Immunotherapy Creams for Skin Cancer Prevention in Organ Transplant Recipients

No longer recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two creams to determine their effectiveness in preventing skin cancer in individuals who have undergone organ transplants. The creams aim to boost immune cells to combat pre-cancerous skin spots. One group will use a combination of Calcipotriol and 5-FU cream (a type of immunotherapy), while the other will use 5-FU cream with Vaseline. Individuals who have had an organ transplant and experienced certain skin issues, such as multiple actinic keratoses (rough, scaly patches) in the past year, may be suitable for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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?

Research has shown that using a combination of calcipotriol and 5-FU cream on the skin is generally safe. Calcipotriol, a form of vitamin D, effectively prevents skin cancer when applied topically. 5-FU cream treats damaged skin cells and is well-studied in skin care. Both treatments are usually well-tolerated, with side effects such as mild skin irritation, redness, or peeling. These effects are temporary and resolve after treatment. This suggests that calcipotriol and 5-FU cream could be good options for preventing skin cancer in organ transplant recipients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about these treatments because they offer a unique approach for preventing skin cancer in organ transplant recipients. Unlike standard treatments that primarily focus on surgical or systemic therapies, these topical creams combine calcipotriol and 5-fluorouracil (5-FU), which work together to enhance the immune response directly in the skin. Calcipotriol, a vitamin D analog, helps modulate the immune system, while 5-FU is a well-known chemotherapy agent that targets abnormal skin cells. This combination not only targets potential cancerous cells but also boosts the skin's natural defense mechanisms, potentially providing a more effective and less invasive prevention strategy. Moreover, the treatment is applied directly to the skin and shows promising results in just six days, which is significantly quicker than many existing options.

What evidence suggests that Calcipotriol and 5-FU cream might be an effective treatment for skin cancer prevention in organ transplant recipients?

Research has shown that Calcipotriol ointment combined with 5-FU cream can effectively treat precancerous skin spots. In this trial, participants will receive either the combination of Calcipotriol ointment and 5-Fluorouracil cream or a placebo comparator of Vaseline and 5-Fluorouracil cream. Studies indicate that Calcipotriol and 5-FU work together to strengthen the immune system, aiding in the fight against these spots. This combination has been particularly successful in removing actinic keratoses, which are precancerous spots that might develop into skin cancer. While 5-FU is already known for treating these spots, Calcipotriol enhances its effectiveness by boosting the immune response. These early findings suggest that this treatment could help prevent skin cancer in individuals who have undergone organ transplants. ^{2 4 6 7 8}

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 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 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 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

What Are the Treatments Tested in This Trial?

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.

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. 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.

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

Topical treatment of actinic keratoses in organ transplant ... 5‐FU was more effective than IMIQ in AK clearance and prevention in exploratory analyses. Although toxicity was greater with 5‐FU, HRQoL ...

4. 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 ...

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

Cancer-Preventing Topical Immunotherapy Trains ... Clinical trial results detail how topical calcipotriol plus 5-fluorouracil (5-FU) leverages the adaptive immune system to eliminate precancerous lesions and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04642287

Immunotherapy After Transplantation for Skin Cancer ... This clinical trial aims to investigate the efficacy of Calcipotriol ointment combined with 5-FU cream in Organ Transplant Recipients (OTRs) to determine if ...

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.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05699603/testing-the-efficacy-of-topical-calcipotriene-plus-5-fluorouracil-combination-to-activate-the-immune-system-against-precancerous-skin-lesions-in-organ-transplant-recipients

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.