Fenretinide Patch for Oral Leukoplakia

(FMS Trial)

Overseen By Daren Wang, DDS, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University

Disqualifiers: Oscc history, Cancer treatments, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using a patch that releases fenretinide, a vitamin A derivative, to determine if it can reduce precancerous changes in the mouth's lining. The study will assess whether the patch can shrink these areas, improve their microscopic appearance, and lower the risk of progression to cancer. Individuals with a confirmed precancerous spot in the mouth who do not use tobacco products may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that you stop using tobacco products for 6 weeks before and during the study.

What prior data suggests that this mucoadhesive fenretinide-releasing system is safe for oral use?

Earlier studies have shown that fenretinide, the main ingredient in the mucoadhesive patch, is well-tolerated. Research on similar treatments indicates that side effects are rare and usually mild. Some participants reported slight irritation at the application site, but no serious side effects emerged. This suggests that the fenretinide patch is likely safe for humans. As this trial is in the early stages, the primary goal is to assess safety, and any possible risks are being closely monitored. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for oral leukoplakia, typically involving surgical removal, laser therapy, or cryotherapy, the mucoadhesive fenretinide-releasing system (FMS) offers a unique approach. FMS is exciting because it delivers fenretinide directly to the affected area through a patch, potentially reducing systemic side effects and increasing the effectiveness of the treatment. This targeted delivery system may enhance the ability to manage premalignant oral epithelial lesions more efficiently and comfortably than traditional methods. Researchers are eager to see if this localized approach can provide a safer, more effective treatment option for patients.

What evidence suggests that the mucoadhesive fenretinide-releasing system is effective for oral leukoplakia?

Research has shown that fenretinide, a form of vitamin A, might help prevent oral cancer. In this trial, participants will use a mucoadhesive fenretinide-releasing system (FMS), a special patch that adheres to the gum to deliver fenretinide effectively to the mouth. This patch enhances the absorption of fenretinide into the mouth tissue. Early findings suggest that fenretinide may reduce harmful cell changes that could lead to cancer. Although more research is needed, these initial results are promising for reducing precancerous changes in the mouth. ^{1 2 3 4 6}

Who Is on the Research Team?

Susan R. Mallery, DDS, PhD

Principal Investigator

Ohio State University College of Dentistry

Are You a Good Fit for This Trial?

Adults with precancerous oral lesions, specifically leukoplakia, who have not yet developed cancer. Participants must be healthy enough for minor surgical procedures like wisdom tooth removal and biopsies. They should not have any conditions that would interfere with the study or pose a risk to their health.

Inclusion Criteria

I agree to use contraception during and 1 month after treatment. I understand the need for monthly pregnancy tests if applicable.

I am an adult with a confirmed OIN lesion larger than 3x3 mm that can be fully covered by the FMS.

Available for follow-up evaluations, amenable to full 6-week study participation, and 6-week post-study recall

Exclusion Criteria

I am unable to understand and give consent for treatment.

My biopsy shows early-stage oral cancer.

I have had oral squamous cell carcinoma before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Dose Pharmacokinetic Assessment

Single FMS application to determine the requisite length of patch application time needed to achieve the predetermined fenretinide levels.

20 minutes

1 visit (in-person)

Multi-dose Chemoprevention Evaluation

Participants apply FMS to OIN lesions twice daily for 6 weeks, with regular monitoring and assessments.

6 weeks

6 visits (in-person, every 7-10 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final clinical assessment.

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mucoadhesive fenretinide-releasing system (FMS)

Trial Overview The trial is testing a mucoadhesive patch called FMS that releases fenretinide, aiming to reduce the size and severity of precancerous changes in mouth lining tissue. The study has two parts: one involving a single application on people having wisdom teeth removed, and another where patients apply the patch twice daily for six weeks.

How Is the Trial Designed?

Group I: FMS impact on premalignant oral epithelial lesions Experimental Treatment 1 Intervention

Evaluation of the impact of the fenretinide-releasing system on premalignant oral epithelial lesions

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07149220

Fenretinide Mucoadhesive Patch: Evaluation of Oral ... The goal of this clinical trial is to determine the effect of a mucoadhesive system that releases the vitamin A derivative, fenretinide (FMS), ...

2. reporter.nih.gov reporter.nih.gov/project-details/10885898

Project Details - NIH RePORTER Assessment of Chemopreventive Effects of a Mucoadhesive Fenretinide Patch on Premalignant Oral Epithelial Lesions. Project Number5R01CA227273-06. Contact PI ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3687357/

Mucoadhesive Fenretinide Patches for Site-specific ... The objective of this study was to enhance oral mucosal permeation of fenretinide by co-incorporation of propylene glycol (PG) and menthol in fenretinide/ ...

4. mdpi.com mdpi.com/2072-6694/13/15/3845

Early-Phase Interventional Trials in Oral Cancer Prevention This paper will explore current evidence in oral cancer chemoprevention, drug repurposing, selection of appropriate endpoints for early-phase trials and novel ...

5. joms.org joms.org/article/S0278-2391(11)00904-9/fulltext

Mucoadhesive Patch for Local Intraoral Delivery of the ... Conclusion. These data suggest successful delivery of therapeutically-relevant levels of fenretinide to the rabbit buccal mucosa. Characterization of the human ...

6. researchgate.net researchgate.net/publication/51220240_Development_and_In_Vitro-In_Vivo_Evaluation_of_Fenretinide-Loaded_Oral_Mucoadhesive_Patches_for_Site-Specific_Chemoprevention_of_Oral_Cancer

Development and In Vitro-In Vivo Evaluation of Fenretinide ... To develop fenretinide oral mucoadhesive patch formulations and evaluate their in vitro and in vivo release performance for future site-specific ...