Immunotherapy Creams for Skin Cancer Prevention in Organ Transplant Recipients

Recruiting at 1 trial location

Overseen By Shadmehr Demehri, MD/ PHD

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: 7

Duration: 1 week

Trial Summary

What is the purpose of this trial?

This trial tests if two creams can help organ transplant patients fight off early skin cancer. One cream boosts immune cells, and the other kills abnormal cells. The goal is to see if this combination can prevent skin cancer in these high-risk patients. A commonly used medication to prevent organ rejection is associated with an increased risk of skin cancer.

Research Team

Shadmehr Demehri, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for organ transplant recipients aged 18 or older with 4-15 visible actinic keratoses on certain body areas and a history of non-melanoma skin cancer within the last year. It's not for those with healing wounds, unresponsive lesions, DPD deficiency, hypercalcemia, or women who could be pregnant.

Inclusion Criteria

The period between the first visit and transplantation is minimum 4 weeks and maximum 12 months.

I had a solid organ transplant, have AKs, and had skin cancer within the last year.

I have 4-15 visible skin lesions on my scalp, face, or arms.

Exclusion Criteria

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

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 week

1 visit (in-person) for initial application guidance

Follow-up

Participants are monitored for changes in actinic keratoses and squamous cell carcinoma prevention, as well as treatment-related adverse events

8 weeks

2 visits (in-person) at 1 day and 8 weeks post-treatment

Long-term Follow-up

Participants are monitored for long-term changes in squamous cell carcinoma prevention and immune response

4 years

Annual visits (in-person) for up to 4 years post-treatment

Treatment Details

Interventions

• Calcipotriol and 5-FU cream

Trial Overview The study tests if Calcipotriol ointment combined with 5-FU cream can prevent squamous cell carcinoma by activating immune cells against precancerous skin lesions in organ transplant recipients.

Participant Groups

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+