Photodynamic Therapy for Basal Cell Carcinoma

Overseen By Allan Halpern, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Immunosuppressants, Pain medications

Disqualifiers: High-risk BCC, Gorlin syndrome, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.

Research Team

Anthony Rossi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with small, untreated basal cell carcinoma on the scalp, extremities, or trunk. Participants must be in good health, able to take photos of their skin cancer and use a smartphone app. Pregnant women, those with certain BCC subtypes or skin conditions that could affect results are excluded.

Inclusion Criteria

Owner of a smartphone (Android or iPhone). Patients without a working smartphone will not be considered eligible for this study

Being able to download application on their phone

I am legally able to make my own decisions and can sign consent forms.

Exclusion Criteria

You have a history of keloids that are considered important to the doctor conducting the study.

You have other skin conditions in the area where the treatment will be applied.

Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PDT treatment with jet-injections of ALA followed by 3h incubation and illumination with red light. Treatment is repeated after 2 weeks.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at Day 0, Day 3, Day 14, Day 17, and 3 months post-treatment.

3 months

Multiple visits (in-person)

Treatment Details

Interventions

• Illumination
• Incubation
• Jet injection of ALA
• Surgical excision

Trial Overview The study tests if using a jet-injection device to inject ALA into the skin followed by light activation is an effective treatment for basal cell carcinoma. It aims to determine safety and severity of side effects associated with this photodynamic therapy approach.

Participant Groups

Group I: Tumor Excision, No Illumination Experimental Treatment 3 Interventions

The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.

Group II: PDT treatment with jet-injections Experimental Treatment 4 Interventions

Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+