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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at one, two and four years post-transplant.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My treatment area is close to a healing wound or a possible skin cancer.

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I have skin growths that are thick, rough, or didn't improve with freezing treatments.

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I have had high calcium levels or vitamin D toxicity in the past.

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I have a DPD deficiency, increasing my risk for certain medication toxicities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for up to 4 years post-transplant

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The changes in the percentage of participants with new SCC on treated anatomical sites in OTRs

Secondary study objectives

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.

0 / 7Eligibility criteria met