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

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ClinicalTrials.gov Identifier: NCT00489372
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy, no Evidence of Disease Drug: Se-methyl-seleno-L-cysteine Other: placebo Other: pharmacological study Other: laboratory biomarker analysis Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the toxicity of MSC, given to healthy adult males as a single oral dose.

SECONDARY OBJECTIVES:

I. To characterize the pharmacokinetics of single oral doses of MSC in healthy adult male volunteers.

II. To evaluate the baseline selenium content of toenail clippings in healthy adult males.

OUTLINE: This is a multicenter, randomized, placebo controlled, double blind, dose escalation study. Participants are randomized to 1 of 2 arms.

Arm I: Participants receive oral placebo on day 1.

Arm II: Participants receive oral Se-methyl-seleno-l-cysteine (MSC) on day 1. Cohorts of 5 participants receive escalating doses of MSC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 10 patients experience dose-limiting toxicity.

Participants undergo blood, urine, and toenail clipping collection for pharmacokinetic and correlative studies. Samples are analyzed for plasma protein levels of selenium for proteomic and gene expression, molecular fingerprinting by mass spectrometry, and RNA by gene array analysis.

After completion of study treatment, participants are followed at 7-14 days and at 30 days.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase I Study of Single Oral Dose of Se-Methyl-Seleno-L-Cysteine (MSC) in Adult Men
Study Start Date : July 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Arm I (placebo)
Participants receive oral placebo on day 1.
Other: placebo
Given orally
Other Name: PLCB

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies

Experimental: Arm II (Se-methyl-seleno-L-cysteine)
Participants receive oral Se-methyl-seleno-l-cysteine (MSC) on day 1. Cohorts of 5 participants receive escalating doses of MSC until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 10 patients experience dose-limiting toxicity.
Drug: Se-methyl-seleno-L-cysteine
Given orally
Other Names:
  • methylselenocysteine
  • MSC

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Clinical toxicity in healthy adult male volunteers, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0 [ Time Frame: Up to 30 days ]
    Summarized using descriptive statistics.


Secondary Outcome Measures :
  1. Characterization of the pharmacokinetics of MSC [ Time Frame: Up to 24 hours post-dose ]
    Descriptive statistics calculated for each cohort, using established pharmacokinetic analysis methods.

  2. Selenium levels in toenail samples [ Time Frame: Up to 24 hours post-dose ]
    Summarized graphically.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489372


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Raymond Bergan Northwestern University

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00489372     History of Changes
Other Study ID Numbers: NCI-2013-00505
NCI-2013-00505 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 87406
NCI04-4-02
NWU04-4-02 ( Other Identifier: Northwestern University )
NWU04-4-02 ( Other Identifier: DCP )
P30CA060553 ( U.S. NIH Grant/Contract )
N01CN35157 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Selenomethylselenocysteine
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents