subjects who have been diagnosed with malignancies other than cutaneous melanoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma within 5 years of study entry, unless they:
- are currently without evidence of disease
- have not received treatment for invasive malignancy in the last 6 months
- have no current or planned therapy, and
- have an expected disease-free survival of at least 5 years from study entry
- Chronic use of: itraconazole; ketoconazole; erythromycin; clarithromycin; telithromycin; human immunodeficiency virus (HIV) protease inhibitors; nefazodone; cyclosporine; gemfibrozil and other fibrates; danazol; amiodarone (amiodarone hydrochloride); verapamil; coumarin anticoagulants; niacin (nicotinic acid) (>= 1 g/day); or large quantities of grapefruit juice (> l quart daily)
- Subjects with a history of coronary artery disease or stroke
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Lovastatin for Various Endpoints of Melanoma Pathobiology
The use of lovastatin may slow disease progression in patients at high risk of melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or placebo works in treating patients at high risk of melanoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the primary endpoint of the trial, by analysis of histopathologic regression of atypical nevi in response to a 6-month trial of oral (PO) lovastatin vs. placebo in subjects with atypical nevi.
SECONDARY OBJECTIVES:
- To evaluate clinical regression of atypical nevi in the lovastatin vs. placebo group.
II. To evaluate the secondary endpoint of changes in nevi numbers on subjects' backs in the lovastatin vs. placebo groups.
III. To evaluate a number of molecular biomarkers as secondary endpoints in the lovastatin vs. placebo groups.
IV. To evaluate the correlation of serum markers known to be affected by lovastatin with the endpoints chosen above.
- To evaluate the safety and tolerability of the dosing regimen, and the dose escalation.
OUTLINE: Patients are randomized into 1 of 2 treatment arms per group.
ARM I: Patients (with two matched nevi OR one large nevi) receive lovastatin PO once daily (QD) for up to 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients (with two matched nevi OR one large nevi) receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks.
- Being tested
- lovastatin, placebo, biopsy, laboratory biomarker analysis
- Medical subject headings
- Precancerous Conditions, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lovastatinDrug
Also called Lovastatin Sodium, Mevacor, Mevinolin, Monacolin K
Given PO
placeboOther
Also called PLCB
Given PO
biopsyProcedure or surgery
Also called biopsies
Correlative studies
laboratory biomarker analysisProcedure or surgery
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Two matched nevi group - Lovastatin | Experimental | Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: lovastatin; Procedure: biopsy; Procedure: laboratory biomarker analysis |
| Two Matched Nevi Group - Placebo | Placebo comparator | Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity Receives: Other: placebo; Procedure: biopsy; Procedure: laboratory biomarker analysis |
| One large nevi group - Lovastatin | Experimental | Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity Receives: Drug: lovastatin; Procedure: biopsy; Procedure: laboratory biomarker analysis |
| One Large Nevi Group - Placebo | Placebo comparator | Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity Receives: Other: placebo; Procedure: biopsy; Procedure: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation
The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.
Measured: From baseline up to 24 weeks
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation
The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.
Measured: From baseline up to 24 weeks
Secondary outcomes (25)
Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations
From close-up photos of target atypical nevi, lesions will be graded clinically. After unblinding of pre- or post-treatment status for photos, the grading score was as follows: 1= Post-treatment (Post-TX) photo shows a complete resolution of atypia relative to pre-treatment (Pre-TX) photo, 2 = Post-TX photo shows a strong lessening of atypia relative to Pre-TX photo, 3 = Post-TX photo shows a mild lessening of atypia relative to Pre-TX photo, 4 = Post-TX and Pre-TX photos show same degree of atypia, 5 = Pre-TX photo shows a mild lessening of atypia relative to Post-TX photo, 6 = Pre-TX photo shows a strong lessening of atypia relative to Post-TX photo, 7 = Pre-TX photo shows a complete resolution of atypia relative to Post-TX photo. The Wilcoxon rank sum test will be applied to compare the scores for patients treated with placebo vs. those treated with lovastatin.
Measured: From baseline up to 24 weeks
Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations
Assessed by photos of subjects' back pre and post treatment. These photos will be used to count, by blinded evaluators, the number of nevi on the back pre and post therapy.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation
HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation
(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation
(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation
VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation
RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation
p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation
Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation
HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation
(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation
(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation
VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation
RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation
p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation
Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Measured: From baseline up to 24 weeks
Change in Cholesterol (mg/dL) From Baseline After Treatment
Measured: Baseline up to 24 weeks
Change in LDL (mg/dL) From Baseline After Treatment
Measured: Baseline up to 24 weeks
Change in HDL (mg/dL) From Baseline After Treatment
Measured: Baseline up to 24 weeks
Change in Triglycerides (mg/dL) From Baseline After Treatment
Measured: Baseline up to 24 weeks
Change in SGOT/AST (U/L) From Baseline After Treatment
Measured: Baseline up to 24 weeks
Change in SGOT/ALT (U/L) From Baseline After Treatment
Measured: Baseline up to 24 weeks
Change in CPK (U/L) From Baseline After Treatment
Measured: Baseline up to 24 weeks
Change in C-reactive Protein (mg/dL) From Baseline After Treatment
Measured: Baseline up to 24 weeks
At Least 1 Study-related Adverse Event Reported During the Study
All participants will be evaluable for toxicity from the time of their informed consent. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0.
