What side effects are associated with this type of intervention?

Common treatments for skin cancer that involve immune modulation and DNA synthesis inhibition include calcipotriol and 5-fluorouracil (5-FU). Calcipotriol, a vitamin D analog, can cause local skin irritation, erythema, and pruritus. 5-FU, a chemotherapeutic agent, often leads to side effects such as severe local inflammation, pain, erythema, erosion, and ulceration at the application site. Both treatments may result in significant discomfort, leading to reduced application frequency or discontinuation.

What prior FDA approvals exist?

The FDA has approved several treatments for skin cancer that involve immune modulation and DNA synthesis inhibition. Imiquimod, an immune response modifier, is approved for the treatment of superficial basal cell carcinoma and actinic keratosis. 5-Fluorouracil (5-FU), a pyrimidine analog that inhibits DNA synthesis, is approved for actinic keratosis and superficial basal cell carcinoma. These treatments work by stimulating the immune system to target cancer cells or by directly interfering with DNA replication in rapidly dividing cells.

What other types of research exist?

Promising novel alternatives for skin cancer treatment include: 1) Anti-CTGF oligonucleotide (EXC 001), which reduces hypertrophic scars post-surgery by suppressing CTGF. 2) Compound C (CompC), which inhibits tumor growth by blocking cell cycle progression and angiogenesis. 3) Second-generation somatostatin-dopamine chimera (TBR-065), which shows significant anti-tumor activity in medullary thyroid cancer and may have potential in skin cancer. 4) Photodynamic therapy combined with topical interventions, which has shown efficacy in treating actinic keratosis and may be applicable to skin cancer.

← Back to Search

Immunotherapy

Immunotherapy Creams 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

Solid organ transplant recipients with AKs and a history of non-melanoma skin cancer in one year prior to enrollment into the study. The target population includes post-transplant OTRs.

Presence of four to fifteen clinically typical, visible, and discrete AKs in 25 cm2 on any of the four anatomical sites: scalp, face, right upper extremity and left upper extremity.

Must not have

Female participants must be either of non-reproductive potential (i.e., post-menopausal by history of age > 50 years old and no menses for >1 year without an alternative medical cause; OR history of hysterectomy, history of bilateral tubal ligation, or history of bilateral oophorectomy) OR must have a negative serum pregnancy test within 7 days prior to study registration.

Patients with DPD (Dihydropyrimidine Dehydrogenase) deficiency (due to their higher risk of 5-FU toxicity).

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation, redness, and peeling from the topical treatments. There's also a risk of systemic absorption leading to fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

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

Select...

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

Select...

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

Select...

My skin has thick, rough patches or growths that haven't improved with freezing treatments.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at one, two and four 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 baseline number of AKs on treated anatomical sites in post-transplant 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 (number of SCC) 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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for skin cancer often involve mechanisms such as immune modulation and DNA synthesis inhibition. Calcipotriol, a vitamin D analog, modulates the immune system by enhancing the body's immune response against cancer cells, making it harder for these cells to survive and proliferate. 5-Fluorouracil (5-FU) inhibits DNA synthesis by blocking the enzyme thymidylate synthase, which is crucial for DNA replication. This leads to the death of rapidly dividing cancer cells. These mechanisms are crucial for skin cancer patients as they target the cancer cells directly, either by boosting the body's natural defenses or by disrupting the cancer cells' ability to multiply, thereby reducing tumor growth and preventing the spread of cancer.

Topical calcipotriol combined with phototherapy for psoriasis. The results of two randomized trials and a review of the literature. Calcipotriol-UVB Study Group.