Retinoid 9cUAB30 in Preventing Cancer in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subject

In brief

This randomized phase I trial studies the side effects and best dose of retinoid 9cUAB30 in preventing cancer in healthy volunteers. The use of retinoid 9cUAB30 may keep cancer from forming in healthy volunteers.

Key facts

Study ID

NCT01935960

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2013-08-01

Last updated by the study team

2016-12-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal volunteers, either male or female
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky >= 70%
• White blood cell (WBC) >= 3000/mm\^3
• Platelets >= 100,000/mm\^3
• Hemoglobin > 10 g/dL
• Bilirubin =< upper limit of institutional normal
• Aspartate aminotransferase (AST) =< upper limit of institutional normal
• Creatinine within institutional normal limits
• Sodium, potassium, chloride, bicarbonate: all =< upper limit of institutional normal
• Fasting triglycerides =< 1.5 x upper limit of normal (ULN)
• Fasting cholesterol =< 1.5 x ULN
• Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
• Heterosexual women and men must agree to use TWO effective forms of birth control for the duration of study participation and for 30 days following the last dose of study medication
• Men must agree not to donate sperm during the study and for three months after receiving the last dose of study drug
• The following persons are not considered to be able to father or bear children and therefore are eligible to participate without the use of concurrent birth control:
• Female with bilateral oophorectomy and/or hysterectomy
• Female with fallopian tubes cut, tied, or sealed
• Female with sterilization implant (e.g. Adiana, Essure) placed > 3 months prior to randomization
• Female post-menopausal (> 1 year since last menses)
• Male with vasectomy > 3 months prior to randomization
• One of the following methods of birth control must be used by women of childbearing potential:
• Combined oral contraceptive pill in continuous use for > 30 days prior to study entry
• Vaginal ring (e.g. NuvaRing) in continuous use for > 30 days prior to study entry
• Skin patch (e.g. Ortho Evra) in continuous use for > 30 days prior to study entry
• Injection (e.g. Depo-Provera, Noristerat) in continuous use for > 30 days prior to study entry

You may not qualify if…

• Participants may not be taking medications that might interact with 9cUAB30
• Participants may not be taking lipid lowering agents
• Participants may not receive any other investigational agents within 30 days of enrollment nor during study participation
• Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition of retinoids
• Participants with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Breastfeeding must be discontinued for the duration of study participation and for one month after the last dose of the study agent if the mother is treated with 9cUAB30
• Individuals known to be human immunodeficiency virus (HIV)-positive may not participate in this study
• Individuals with a history of cancer diagnosis or reoccurrence < 5 years from study entry may not participate; however, individuals with a history of squamous or basal cell carcinoma of the skin < 5 years from study entry will not be excluded from this study

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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