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

No longer recruiting at 2 trial locations

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 trial tests a cream-based treatment to prevent skin cancer in individuals about to undergo an organ transplant. The treatment combines Calcipotriol ointment and 5-fluorouracil cream to address actinic keratosis (scaly skin patches that can become cancerous) before the transplant. It targets those with a history of non-melanoma skin cancer and visible actinic keratosis on the face, scalp, or arms. Participants will apply the cream to these areas for six days. Ideal candidates are those scheduled to receive a kidney, lung, liver, or heart transplant within 4 weeks to a year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that combining calcipotriol ointment with 5-fluorouracil cream safely treats early signs of skin cancer. Research indicates that this treatment can help prevent squamous cell carcinoma, a type of skin cancer, without causing serious side effects. Most patients tolerated the treatment well. Some experienced minor skin irritation, such as redness or peeling, but these effects were usually mild and temporary. This suggests that the treatment is generally well-tolerated and could be a promising option for those seeking to prevent skin cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin cancer prevention?

Researchers are excited about using Calcipotriol and 5-fluorouracil cream together because this combo could offer a new way to prevent skin cancer in organ transplant recipients, who are at higher risk for this type of cancer. Unlike standard treatments like surgical removal or cryotherapy, this approach uses a topical application that targets the skin directly. Calcipotriol boosts the immune system's response to abnormal skin cells while 5-fluorouracil works to kill those cells, potentially offering a dual-action strategy that is both preventive and therapeutic. This combination is promising because it could provide a non-invasive, easy-to-apply option for patients who need vigilant skin cancer prevention.

What evidence suggests that Calcipotriol and 5-fluorouracil cream might be an effective treatment for actinic keratosis in organ transplant recipients?

In this trial, participants will receive either a combination of calcipotriol (a form of vitamin D) and 5-fluorouracil (a type of chemotherapy) or a placebo comparator. Research has shown that using calcipotriol with 5-fluorouracil effectively treats actinic keratosis, which are skin spots that can lead to cancer. Studies have found that this combination not only clears existing spots but also helps prevent new ones. For individuals who have had organ transplants and face a higher risk of skin cancer, this treatment might help prevent cutaneous squamous cell carcinoma. Previous research suggests that this combination aids the immune system in fighting these precancerous spots. Overall, promising evidence indicates it can help prevent skin cancer in at-risk individuals. ^{1 2 3 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05699603

Study Details | NCT05699603 | Testing the Efficacy of ... This phase IIA study evaluates the effects of calcipotriene plus 5- fluorouracil immunotherapy for skin cancer prevention in organ transplant recipients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04329221

Immunotherapy Before Transplantation for Skin Cancer ... This clinical trial aims to investigate the efficacy of Calcipotriol ointment combined with 5-fluorouracil cream as an immunotherapy for actinic keratosis ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00310

Testing the Efficacy of Topical calcipotriene plus 5- ... This phase IIA study evaluates the effects of calcipotriene plus 5- fluorouracil immunotherapy for skin cancer prevention in organ transplant recipients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9543168/

Topical treatment of actinic keratoses in organ transplant ... AK activity analyses found 5‐FU and IMIQ were superior to sunscreen for AK clearance and prevention of new AKs. 5‐FU was more effective than ...

5. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/articles/topical-immunotherapy-trains-immune-system-to-fight-precancers

Cancer-Preventing Topical Immunotherapy Trains ... Recently, researchers found that using a vitamin D analog (calcipotriol) combined with chemotherapy (5-FU) can eliminate precancerous spots and ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/mass-general-brigham-trial/

Mass General Brigham reports results of skin cancer ... The therapy combines topical calcipotriol with 5-fluorouracil (5-FU) and has been shown to eliminate precancerous lesions and prevent squamous cell carcinoma ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5199703/

Randomized trial of calcipotriol combined with 5- ... This discovery highlights the potential of calcipotriol as an effective and safe topical agent for skin cancer immunotherapy and prevention.