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Photosensitizer

Photodynamic Therapy for Basal Cell Carcinoma

Phase 2

Waitlist Available

Led By Anthony Rossi, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Legally competent, able to give verbal and written informed consent

Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC(s) or nodular BCC(s) < 1 cm in diameter on scalp, extremities, or trunk

Must not have

Diagnosed with gorlin syndrome

Receiving immunosuppressive medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a skin cancer treatment that uses a light-activated drug is safe and has few side effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, potential side effects may include reactions at the injection site such as redness or swelling, pain during illumination and possible scarring given it's a treatment involving the skin.

Eligibility Criteria

Inclusion Criteria

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

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

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My skin cancer is confirmed, untreated, and less than 1 cm in size on specific body parts.

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I am 18 years old or older.

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I have superficial or nodular basal cell carcinoma.

Exclusion Criteria

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

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I have been diagnosed with Gorlin syndrome.

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I am currently taking medication that suppresses my immune system.

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My skin cancer is of the morpheaform subtype.

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My skin cancer is considered high-risk due to its size or location.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinical evaluation of local skin responses 3 months post treatment

Clinical evaluation of local skin responses on Day 0

Clinical evaluation of local skin responses on Day 14

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surgical excision

2015

N/A

~550

0 / 8Eligibility criteria met