Measured: Baseline up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Precancerous ConditionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kenneth Linden, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462280
- Sponsor's protocol ID
- NCI-2009-00896
- Other IDs
- NCI-2009-00896, 2006-4937, UCI03-1-01, CDR0000540141, UCI 06-06, UCI03-1-01, N01CN35160
- Status last verified
- Feb 2014
- First submitted
- 18 Apr 2007
- Last updated
- 31 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Lovastatin for Various Endpoints of Melanoma Pathobiology
- ClinicalTrials.gov ID
- NCT00462280
- Acronym / sponsor ID
- NCI-2009-00896
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 31 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of lovastatin may slow disease progression in patients at high risk of melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or placebo works in treating patients at high risk of melanoma.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the primary endpoint of the trial, by analysis of histopathologic regression of atypical nevi in response to a 6-month trial of oral (PO) lovastatin vs. placebo in subjects with atypical nevi.
SECONDARY OBJECTIVES:
- To evaluate clinical regression of atypical nevi in the lovastatin vs. placebo group.
II. To evaluate the secondary endpoint of changes in nevi numbers on subjects' backs in the lovastatin vs. placebo groups.
III. To evaluate a number of molecular biomarkers as secondary endpoints in the lovastatin vs. placebo groups.
IV. To evaluate the correlation of serum markers known to be affected by lovastatin with the endpoints chosen above.
- To evaluate the safety and tolerability of the dosing regimen, and the dose escalation.
OUTLINE: Patients are randomized into 1 of 2 treatment arms per group.
ARM I: Patients (with two matched nevi OR one large nevi) receive lovastatin PO once daily (QD) for up to 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients (with two matched nevi OR one large nevi) receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Two matched nevi group - Lovastatin | Experimental | Drug: lovastatin, Procedure: biopsy, Procedure: laboratory biomarker analysisPatients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. |
| Two Matched Nevi Group - Placebo | Placebo comparator | Other: placebo, Procedure: biopsy, Procedure: laboratory biomarker analysisPatients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity |
| One large nevi group - Lovastatin | Experimental | Drug: lovastatin, Procedure: biopsy, Procedure: laboratory biomarker analysisPatients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity |
| One Large Nevi Group - Placebo | Placebo comparator | Other: placebo, Procedure: biopsy, Procedure: laboratory biomarker analysisPatients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Presence of at least 2 clinically atypical nevi on the body that are reasonably matched in regards to level of clinical atypia, or one atypical mole and another atypical mole >= 8 mm in diameter (for this pair the two moles do not have to be closely matched and only one of them must be >= 8 mm in diameter)
- A history of melanoma is not required for study entry
- Patients with completely resected stage I or II who have not received adjuvant therapy in the past 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better (Karnofsky > 70%)
- Leukocytes >= 3,000/uL
Key exclusion criteria (15 listed)
- Subjects with untreated melanoma of any stage or locally advanced (>= 4 mm in Breslow's thickness) or metastatic (stage III or IV) melanoma; subjects with melanoma may be considered for trial after complete resection of Stage I or II melanoma and those who have declined or are ineligible to go on any available adjuvant clinical trials known to the investigators or the subjects are eligible
- Subjects who are on adjuvant therapy or experimental therapy for melanoma currently or within the last 3 months prior to enrollment into this study
- Subjects currently or within the last three months before enrollment on lipid lowering agents of any type
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lovastatin
- Clinically significant unrelated systemic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lovastatinAlso: Lovastatin Sodium, Mevacor, Mevinolin, Monacolin KGiven PO | Drug | One large nevi group - Lovastatin, Two matched nevi group - Lovastatin |
| placeboAlso: PLCBGiven PO | Other | One Large Nevi Group - Placebo, Two Matched Nevi Group - Placebo |
| biopsyAlso: biopsiesCorrelative studies | Procedure or surgery | One Large Nevi Group - Placebo, One large nevi group - Lovastatin, Two Matched Nevi Group - Placebo, Two matched nevi group - Lovastatin |
| laboratory biomarker analysisCorrelative studies | Procedure or surgery | One Large Nevi Group - Placebo, One large nevi group - Lovastatin, Two Matched Nevi Group - Placebo, Two matched nevi group - Lovastatin |
Primary outcome
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation
Time frame: From baseline up to 24 weeks
The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation
Time frame: From baseline up to 24 weeks
The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.
25 secondary outcomes
Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations
Time frame: From baseline up to 24 weeks
Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation
Time frame: From baseline up to 24 weeks
Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation
Time frame: From baseline up to 24 weeks
Change in Cholesterol (mg/dL) From Baseline After Treatment
Time frame: Baseline up to 24 weeks
Change in LDL (mg/dL) From Baseline After Treatment
Time frame: Baseline up to 24 weeks
Change in HDL (mg/dL) From Baseline After Treatment
Time frame: Baseline up to 24 weeks
Change in Triglycerides (mg/dL) From Baseline After Treatment
Time frame: Baseline up to 24 weeks
Change in SGOT/AST (U/L) From Baseline After Treatment
Time frame: Baseline up to 24 weeks
Change in SGOT/ALT (U/L) From Baseline After Treatment
Time frame: Baseline up to 24 weeks
Change in CPK (U/L) From Baseline After Treatment
Time frame: Baseline up to 24 weeks
Change in C-reactive Protein (mg/dL) From Baseline After Treatment
Time frame: Baseline up to 24 weeks
At Least 1 Study-related Adverse Event Reported During the Study
Time frame: Baseline up to 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Precancerous Condition
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Linden principal investigator
Chao Family Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lovastatin, biopsy and laboratory biomarker analysis in people with Precancerous Condition and Stage 0 Melanoma, run by National Cancer Institute (NCI) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation (time frame: From baseline up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.