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Immunotherapy

Pre-Transplant Immunotherapy for Skin Cancer Prevention in Organ Transplant Recipients

Phase 2
Waitlist Available
Led By Shadmehr Demehri, MD/PHD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of at least 18 years
Solid organ transplant candidates with AKs and a history of non-melanoma skin cancer including kidney, lung, liver, and heart transplantations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at one, two and four years post-transplant.
Awards & highlights

Study Summary

This trial is investigating whether a combination of two drugs can help prevent skin cancer in people who have received organ transplants.

Who is the study for?
This trial is for organ transplant candidates aged 18+ with actinic keratosis and a history of non-melanoma skin cancer. They must have 4-15 visible AKs on certain body areas and be within 4 weeks to 12 months of transplantation. Excluded are those with wounds, suspected carcinomas near the treatment area, DPD deficiency, hypercalcemia or vitamin D toxicity history, hypertrophic lesions, or women who could become pregnant.Check my eligibility
What is being tested?
The study tests if Calcipotriol ointment combined with topical 5-fluorouracil (5FU) cream can prevent squamous cell carcinoma in organ transplant recipients by treating actinic keratosis before transplantation. Vaseline serves as a control comparison.See study design
What are the potential side effects?
Potential side effects include skin irritation from both Calcipotriol and topical 5FU treatments such as redness, peeling, burning sensation at the application site; systemic effects might occur but are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am waiting for an organ transplant and have had skin cancer that was not melanoma.
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I have 4 to 15 visible skin lesions on my head, face, or upper arms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for up to 4 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and for up to 4 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The changes in the percentage of participants with new SCC on treated anatomical sites in OTRs
Secondary outcome measures
Number of Participants with Treatment Related Adverse Events
Number of participants with any proven rejection of the graft in OTRs
The changes in SCC prevention (SCC number) on the untreated anatomical sites (i.e., trunk and lower extremities) of OTRs
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical Calcipotriol ointment plus 5-Fluorouracil creamExperimental Treatment2 Interventions
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.
Group II: Topical vaseline plus 5-Fluorouracil 2.5% creamPlacebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,946 Previous Clinical Trials
13,204,562 Total Patients Enrolled
Washington University School of MedicineOTHER
1,945 Previous Clinical Trials
2,303,409 Total Patients Enrolled
Shadmehr Demehri, MD/PHDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

Calcipotriol and 5-fluorouracil cream (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04329221 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Topical Calcipotriol ointment plus 5-Fluorouracil cream, Topical vaseline plus 5-Fluorouracil 2.5% cream
Squamous Cell Carcinoma Clinical Trial 2023: Calcipotriol and 5-fluorouracil cream Highlights & Side Effects. Trial Name: NCT04329221 — Phase 2
Calcipotriol and 5-fluorouracil cream (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04329221 — Phase 2
~41 spots leftby Jan 2029
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