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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Selenium; Selenomethylselenocysteine

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