Se-Methyl-Seleno-L- Cysteine (MSC) in Treating Healthy Patients

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This randomized phase I trial is studying the side effects and best dose of Se-methyl-seleno-L-cysteine in healthy adult men. Studying samples of blood, urine, and toenail clippings in the laboratory from healthy men receiving Se-methyl-seleno-L-cysteine may help doctors learn more about how Se-methyl-seleno-L-cysteine works in the body.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Selenomethylselenocysteine

Criteria

Inclusion Criteria:

• Total body weight between 50 and 115 kg

• Hgb > 12 gm/dl

• Platelets > 100,000/μL

• ANC > 1000/μL

• Creatinine < 1.5 mg/dl

• SGPT and SGOT < 3 X the institutional upper limit of normal (ULN)

• Total bilirubin < 1.5 X the institutional ULN (subjects with a higher level of bilirubin due to a familial metabolism will be considered on an individual basis)

• Life expectancy greater than 2 years

• Male subjects must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and until study completion (i.e., at least two weeks after dose of study drug)

• Ability to understand and the willingness to sign a written informed consent document

• Agree to refrain from use of selenium supplements while on study

Exclusion Criteria:

• Not willing to remain at RPCI, and in follow up, as required

• Presence of medical conditions, which in the opinion of the investigators, would compromise either the subject, or the integrity of the data

• Individuals with a history of active liver or kidney disease within the past 6 months

• Treatment with an investigational drug within 30 days prior to the dose of study drug

• Use of prescription or nonprescription drugs, vitamins, or herbal supplements known to change gastric acidity (e.g., H2-antagonists, proton pump inhibitors, antacids) within 3 days of study drug administration

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MSC (e.g. reaction to other selenium supplements)

• Subjects who have donated 1 unit of blood within 30 days prior to the first dose of MSC

• Subjects with a known history of heavy metal exposure, such as lead, mercury, of arsenic

• ECOG performance status > 1

• AUA total symptom score > 10 (or any individual symptom score of greater than or equal to 4 will exclude the participant)