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Photosensitizer

PDT for Basal Cell Carcinoma

Phase 2

Recruiting

Led By Edward V Maytin, MD, PhD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults scheduled to undergo Mohs surgery within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic

Must have at least one BCC tumor eligible for removal by surgical excision

Must not have

Currently being treated for other cancers with medical or radiation therapy

History of a photosensitivity disease, e.g., porphyria cutanea tarda

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at visit 1 (pre pdt) and visit 2 (1-14 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand how the immune system responds to basal cell carcinoma after it's been treated with Photodynamic Therapy. This could potentially lead to new ways to fight the cancer.

Who is the study for?

This trial is for adults with at least two basal cell carcinoma (BCC) tumors that are scheduled for Mohs surgery at the Cleveland Clinic's Dermatology Department. Participants must consent to join and can be of any ethnic group. Pregnant or breastfeeding individuals, those treated for other cancers, allergic to ALA, or with a photosensitivity disease cannot participate.

What is being tested?

The study aims to understand how Photodynamic Therapy (PDT) using ALA affects the immune response against BCC and could improve tumor removal when combined with other treatments. It will help develop new strategies for treating BCC by studying changes in the immune microenvironment post-PDT.

What are the potential side effects?

While not explicitly listed here, common side effects of PDT may include skin redness, swelling, pain at the treatment site, and sensitivity to light. Allergic reactions to ALA might occur but participants with known hypersensitivity are excluded.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for Mohs surgery at Cleveland Clinic's Dermatology Department.

Select...

I have at least one skin cancer tumor that can be surgically removed.

Exclusion Criteria

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

Select...

I am currently receiving treatment for another cancer.

Select...

I have a condition that makes my skin sensitive to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at visit 1 (pre pdt) and visit 2 (1-14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at visit 1 (pre pdt) and visit 2 (1-14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at visit 1 (pre pdt) and visit 2 (1-14 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Altered expression of immune checkpoint molecules

Altered recruitment of different immune cell subtypes in BCC tumor specimens

Time to maximum expression of immune checkpoint molecules

Secondary study objectives

Change in the appearance of tumors

Change in the color of tumors

Change in the volume of tumors

+5 more

Side effects data

From 2010 Phase 2 trial • 107 Patients • NCT00933543

50%

Pain

48%

Erythema

26%

Pruritus

22%

Skin burning sensation

19%

Nasopharyngitis

17%

Paraestehesia

Facial pain

Skin irritation

Feeling hot

100%

80%

60%

40%

20%

Study treatment Arm

Visonac Cream With PDT

Vehicle Cream With PDT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Photodynamic therapy (PDT)Experimental Treatment2 Interventions

Each participant will serve as their own control, receiving PDT for one tumor, no PDT for the second tumor (untreated control). Visit 1: * Informed consent * Blood draw * Lesion(s) Photographed * (ALA) applied for4 hours * PpIX measured in lesions (PpIX buildup monitored every 30 minutes over a 4 h period) * PDT with blue light Visit 2 (scheduled for within one of the following time intervals: 1-3 days, 4-7 days, or 8-14 days post-PDT): * Blood draw * Lesion(s) Photographed * Mohs surgery * After procedure, excess frozen BCC tissue will be saved for analysis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PDT

2013

Completed Phase 4

~350

ALA

2018

Completed Phase 2

~330