Status:
COMPLETED
Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
No Evidence of Disease
Prostate Carcinoma
Eligibility:
MALE
40-80 years
Phase:
PHASE1
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 th...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01497431
Start Date
November 1 2011
End Date
July 1 2014
Last Update
November 26 2014
Active Locations (3)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
3
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232