Photodynamic Therapy for Basal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

Overseen byAnthony Rossi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

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.

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.

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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

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Treatment Details

Interventions

Illumination (Procedure)
Incubation (Other)
Jet injection of ALA (Photosensitizer)
Surgical excision (Procedure)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: Tumor Excision, No IlluminationExperimental Treatment3 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-injectionsExperimental Treatment4 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.