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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at one, two and four years post-transplant.
Awards & highlights
Study Summary
This trial will investigate if a combination of two creams can help prevent skin cancer in people who have had an organ transplant.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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.
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 baseline number of AKs on treated anatomical sites in post-transplant 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 (number of SCC) on the untreated anatomical sites (i.e., trunk and lower extremities) of OTRs
+5 moreTrial 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
2,929 Previous Clinical Trials
13,198,241 Total Patients Enrolled
Washington University School of MedicineOTHER
1,933 Previous Clinical Trials
2,299,661 Total Patients Enrolled
Shadmehr Demehri, MD/PHDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
62 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.My treatment area is close to a healing wound or a possible skin cancer spot.My skin has thick, rough patches or growths that haven't improved with freezing treatments.I am 18 years old or older.I am willing and able to participate in the study.I have had high calcium levels or vitamin D toxicity in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Topical vaseline plus 5-Fluorouracil 2.5% cream
- Group 2: Topical Calcipotriol ointment plus 5-Fluorouracil cream
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals being accepted to join this trial at the present moment?
"The clinicaltrials.gov database shows that this medical trial, posted on January 1st 2023, has ceased recruitment as of April 5th 2022. Nevertheless, there are 1179 other studies actively enrolling patients at the moment."
Answered by AI
What conditions make the topical application of 5FU a preferred treatment choice?
"Topical 5FU is a viable option for treating ocular disinfection, dry eye syndromes, and malignant neoplasm of the pancreas."
Answered by AI
Are there any recorded precedents of trials using Topical 5FU?
"Presently, there are 326 active clinical trials exploring the efficacy of Topical 5FU with 103 in Phase 3. Some investigations are based out of Adelaide, South Australia; however, this medication is being studied across 17,913 clinics worldwide."
Answered by AI
Has the Food and Drug Administration sanctioned Topical 5FU for therapeutic use?
"Due to its Phase 2 status, there is some evidence indicating Topical 5FU's security, thus earning it a rating of 2. Nevertheless, the efficacy of this medication has yet to be confirmed."
Answered by AI
How many participants are being enlisted for this experiment?
"This trial is no longer accepting candidates, as the last edit was made on April 5th 2022. However, there are 853 clinical trials looking for participants with immunotherapy and 326 studies which use Topical 5FU that have open call-outs."
Answered by AI
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