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Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants

Primary Purpose

No Evidence of Disease, Prostate Carcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Selenium
Placebo
Laboratory Biomarker Analysis
Pharmacological Study
Methylselenocysteine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for No Evidence of Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Total body weight between 50 and 115 kg (110 and 250 lbs)
  • Hemoglobin (Hgb) > 12 mg/dL
  • Platelet count > 100,000/μL
  • Absolute neutrophil count (ANC) > 1000/μL
  • Creatinine =< institutional upper limit of normal (ULN)
  • Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) < 2.0 x ULN
  • Total bilirubin =< ULN (participants with a higher level of bilirubin presumed due to familial metabolism will be considered on an individual basis)
  • Life expectancy greater than 3 years
  • Participants must agree to use adequate contraception (barrier method of birth control; abstinence) from time of screening until study completion (i.e., for at least 2 weeks after last dose of study drug)
  • Ability to understand and the willingness to sign a written informed consent document
  • Agree to refrain from use of selenium (Se) supplements (other than the 100 mcg dose common in multivitamins) or Se-containing drugs while on study between 30 days before study drug initiation and Day 84

Exclusion Criteria:

  • Not willing to remain at Roswell Park Cancer Institute (RPCI), and in follow up, as required
  • Presence of medical conditions which, in the opinion of the investigator, would place either the participant or the integrity of the data at risk
  • Serum creatinine > ULN, SGOT or SGPT >= 2.0 x ULN, or bilirubin > ULN
  • Treatment with an investigational drug within 30 days prior to the dose of study drug
  • Use of selenium [Se] supplements greater than the 100 mcg dose common in multivitamins between 30 days before study drug initiation and Day 84
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent (e.g., reaction to other Se supplements)
  • Participants who have donated 1 unit of blood within 30 days prior to the first dose of investigational agent
  • Eastern Cooperative Oncology Group (ECOG) performance status > 1
  • Diagnosed with cancer, other than non-melanoma skin cancer, in last 2 years
  • Under treatment for any cancer
  • Use of glucose-lowering agents or a condition that would make a fast from 10:00 pm the evening before until 11:00 am on days 1 and 84 hazardous
  • American Urological Association (AUA) total symptom score > 10 or any individual symptom score of greater than or equal to 4
  • Psychiatric illness which would prevent compliance with the intervention or would prevent the patient from providing informed consent
  • Medical conditions which in the opinion of the treating physician would make this protocol unreasonably hazardous for the participant

Sites / Locations

  • Northwestern University
  • Roswell Park Cancer Institute
  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm I (Se-methyl-seleno L-cysteine)

Arm II (selenomethionine)

Arm III (placebo)

Arm Description

Participants receive Se-methyl-seleno L-cysteine on days 1-84.

Participants receive selenomethionine PO on days 1-84.

Participants receive placebo PO on days 1-84.

Outcomes

Primary Outcome Measures

Clinical toxicity of Se-methyl-seleno-L-cysteine according to the NCI CTCAE version 4.0
The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.
Clinical toxicity of Se-methyl-L-cysteine compared to selenium after multiple doses, according to the NCI CTCAE version 4.0
The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.

Secondary Outcome Measures

Characterization of the pharmacokinetics of Se in the forms Se-methyl-seleno-L-cysteine and selenium at multiple doses
The pharmacokinetic variables will be tabulated, and descriptive statistics calculated for each cohort, using established pharmacokinetic analysis methods. Plasma and urine pharmacokinetic parameters will be summarized graphically and by arithmetic or geometric means and coefficients of variations for each cohort.

