Lovastatin in Treating Patients At High Risk of Melanoma (NCT00462280) | Clinical Trial Compass
CompletedPhase 2
Lovastatin in Treating Patients At High Risk of Melanoma
United States80 participantsStarted 2007-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation
Timeframe: From baseline up to 24 weeks
2
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation