Blue-Light Therapy + Sonidegib for Basal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

Overseen byNathalie Zeitouni, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Nathalie Zeitouni

No Placebo Group

Trial Summary

What is the purpose of this trial?

This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma lesions. Basal cell carcinoma lesions are typically treated by freezing the lesion or surgically removing the lesion. These types of treatment can cause scarring. Photodynamic therapy uses light along with a drug applied to the skin to kill the cancer cells and cause them to break apart. The light used can cause the skin to feel warm, but does not cause scarring.

Eligibility Criteria

This trial is for individuals with multiple basal cell carcinoma lesions, a common type of skin cancer. It's aimed at those who seek an alternative to freezing or surgical removal, which can leave scars.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document in English

Evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial

I am a man or a woman unable to have children, and I am 18 or older.

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Exclusion Criteria

Subjects who have received any type of solid organ transplant

A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures

Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed

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Treatment Details

Interventions

Blue-Light Photodynamic Therapy (Cancer Vaccine)
Sonidegib (Hedgehog Pathway Inhibitor)

Trial OverviewThe study tests combining Blue-light photodynamic therapy (using the BLU-U device and a drug called ALA) with Sonidegib medication to treat skin cancer without scarring.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Blue-Light Photodynamic Therapy and SonidegibExperimental Treatment2 Interventions

All subjects will receive Sonidegib (ODOMZO) 200mg by mouth every day on an empty stomach (1 hour before or 2 hours after a meal) for 3 months, and PDT with topical application of ALA for a total of 3 sessions. PDT will be first administered at Visit 3 (Day 7), Visit 4 (Day 30), and Visit 5 (Day 90).