A Biomarker Evaluation Trial of UAB30 in Renal Transplant Recipients at High Risk for Non-melanoma Skin Cancer
Non-melanoma Skin Cancer
About this trial
This is an interventional treatment trial for Non-melanoma Skin Cancer
Eligibility Criteria
Inclusion Criteria:
- ≥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 Criteria:
- 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
Sites / Locations
- UAB DermatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Renal Transplant subjects receiving UAB30
Renal Transplant subjects receiving placebo
Generally healthy renal transplant subjects receive UAB30 for 28 days with increased risk of non-melanoma skin cancer as evidenced by a history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses and presence at baseline of at least 8 actinic keratosis on the face, neck, scalp and arms.
Generally healthy renal transplant subjects receive placebo for 28 days with increased risk of non-melanoma skin cancer as evidenced by a history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses and presence at baseline of at least 8 actinic keratosis on the face, neck, scalp and arms.