PDT for Basal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

Overseen by Edward Maytin, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Pregnant, Other cancers, Photosensitivity, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to better understand the immune response to basal cell carcinoma (BCC) treated with Photodynamic Therapy (PDT) in order to develop new methods of treating BCC. Previous research suggests that PDT alters the immune response, possibly in a way that could promote better tumor clearance when combined with other treatments. Overall, participation in this study will help the study team better understand the anti-tumor immune response when BCC is treated with PDT.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are being treated for other cancers with medical or radiation therapy, you cannot participate.

What data supports the effectiveness of the treatment ALA, Aminolevulinic Acid, Levulan, Ameluz for basal cell carcinoma?

Research shows that photodynamic therapy (PDT) using aminolevulinic acid (ALA) is effective for treating superficial basal cell carcinoma, offering benefits like minimal scarring and good cosmetic results. It is also noted for its ability to treat multiple skin lesions at once. ^{1 2 3 4 5}

Is photodynamic therapy (PDT) using aminolevulinic acid (ALA) safe for treating basal cell carcinoma?

Research indicates that photodynamic therapy (PDT) using aminolevulinic acid (ALA) is generally safe for treating superficial basal cell carcinoma, with studies showing good safety profiles and minimal side effects. ^{1 3 5 6 7}

How is the treatment ALA-PDT unique for basal cell carcinoma?

ALA-PDT (Aminolevulinic Acid Photodynamic Therapy) is unique because it is a noninvasive treatment that uses light to activate a drug applied to the skin, leading to excellent cosmetic results with little to no scarring. It can treat multiple lesions at once and is particularly effective for superficial basal cell carcinoma, unlike some traditional treatments. ^{1 5 6 8 9}

Eligibility Criteria

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.

Inclusion Criteria

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

Must provide informed consent to participate

I belong to any ethnic group.

Exclusion Criteria

Known hypersensitivity to 5-aminolevulinic acid (ALA)

Pregnant or breastfeeding

I am currently receiving treatment for another cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Photodynamic Therapy (PDT) Treatment

Participants receive PDT treatment for one tumor, while the other tumor is left untreated as a control. Activities include informed consent, blood draw, lesion photography, ALA application, PpIX measurement, and PDT with blue light.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in tumor appearance, volume, and immune response. This includes a blood draw, lesion photography, and Mohs surgery.

1-14 days

1 visit (in-person)

Long-term Follow-up

Participants are monitored for distant tumor effects and long-term immune response changes.

4 weeks

Treatment Details

Interventions

• ALA (Photosensitizer)

Trial Overview 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.

Participant Groups

Group I: Photodynamic therapy (PDT) Experimental Treatment 2 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

ALA is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Aminolevulinic Acid for:

• Actinic keratosis
• Basal cell carcinoma
• Squamous cell carcinoma in situ

🇺🇸 Approved in United States as Levulan for:

• Actinic keratosis
• Basal cell carcinoma

🇨🇦 Approved in Canada as Ameluz for:

• Actinic keratosis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic, Case Comprehensive Cancer Center Cleveland, OH

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center Lead Sponsor

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of superficial basal cell carcinomas using topical 5-aminolevulinic acid in a nanocolloid lotion. [2018] Photodynamic therapy (PDT) of superficial basal cell carcinomas using endogenous protoporphyrin IX generated by topically applied 5-aminolevulinic acid (5-ALA) is an innovative and clinically encouraging approach.

2. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up and histological changes of superficial nonmelanoma skin cancers treated with topical delta-aminolevulinic acid photodynamic therapy. [2022] To investigate the immediate and long-term effects of photodynamic therapy with delta-aminolevulinic acid (ALA-PDT) on superficial basal cell carcinomas (BCC) and superficial squamous cell carcinomas (SCC).

3. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for nodular basal cell carcinoma up to 5 mm located on high-risk area: effectiveness and long-term follow-up results. [2023] Response rates evaluation of photodynamic therapy (PDT) for nodular basal cell carcinoma (BCC) treatment located on high-risk and low-risk areas of the face.

4. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy using methyl aminolevulinate acid in eyelid basal cell carcinoma: a 5-year follow-up study. [2018] To evaluate retrospectively the long-term results of methyl aminolevulinate photodynamic therapy for the treatment of eyelid basal cell carcinoma.

5. United States pubmed.ncbi.nlm.nih.gov

Aminolevulinic acid photodynamic therapy for skin cancers. [2013] Aminolevulinic acid photodynamic therapy (ALA-PDT) is an effective and noninvasive therapy for superficial basal cell carcinoma (BCC) and Bowen's disease. It also may have a role in the treatment of nodular BCC and other cutaneous malignancies, including localized cutaneous lymphomas. ALA-PDT offers multiple advantages over traditional treatments, including little to no scarring, excellent cosmetic results, and the ability to treat multiple lesions simultaneously. It is not an effective therapy for aggressive subtypes of BCC or for invasive squamous cell carcinoma. Finally, ALA-PDT may be a useful way to prevent new skin cancers in certain high-risk patients.

6. England pubmed.ncbi.nlm.nih.gov

Hexyl aminolevulinate, 5-aminolevulinic acid nanoemulsion and methyl aminolevulinate in photodynamic therapy of non-aggressive basal cell carcinomas: A non-sponsored, randomized, prospective and double-blinded trial. [2021] In the photodynamic therapy (PDT) of non-aggressive basal cell carcinomas (BCCs), 5-aminolevulinic acid nanoemulsion (BF-200ALA) has shown non-inferior efficacy when compared with methyl aminolevulinate (MAL), a widely used photosensitizer. Hexyl aminolevulinate (HAL) is an interesting alternative photosensitizer. To our knowledge, this is the first study using HAL-PDT in the treatment of BCCs.

7. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy with 5-aminolevulinate patch for the treatment of superficial basal cell carcinomas. [2021] 5-Aminolevulinate (ALA) patches with red light (630-nm light source and a total light dose of 37 J/cm2 ) is an effective treatment indicated by food and drug administration (FDA) and european medicines agency (EMA) only for grade I to II actinic keratosis located on the scalp and face. Currently, there are no efficacy data on their use in the treatment of other types of epithelial neoplasms. We analyzed the efficacy of ALA patches in seven superficial basal cell carcinomas (sBCCs) that occurred in four patients. All lesions were treated with topical ALA patches. A complete response of all sBCCs was achieved at week 24 after treatment. Our study suggests that ALA patches for sBCCs have good efficacy rates and excellent safety profile.

8. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of aminolevulinic acid (ALA)-thermogel-PDT with methyl-ALA-thermogel-PDT in basal cell carcinoma. [2022] Aminolevulinic acid (ALA) and light irradiation is a treatment option in basal cell carcinomas (BCC). The development of ALA-esters with potential for greater penetration depth promises higher therapeutic success. In a pilot study, we hypothesized that the cytotoxic effect of methyl-ALA (mALA) photodynamic therapy (PDT) leads to a higher success rate compared with ALA-PDT when both are topically applied in a thermogel.

9. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of cutaneous lymphoma using 5-aminolevulinic acid topical application. [2019] Photodynamic therapy (PDT) with topical application of 5-aminolevulinic acid (ALA) is a new and effective modality for treatment of superficial basal and squamous cell carcinomas.