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Cancer Vaccine

Blue-Light Therapy + Sonidegib for Basal Cell Carcinoma

Phase 1

Waitlist Available

Led By Nathalie Zeitouni, MD

Research Sponsored by Nathalie Zeitouni

Eligibility Criteria Checklist

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

Must have

Male or non-childbearing potential females, at least 18 years of age

Diagnosis of BCC with at least 3 nodular lesions that measure 0.5 cm to 5 cm in diameter, located on the head and neck, trunk or extremities

Must not have

Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)

Any BCC that may require Mohs surgery for definitive control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to day 180

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for people with multiple basal cell carcinoma lesions using a combination of Blue-light photodynamic therapy and Sonidegib. This treatment aims to kill cancer cells without causing sc

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include warmth on the treated skin due to light exposure during photodynamic therapy but are expected not to cause scarring.

Eligibility Criteria

Inclusion Criteria

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

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

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I have basal cell carcinoma with 3 or more nodules on my head, neck, trunk, or limbs.

Exclusion Criteria

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

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I have an aggressive type of skin cancer.

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My skin cancer might need Mohs surgery for complete removal.

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I am currently taking medication that affects my immune system.

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I have a condition that makes my skin unusually sensitive to sunlight.

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I am known to have HIV, hepatitis B, or hepatitis C.

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I haven't used specific cancer treatments like hedgehog inhibitors, biologics, or chemotherapy in the last 6 months.

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I do not have any severe illnesses or social situations that would stop me from following the study rules.

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I am currently receiving photodynamic therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to day 180 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary efficacy outcome

Review of AEs likely related to study drug

Secondary study objectives

Review of disease progression

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: 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

aminolevulinic acid HCL (ALA)

2007

Completed Phase 2

~270

0 / 10Eligibility criteria met