Status:
WITHDRAWN
Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Cutaneous Squamous Cell Carcinoma
Actinic Keratoses
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This clinical trial aims to investigate the efficacy of Calcipotriol ointment combined with 5-fluorouracil cream as an immunotherapy for actinic keratosis in Organ Transplant Recipients (OTRs) before ...
Detailed Description
The main goal of this investigator-initiated clinical trial is to determine the efficacy of topical calcipotriol combined with 5-flourouracil (5-FU) treatment in organ transplant candidates with preca...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04329221
Start Date
January 1 2026
End Date
January 1 2030
Last Update
May 7 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
2
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63108