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Lovastatin in Treating Patients At High Risk of Melanoma

Primary Purpose

Precancerous Condition, Stage 0 Melanoma, Stage I Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lovastatin
placebo
biopsy
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Precancerous Condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University of California Medical Center At Irvine-Orange Campus
  • H. Lee Moffitt Cancer Center and Research Institute
  • Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Two matched nevi group - Lovastatin

Two Matched Nevi Group - Placebo

One large nevi group - Lovastatin

One Large Nevi Group - Placebo

Arm Description

Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.

Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity

Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity

Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in Cholesterol (mg/dL) From Baseline After Treatment
Change in LDL (mg/dL) From Baseline After Treatment
Change in HDL (mg/dL) From Baseline After Treatment
Change in Triglycerides (mg/dL) From Baseline After Treatment
Change in SGOT/AST (U/L) From Baseline After Treatment
Change in SGOT/ALT (U/L) From Baseline After Treatment
Change in CPK (U/L) From Baseline After Treatment
Change in C-reactive Protein (mg/dL) From Baseline After Treatment
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.

Full Information

First Posted
April 18, 2007
Last Updated
October 24, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00462280
Brief Title
Lovastatin in Treating Patients At High Risk of Melanoma
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Lovastatin for Various Endpoints of Melanoma Pathobiology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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: I. 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: I. 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. V. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Condition, Stage 0 Melanoma, Stage I Melanoma, Stage II Melanoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two matched nevi group - Lovastatin
Arm Type
Experimental
Arm Description
Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
Arm Title
Two Matched Nevi Group - Placebo
Arm Type
Placebo Comparator
Arm Description
Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
Arm Title
One large nevi group - Lovastatin
Arm Type
Experimental
Arm Description
Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
Arm Title
One Large Nevi Group - Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
lovastatin
Other Intervention Name(s)
Lovastatin Sodium, Mevacor, Mevinolin, Monacolin K
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
biopsy
Other Intervention Name(s)
biopsies
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation
Description
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.
Time Frame
From baseline up to 24 weeks
Title
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation
Description
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.
Time Frame
From baseline up to 24 weeks
Secondary Outcome Measure Information:
Title
Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations
Description
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.
Time Frame
From baseline up to 24 weeks
Title
Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations
Description
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.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation
Description
HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation
Description
(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.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation
Description
(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.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation
Description
VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation
Description
RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation
Description
p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation
Description
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.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation
Description
HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation
Description
(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.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation
Description
(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.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation
Description
VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation
Description
RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation
Description
p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.
Time Frame
From baseline up to 24 weeks
Title
Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation
Description
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.
Time Frame
From baseline up to 24 weeks
Title
Change in Cholesterol (mg/dL) From Baseline After Treatment
Time Frame
Baseline up to 24 weeks
Title
Change in LDL (mg/dL) From Baseline After Treatment
Time Frame
Baseline up to 24 weeks
Title
Change in HDL (mg/dL) From Baseline After Treatment
Time Frame
Baseline up to 24 weeks
Title
Change in Triglycerides (mg/dL) From Baseline After Treatment
Time Frame
Baseline up to 24 weeks
Title
Change in SGOT/AST (U/L) From Baseline After Treatment
Time Frame
Baseline up to 24 weeks
Title
Change in SGOT/ALT (U/L) From Baseline After Treatment
Time Frame
Baseline up to 24 weeks
Title
Change in CPK (U/L) From Baseline After Treatment
Time Frame
Baseline up to 24 weeks
Title
Change in C-reactive Protein (mg/dL) From Baseline After Treatment
Time Frame
Baseline up to 24 weeks
Title
At Least 1 Study-related Adverse Event Reported During the Study
Description
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.
Time Frame
Baseline up to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Linden
Organizational Affiliation
Chao Family Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Medical Center At Irvine-Orange Campus
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lovastatin in Treating Patients At High Risk of Melanoma

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