Status:
WITHDRAWN
A Biomarker Evaluation Trial of UAB30 in Renal Transplant Recipients at High Risk for Non-melanoma Skin Cancer
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Non-melanoma Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled biomarker study in renal transplant recipients with actinic damage and a history of basal cell carcinomas and/or cutaneous squamous cell carcinom...
Detailed Description
Non-melanoma skin cancers (NMSCs), which include basal cell carcinomas (BCCs) and cutaneous squamous carcinomas (SCCs), are the most common malignancy in the U.S.; it is estimated that \>3.5 million n...
Eligibility Criteria
Inclusion
- ≥18 years of age.
- Potential subjects will have at least 8 actinic keratoses (as determined by study dermatologists or qualified designee ).
- ECOG performance status of 0 or 1.
- Participants must have normal organ and marrow function as defined below:
- WBC ≥ 3000/mm3; platelets ≥ 100,000mm3, hemoglobin \>10 g/dL
- Bilirubin ≤ upper limit of institutional normal
- Creatinine within institutional normal limits
- Sodium, Potassium, Chloride, Bicarbonate: all ≤ upper limit of institutional normal
- Fasting Triglycerides ≤1.5xULN and Fasting Cholesterol ≤1.5x ULN
- Women of child-bearing potential and men must agree to use two effective forms of birth control prior to study entry and for the duration of study participation and for one month after study completion. Low dose progesterone only birth control pills are not an acceptable form of birth control due to lowered birth control efficacy with retinoids. Males who have had a vasectomy are not considered able to father a child, and therefore are eligible to participate without the use of concurrent birth control. Women who have had a bilateral oophorectomy, hysterectomy, or are greater than 1 year since their last menses, are not considered to be of child-bearing potential, and therefore are eligible to participate without the use of concurrent birth control.
- Each of the following is considered to be a single effective method of birth control:
- Combined oral contraceptive pill if used for \>30 days prior to entry into the study and continued for 30 days after the last dose of the study agent.
- Implanted hormone if in place for \>30 days prior to entry into the study and continued for 30 days after the last dose of the study agent.
- Any implanted device
- Vasectomy
- Tubal ligation
- 2 barrier methods used together
- cervical cap + spermacide or foam
- diaphragm + spermacide or foam
- condom + spermacide or foam
- Females of child-bearing potential must have two negative urine pregnancy tests before starting drug; the first at the time of screening and a second pregnancy test within the first 5 days of their menstrual period.
- Participants must have the ability to understand, and the willingness to sign, a written informed consent document.
Exclusion
- Participants may not be taking medications which might interact with UAB30.
- Participants may not be taking lipid lowering agents.
- Participants may not be receiving any other investigational agents.
- 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, recurrent or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Depression is not exclusionary, but the investigator should make the determination if patients with depression are eligible.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with UAB30, 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 UAB30.
- Individuals known to be HIV-positive may not participate in this study. The uncertain immune status of HIV-positive people and the potential risks of taking part in this study are too great to justify a study with low likelihood of benefit
- 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.
- Because of the uncertain risk of UAB30 to unborn fetuses and children, pregnant women and children will not be allowed in this study
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03327064
Start Date
October 1 2020
End Date
August 31 2023
Last Update
August 7 2024
Active Locations (1)
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1
UAB Dermatology
Birmingham, Alabama, United States, 35233