Status:
COMPLETED
Lovastatin in Treating Patients At High Risk of Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Precancerous Condition
Stage 0 Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 me...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00462280
Start Date
May 1 2007
End Date
February 1 2012
Last Update
October 31 2014
Active Locations (3)
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1
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
2
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
3
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112