Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Se-methyl-seleno-L-cysteine Dietary Supplement: selenium Other: placebo Other: laboratory biomarker analysis Other: pharmacological study |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine (MSC) and L SeMet in Adult Males |
- Clinical toxicity in healthy adult male volunteers according to the NCI CTCAE version 4.0 [ Time Frame: Up to 112 days ] [ Designated as safety issue: Yes ]
- Characterization of the pharmacokinetics of Se in the forms MSC and SeMet 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 84 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 66 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (low-dose treatment)
Participants receive Se-methyl-seleno L-cysteine, selenomethionine, or placebo at the first dose level PO on days 1-84.
|
Drug: Se-methyl-seleno-L-cysteine
Given PO
Other Names:
Dietary Supplement: selenium
Given PO
Other Name: Se
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Arm II (medium-dose treatment)
Participants receive Se-methyl-seleno-L-cysteine, selenomethionine, or placebo at the second dose level PO on days 1-84.
|
Drug: Se-methyl-seleno-L-cysteine
Given PO
Other Names:
Dietary Supplement: selenium
Given PO
Other Name: Se
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Arm III (high-dose treatment)
Participants receive Se-methyl-seleno-L-cysteine, selenomethionine, or placebo at the third dose level PO on days 1-84.
|
Drug: Se-methyl-seleno-L-cysteine
Given PO
Other Names:
Dietary Supplement: selenium
Given PO
Other Name: Se
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
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, selenomethionine, or placebo at the first dose level orally (PO) on days 1-84.
ARM II: Participants receive Se-methyl-seleno-L-cysteine, selenomethionine, or placebo at the second dose level PO on days 1-84.
ARM III: Participants receive Se-methyl-seleno-L-cysteine, selenomethionine, or placebo at the third dose level PO on days 1-84.
Participants undergo plasma and urine sample collection periodically for pharmacokinetic and pharmacodynamic studies. Samples are also stored for future proteomic and gene expression studies.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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 oxalo-acetic transaminase (SGOT) < 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
- Participants who have donated 1 unit of blood within 30 days prior to the first dose of investigational agent
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)
- 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
Contacts and Locations| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: James S. Marshall 716-845-8444 james.marshall@roswellpark.org | |
| Principal Investigator: James S. Marshall | |
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: James L. Mohler 716-845-8433 james.mohler@roswellpark.org | |
| Principal Investigator: James L. Mohler | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37240 | |
| Contact: Raymond Burk 615-343-6229 raymond.burk@vanderbilt.edu | |
| Principal Investigator: Raymond Burk | |
| Principal Investigator: | James Marshall | Northwestern University |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01497431 History of Changes |
| Other Study ID Numbers: | NCI-2012-00085, I 182210, CDR0000717828 |
| Study First Received: | December 20, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Selenium Selenomethylselenocysteine Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013