Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chicago, Illinois 60612


Purpose:

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.


Criteria:

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


NCT ID:

NCT00093561


Primary Contact:

Principal Investigator
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: December 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.