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Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine (MSC) and L SeMet in Adult Males


Phase 1
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine (MSC) and L SeMet in Adult Males


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Clinical toxicity in healthy adult male volunteers according to the NCI CTCAE version 4.0

Outcome Time Frame:

Up to 112 days

Safety Issue:

Yes

Principal Investigator

James Marshall

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-00085

NCT ID:

NCT01497431

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Northwestern UniversityChicago, Illinois  60611