Full Information

First Posted
December 20, 2011
Last Updated
November 25, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01497431
Brief Title
Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants
Official Title
Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized phase I trial studies the side effects and the best dose of Se-methyl-seleno-L-cysteine or selenomethionine in preventing prostate cancer in healthy participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Se-methyl-seleno-L-cysteine or selenomethionine, two different types of selenium compounds, may prevent prostate cancer from forming.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the individual toxicity profiles of Se-methyl-seleno-L-cysteine (methyl selenocysteine; MSC) and selenomethionine (SeMet) administered to cohorts of men daily for twelve weeks, with dose escalation with each successive cohort. SECONDARY OBJECTIVES: I. To measure the pharmacokinetics of selenium, according to form (MSC vs SeMet): MSC and SeMet impacts on plasma, albumin, and urinary concentrations of selenium over 48 hours on dosing days 1 and 84. II. To evaluate the pharmacodynamics of selenium by form (MSC vs SeMet): plasma, albumin, and urinary Selenoprotein P (Sepp1) concentrations and glutathione peroxidase (GPx) activity over 48 hours on dosing days 1 and 84. III. To store plasma and formed elements (red cells plus platelets) for future analysis of methyl selenol and other key selenium species, when those assays become available. OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 3 treatment arms. ARM I: Participants receive Se-methyl-seleno-L-cysteine orally (PO) on days 1-84. ARM II: Participants receive selenomethionine PO on days 1-84. ARM III: Participants receive placebo PO on days 1-84. After completion of study treatment, patients are followed up on day 112.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
No Evidence of Disease, Prostate Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Se-methyl-seleno L-cysteine)
Arm Type
Experimental
Arm Description
Participants receive Se-methyl-seleno L-cysteine on days 1-84.
Arm Title
Arm II (selenomethionine)
Arm Type
Experimental
Arm Description
Participants receive selenomethionine PO on days 1-84.
Arm Title
Arm III (placebo)
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo PO on days 1-84.
Intervention Type
Dietary Supplement
Intervention Name(s)
Selenium
Other Intervention Name(s)
Se
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Methylselenocysteine
Other Intervention Name(s)
L-Se-Methylselenocysteine, Methylselenocycteine, MSC, Se-Methyl-seleno-L-cysteine, SeMSC
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Clinical toxicity of Se-methyl-seleno-L-cysteine according to the NCI CTCAE version 4.0
Description
The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.
Time Frame
Up to 112 days
Title
Clinical toxicity of Se-methyl-L-cysteine compared to selenium after multiple doses, according to the NCI CTCAE version 4.0
Description
The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.
Time Frame
Up to 112 days
Secondary Outcome Measure Information:
Title
Characterization of the pharmacokinetics of Se in the forms Se-methyl-seleno-L-cysteine and selenium at multiple doses
Description
The pharmacokinetic variables will be tabulated, and descriptive statistics calculated for each cohort, using established pharmacokinetic analysis methods. Plasma and urine pharmacokinetic parameters will be summarized graphically and by arithmetic or geometric means and coefficients of variations for each cohort.
Time Frame
At baseline, and at and .5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hrs after dosing on days 1 and between days 70 and 84

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Total body weight between 50 and 115 kg (110 and 250 lbs) Hemoglobin (Hgb) > 12 mg/dL Platelet count > 100,000/μL Absolute neutrophil count (ANC) > 1000/μL Creatinine =< institutional upper limit of normal (ULN) Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) < 2.0 x ULN Total bilirubin =< ULN (participants with a higher level of bilirubin presumed due to familial metabolism will be considered on an individual basis) Life expectancy greater than 3 years Participants must agree to use adequate contraception (barrier method of birth control; abstinence) from time of screening until study completion (i.e., for at least 2 weeks after last dose of study drug) Ability to understand and the willingness to sign a written informed consent document Agree to refrain from use of selenium (Se) supplements (other than the 100 mcg dose common in multivitamins) or Se-containing drugs while on study between 30 days before study drug initiation and Day 84 Exclusion Criteria: Not willing to remain at Roswell Park Cancer Institute (RPCI), and in follow up, as required Presence of medical conditions which, in the opinion of the investigator, would place either the participant or the integrity of the data at risk Serum creatinine > ULN, SGOT or SGPT >= 2.0 x ULN, or bilirubin > ULN Treatment with an investigational drug within 30 days prior to the dose of study drug Use of selenium [Se] supplements greater than the 100 mcg dose common in multivitamins between 30 days before study drug initiation and Day 84 History of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent (e.g., reaction to other Se supplements) Participants who have donated 1 unit of blood within 30 days prior to the first dose of investigational agent Eastern Cooperative Oncology Group (ECOG) performance status > 1 Diagnosed with cancer, other than non-melanoma skin cancer, in last 2 years Under treatment for any cancer Use of glucose-lowering agents or a condition that would make a fast from 10:00 pm the evening before until 11:00 am on days 1 and 84 hazardous American Urological Association (AUA) total symptom score > 10 or any individual symptom score of greater than or equal to 4 Psychiatric illness which would prevent compliance with the intervention or would prevent the patient from providing informed consent Medical conditions which in the opinion of the treating physician would make this protocol unreasonably hazardous for the participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Bergan
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants

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