No Evidence of DiseasePhase 1NCT01497431
Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants
A Phase 1 study testing Selenium, Laboratory Biomarker Analysis and Pharmacological Study in people with No Evidence of Disease and Prostate Carcinoma, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- No Evidence of Disease, Prostate Carcinoma
- What is being tested?
- Selenium, Laboratory Biomarker Analysis and Pharmacological Study
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern University
Chicago, Illinois, 60611
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- No Evidence of Disease, Prostate Carcinoma
- Being tested
- Selenium, Placebo, Laboratory Biomarker Analysis, Pharmacological Study, Methylselenocysteine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
Also called Se
Given PO
PlaceboOther
Also called PLCB
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
MethylselenocysteineDrug
Also called L-Se-Methylselenocysteine, Methylselenocycteine, MSC, Se-Methyl-seleno-L-cysteine
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Se-methyl-seleno L-cysteine) | Experimental | Participants receive Se-methyl-seleno L-cysteine on days 1-84. Receives: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Methylselenocysteine |
| Arm II (selenomethionine) | Experimental | Participants receive selenomethionine PO on days 1-84. Receives: Dietary Supplement: Selenium; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
| Arm III (placebo) | Placebo comparator | Participants receive placebo PO on days 1-84. Receives: Other: Placebo; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 112 days
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.
Measured: Up to 112 days
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Raymond Bergan, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497431
- Sponsor's protocol ID
- NCI-2012-00085
- Other IDs
- NCI-2012-00085, CDR0000717828, I 182210, NWU09-4-03, P30CA060553, N01CN35157
- Status last verified
- Nov 2014
- First submitted
- 20 Dec 2011
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males
- ClinicalTrials.gov ID
- NCT01497431
- Acronym / sponsor ID
- NCI-2012-00085
- Conditions
- No Evidence of Disease, Prostate Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (Se-methyl-seleno L-cysteine) | Experimental | Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: MethylselenocysteineParticipants receive Se-methyl-seleno L-cysteine on days 1-84. |
| Arm II (selenomethionine) | Experimental | Dietary Supplement: Selenium, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyParticipants receive selenomethionine PO on days 1-84. |
| Arm III (placebo) | Placebo comparator | Other: Placebo, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyParticipants receive placebo PO on days 1-84. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeleniumAlso: SeGiven PO | Dietary supplement | Arm II (selenomethionine) |
| PlaceboAlso: PLCBGiven PO | Other | Arm III (placebo) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (Se-methyl-seleno L-cysteine), Arm II (selenomethionine), Arm III (placebo) |
| Pharmacological StudyAlso: pharmacological studiesCorrelative studies | Other | Arm I (Se-methyl-seleno L-cysteine), Arm II (selenomethionine), Arm III (placebo) |
| MethylselenocysteineAlso: L-Se-Methylselenocysteine, Methylselenocycteine, MSC, Se-Methyl-seleno-L-cysteineGiven PO | Drug | Arm I (Se-methyl-seleno L-cysteine) |
Primary outcome
Clinical toxicity of Se-methyl-seleno-L-cysteine according to the NCI CTCAE version 4.0
Time frame: Up to 112 days
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
Time frame: Up to 112 days
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.
1 secondary outcome
Characterization of the pharmacokinetics of Se in the forms Se-methyl-seleno-L-cysteine and selenium at multiple doses
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Bergan principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selenium, Laboratory Biomarker Analysis and Pharmacological Study in people with No Evidence of Disease and Prostate Carcinoma, run by National Cancer Institute (NCI) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical toxicity of Se-methyl-seleno-L-cysteine according to the NCI CTCAE version 4.0 (time frame: Up to 112 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.