Expired Study
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Chicago, Illinois 60612


Purpose:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer. PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.


Study summary:

OBJECTIVES: - Determine any dose limiting toxicities and the maximum tolerated dose of lycopene administered orally as a food based delivery system in healthy male subjects 18-45 years of age for the chemoprevention of prostate cancer. - Determine the pharmacokinetics of this regimen in this population. - Determine the dose range of this regimen to be used in the 3 month multiple dose study, based on the toxicity, pharmacokinetics and feasibility resulting from the present study in this population. OUTLINE: This is a dose-escalation study. Patients receive a single dose of oral lycopene in a mixture of tomato paste, water, and olive oil over 15 minutes on day 1. Patients are asked to maintain a diet that contains negligible carotinoid for 28 days. Cohorts of 5 patients receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicities. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Normal healthy males judged to be in good medical condition based on history and physical exam confirming the absence of chronic medical conditions - Baseline serum lycopene less than 600 nM PATIENT CHARACTERISTICS: Age: - 18 to 45 Performance status: - Karnofsky 100% Life expectancy: - Not specified Hematopoietic: - Hematologic function normal Hepatic: - Liver function normal - No hepatic disease Renal: - Kidney function normal - No renal disease Cardiovascular: - No hypertension requiring medication - No cardiovascular disease - Normal EKG Other: - No evidence of a psychiatric disorder - Must be within 15% of ideal body weight based on standard weight tables - No history of smoking within the past 3 months - At least 72 hours since prior alcohol consumption and no history of alcohol abuse - No history of gastrointestinal malabsorption or any other condition that could affect drug absorption - No allergy to tomato based products - No active malignancy at any site - No illness that would pose a threat or additional risk (e.g., thyroid disease, diabetes mellitus) PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 14 days since prior prescription drugs - No concurrent regular prescription medications - At least 30 days since other prior experimental drugs - No concurrent participation in any other experimental trial


NCT ID:

NCT00006078


Primary Contact:

Study Chair
Keith A. Rodvold
University of Illinois


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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