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

Recruiting at 1 trial location

Overseen By Shadmehr Demehri, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Hypercalcemia, Vitamin D toxicity, DPD deficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

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 transplantation and determine whether it can prevent cutaneous squamous cell carcinoma (SCC) in OTRs post-transplant.

Who Is on the Research Team?

Shadmehr Demehri, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing and able to participate in the study.

I am waiting for an organ transplant and have had skin cancer that was not melanoma.

I have 4 to 15 visible skin lesions on my head, face, or upper arms.

Exclusion Criteria

I am a woman who cannot become pregnant or I have tested negative for pregnancy recently.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply topical Calcipotriol ointment plus 5-Fluorouracil cream to their face, scalp, and upper extremities twice a day for 6 consecutive days

1 week

No visits required during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in erythema extent and intensity

8 weeks

1 visit (in-person) at 1 day post-treatment, additional monitoring up to 2 months

Long-term Follow-up

Participants are monitored for the development of new SCCs and changes in immune response post-transplant

Up to 4 years post-transplant

What Are the Treatments Tested in This Trial?

Interventions

• Calcipotriol and 5-fluorouracil cream

Trial Overview 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.

How Is the Trial Designed?

Group I: Topical Calcipotriol ointment plus 5-Fluorouracil cream Experimental Treatment 2 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% cream Placebo Group 2 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+