Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients
Cutaneous Squamous Cell Carcinoma, Actinic Keratoses, Skin Cancer
About this trial
This is an interventional prevention trial for Cutaneous Squamous Cell Carcinoma focused on measuring Calcipotriol ointment, 5-FU cream, Squamous Cell Carcinoma, Actinic Keratoses, Organ Transplant Recipients, Prevention, Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Solid organ transplant candidates with AKs and a history of non-melanoma skin cancer. The target population includes the patients who are undergoing kidney, lung, liver and heart transplantations.
- Presence of four to fifteen clinically typical, visible, and discrete AKs in 25 cm2 on any of the four anatomical sites: scalp, face, right upper extremity and left upper extremity.
- The period between the first visit and transplantation is minimum 4 weeks and maximum 12 months.
- Age of at least 18 years
- Ability and willingness of the patient to participate in the study (Informed consent will be obtained)
Exclusion Criteria:
- Treatment area is within 5 cm of an incompletely healed wound or a suspected basal cell or squamous cell carcinoma.
- Treatment area contained hypertrophic and hyperkeratotic lesions, cutaneous horns, or lesions that had not responded to repeated cryotherapy.
- Patients with history of hypercalcemia or vitamin D toxicity.
- Female participants must be either of non-reproductive potential (i.e., post-menopausal by history of age > 50 years old and no menses for >1 year without an alternative medical cause; OR history of hysterectomy, history of bilateral tubal ligation, or history of bilateral oophorectomy) OR must have a negative serum pregnancy test within 7 days prior to study registration.
- Patients with DPD (Dihydropyrimidine Dehydrogenase) deficiency (due to their higher risk of 5-FU toxicity).
Sites / Locations
- Massachusetts General Hospital
- Barnes-Jewish Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Topical Calcipotriol ointment plus 5-Fluorouracil cream
Topical vaseline plus 5-Fluorouracil 2.5% cream
Topical Calcipotriol 0.0025% ointment plus 5-Fluorouracil 2.5% cream will be administered by the participants to their face, scalp and upper extremities twice a day for 6 consecutive days.
Topical Vaseline plus 5-Fluorouracil 2.5% cream will be administered by the participants to their face, scalp and upper extremities twice a day for 6 consecutive days.