Expired Study
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Chicago, Illinois 60612


RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer. PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.

Study summary:

OBJECTIVES: - Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants. - Determine the pharmacokinetics of this agent in these participants. - Determine the dose range of this agent in these participants. OUTLINE: This is a dose-escalation study. Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1. Cohorts of 5 participants 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 participants experience dose-limiting toxicity. Participants are evaluated periodically for 28 days. PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.


DISEASE CHARACTERISTICS: - Healthy participants in good medical condition - No chronic medical conditions - No regular use of prescription medications - No evidence of psychiatric disorder - Non-smoker - Former smokers allowed provided they have not smoked within the past 3 months - No history of alcohol abuse - Serum lycopene concentration < 700 nM PATIENT CHARACTERISTICS: Age - 18 to 45 Performance status - Karnofsky 100% Life expectancy - Not specified Hematopoietic - Hemoglobin ≥ 13.0 g/dL - WBC ≥ 4,000/mm^3 - Platelet count 150,000-400,000/mm^3 Hepatic - AST and ALT ≤ 75 U/L - Bilirubin ≤ 2.0 mg/dL - No liver disease Renal - Creatinine ≤ 1.5 mg/dL - No renal disease Cardiovascular - No cardiovascular disease - No abnormal EKG Other - Within 15% of ideal body weight - No history of gastrointestinal malabsorption or other condition that would preclude drug absorption - No alcohol consumption within the past 72 hours - No allergy to tomato-based products - No history of cancer - No diabetes mellitus - No other illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 4 weeks since prior experimental drugs - More than 14 days since prior prescription drugs - No concurrent participation in another experimental trial - No concurrent prescription drugs



Primary Contact:

Principal Investigator
Keith A. Rodvold
University of Illinois

Backup Contact:


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: October 09, 2019

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