Trial · NCT00462280
Lovastatin in Treating Patients At High Risk of Melanoma
NCT00462280, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lovastatin in Treating Patients At High Risk of Melanoma. Trials, record NCT00462280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00462280
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lovastatin in Treating Patients At High Risk of Melanoma
- NCT number
- NCT00462280
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Precancerous Condition, Stage 0 Melanoma, Stage I Melanoma, Stage II Melanoma
- Interventions
- lovastatin, placebo, biopsy, laboratory biomarker analysis
- First posted
- 2007-04-19
- Last updated
- 2014-10-31
- Results first posted
- 2014-10-31
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation | 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. |
| Primary | Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation | 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. |
| Secondary | Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations | From baseline up to 24 weeks | 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. |
| Secondary | Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | From baseline up to 24 weeks | 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. |
| Secondary | Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation | From baseline up to 24 weeks | HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. |
| Secondary | Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation | From baseline up to 24 weeks | (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. |
| Secondary | Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation | From baseline up to 24 weeks | (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. |
| Secondary | Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation | From baseline up to 24 weeks | VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. |
| Secondary | Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation | From baseline up to 24 weeks | RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. |
| Secondary | Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation | From baseline up to 24 weeks | p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation | From baseline up to 24 weeks | 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. | score | MEAN |
| SECONDARY | Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations | From baseline up to 24 weeks | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure. | score | MEAN |
| SECONDARY | Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | From baseline up to 24 weeks | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure. | pairs of photos | NUMBER |
| SECONDARY | Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation | From baseline up to 24 weeks | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure. | percentage of cells that are positive | MEAN |
| SECONDARY | Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation | From baseline up to 24 weeks | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure. | percentage of cells that are positive | MEAN |
| PRIMARY | Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation | From baseline up to 24 weeks | 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. | score | MEAN |
| SECONDARY | Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation | From baseline up to 24 weeks | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure. | percentage of cells that are positive | MEAN |
| SECONDARY | Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation | From baseline up to 24 weeks | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure. | percentage of cells that are positive | MEAN |
| SECONDARY | Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation | From baseline up to 24 weeks | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure. | percentage of cells that are positive | MEAN |
| SECONDARY | Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation | From baseline up to 24 weeks | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure. | percentage of cells that are positive | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation | Two Matched Nevi Group - Lovastatin | 0.50 | Standard Deviation 1.10 | score | |
| Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation | Two Matched Nevi Group - Placebo | -0.12 | Standard Deviation 1.33 | score | |
| Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations | Lovastatin | 4.03 | Standard Deviation 0.26 | score | |
| Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations | Placebo | 3.98 | Standard Deviation 0.31 | score | |
| Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | Lovastatin | Fewer nevi after the treatment | 4 | pairs of photos | |
| Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | Placebo | Fewer nevi after the treatment | 3 | pairs of photos | |
| Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | Lovastatin | Same number of nevi after treatment | 64 | pairs of photos | |
| Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | Placebo | Same number of nevi after treatment | 67 | pairs of photos | |
| Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | Lovastatin | More nevi after the treatment | 1 | pairs of photos | |
| Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | Placebo | More nevi after the treatment | 7 | pairs of photos |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Two Matched Nevi Group - Lovastatin | 34 | |
| Overall Study | STARTED | Two Matched Nevi Group - Placebo | 32 | |
| Overall Study | STARTED | One Large Nevi Group - Lovastatin | 7 | |
| Overall Study | STARTED | One Large Nevi Group - Placebo | 7 | |
| Overall Study | COMPLETED | Two Matched Nevi Group - Lovastatin | 24 | |
| Overall Study | COMPLETED | Two Matched Nevi Group - Placebo | 25 | |
| Overall Study | COMPLETED | One Large Nevi Group - Lovastatin | 7 | |
| Overall Study | COMPLETED | One Large Nevi Group - Placebo | 4 | |
| Overall Study | NOT COMPLETED | Two Matched Nevi Group - Lovastatin | 10 | |
| Overall Study | NOT COMPLETED | Two Matched Nevi Group - Placebo | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events584
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | 3 NEW MOLES | Skin and subcutaneous tissue disorders | Two Matched Nevi Group-Lovastatin | 0 | 34 | 0 |
| other | 3 NEW MOLES | Skin and subcutaneous tissue disorders | Two Matched Nevi Group-Placebo | 0 | 32 | 0 |
| other | 3 NEW MOLES | Skin and subcutaneous tissue disorders | One Large Nevi Group-Lovastatin | 1 | 7 | 1 |
| other | 3 NEW MOLES | Skin and subcutaneous tissue disorders | One Large Nevi Group-Placebo | 0 | 7 | 0 |
| other | ACID REFLUX | Gastrointestinal disorders | Two Matched Nevi Group-Lovastatin | 1 | 34 | 1 |
| other | ACID REFLUX | Gastrointestinal disorders | Two Matched Nevi Group-Placebo | 1 | 32 | 1 |
| other | ACID REFLUX | Gastrointestinal disorders | One Large Nevi Group-Lovastatin | 0 | 7 | 0 |
| other | ACID REFLUX | Gastrointestinal disorders | One Large Nevi Group-Placebo | 0 | 7 | 0 |
| other | ALOPECIA | Skin and subcutaneous tissue disorders | Two Matched Nevi Group-Lovastatin | 1 | 34 | 1 |
| other | ALOPECIA | Skin and subcutaneous tissue disorders | Two Matched Nevi Group-Placebo | 0 | 32 | 0 |
1 to 10 of 584Source ClinicalTrials.gov
See all 584 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Two Matched Nevi Group-Lovastatin | ||
| Total, all-cause mortality | Two Matched Nevi Group-Placebo | ||
| Total, all-cause mortality | One Large Nevi Group-Lovastatin | ||
| Total, all-cause mortality | One Large Nevi Group-Placebo | ||
| Total, other adverse events | Two Matched Nevi Group-Lovastatin | 27 | 34 |
| Total, other adverse events | Two Matched Nevi Group-Placebo | 25 | 32 |
| Total, other adverse events | One Large Nevi Group-Lovastatin | 4 | 7 |
| Total, other adverse events | One Large Nevi Group-Placebo | 5 | 7 |
| Total, serious adverse events | Two Matched Nevi Group-Lovastatin | 1 | 34 |
| Total, serious adverse events | Two Matched Nevi Group-Placebo | 2 | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01CN035160 | PHASE I and II CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS-261035-261035160 | MEYSKENS, FRANK L. | REGENTS OF THE UNIVERSITY OF | DIVISION OF CANCER PREVENTION AND CONTROL | 2004 to 2006 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00462280
GET https://conductscience.org/api/trials/v1/NCT00462280/registered?page=2