← Back to Search

Immunotherapy

Pre-Transplant Immunotherapy 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
Age of at least 18 years
Ability and willingness of the patient to participate in the study (Informed consent will be obtained)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at one, two and four years post-transplant.
Awards & highlights

Study Summary

This trial is investigating whether a combination of two drugs can help prevent skin cancer in people who have received organ transplants.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include skin irritation from both Calcipotriol and topical 5FU treatments such as redness, peeling, burning sensation at the application site; systemic effects might occur but are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am willing and able to participate in the study.
Select...
I am waiting for an organ transplant and have had skin cancer that was not melanoma.
Select...
I have 4 to 15 visible skin lesions on my head, face, or upper arms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for up to 4 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and for up to 4 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The changes in the percentage of participants with new SCC on treated anatomical sites in OTRs
Secondary outcome measures
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 (SCC number) 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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,773 Total Patients Enrolled
Washington University School of MedicineOTHER
1,928 Previous Clinical Trials
2,297,026 Total Patients Enrolled
Shadmehr Demehri, MD/PHDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

Calcipotriol and 5-fluorouracil cream (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04329221 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Topical Calcipotriol ointment plus 5-Fluorouracil cream, Topical vaseline plus 5-Fluorouracil 2.5% cream
Squamous Cell Carcinoma Clinical Trial 2023: Calcipotriol and 5-fluorouracil cream Highlights & Side Effects. Trial Name: NCT04329221 — Phase 2
Calcipotriol and 5-fluorouracil cream (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04329221 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Topical 5FU received endorsement from the Food and Drug Administration?

"Our team at Power assessed the safety of Topical 5FU to be a 2 on their 1-3 scale, as this is currently in Phase 2. While evidence indicates that it's safe, no data exists yet for its efficacy."

Answered by AI

What is the aggregate figure of participants in this research project?

"This trial is now closed and no longer recruiting patients. It was initially made available on January 1st 2023, but the last update to its listing was April 5th 2022. If you are searching for other studies involving immunotherapy, there are currently 853 trials that may be of interest; 326 clinical trials utilizing Topical 5FU in particular are presently looking for participants."

Answered by AI

What prior experiments have featured Topical 5FU as part of their protocol?

"At the moment, 326 trials involving Topical 5FU are in progress with 103 at Phase 3. Woolloongabba, Queensland features several of these clinical studies while a total 17193 locations have active assessments for this medication's efficacy."

Answered by AI

What medical conditions can be addressed by utilizing Topical 5FU?

"Ophthalmologists and general practitioners often prescribe 5FU topically for disinfecting the eyes or treating conditions such as dry eye syndromes, malignant neoplasm of pancreas and pruritus ani."

Answered by AI

Is there still room for individuals to participate in this experiment?

"Unfortunately, this trial is no longer looking to enroll participants as the last edit was made on April 5th 2022. However, if you are in search of other studies involving immunotherapy, there are 853 trials enlisting patients and 326 for Topical 5FU respectively."

Answered by AI
Recent research and studies
~41 spots leftby Jan 2029