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Photosensitizer

Photodynamic Therapy for Neurofibromatosis

Phase 2

Recruiting

Research Sponsored by Donald Basel

Eligibility Criteria Checklist

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

Must have

Diagnosed NF1, determined by American Academy of Neurology Guidelines

Patient is 14 years or older

Must not have

A diagnosis of porphyria

Cutaneous photosensitivity to the wavelengths used to active PDT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for neurofibromas in patients with NF1. The treatment involves using a light-activated drug (Levulan Kerastick) and red light to kill the neurofibromas. The investigators will measure how well the treatment works and how long it works for.

Who is the study for?

This trial is for individuals aged 14 or older with neurofibromatosis type 1 (NF1), specifically those with superficial skin tumors on the trunk or limbs. Participants must not have other cancers, be pregnant, have a life expectancy under three years, or be sensitive to light used in therapy. They should not have had recent chemotherapy and must agree to follow-up requirements.

What is being tested?

The study tests Levulan Kerastick topical photosensitizer combined with red light photodynamic therapy (PDT) on benign skin tumors in NF1 patients. It aims to observe how long before the treated tumors progress compared to untreated ones and understand tumor growth rates.

What are the potential side effects?

Potential side effects may include skin reactions at the treatment site such as redness, pain, burning sensation, peeling or swelling. There might also be sensitivity to sunlight or artificial light sources like sunlamps.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with NF1 according to specific guidelines.

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I am 14 years old or older.

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My cancer is located on my skin, trunk, or limbs.

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My skin tumors are less than 4mm deep.

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I do not have any other type of cancer.

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 porphyria.

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I am sensitive to light used in photodynamic therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Time to disease progression

Secondary study objectives

Tumor growth rate

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: PDT TreatmentExperimental Treatment1 Intervention

Each subject will have either placebo or Levulan Kerastick topical application applied to matched sets of neurofibromas. Each subject will have both sets, in order to serve as his/her own control subject. 16 to 24 hours post study drug treatment, both sets of neurofibromas, Levulan and placebo treated, will be irradiated with red light (630 nm) from an Omnilux Revive light device at 100 mW/cm2 for 1000 seconds (16.7 minutes).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

aminolevulinic acid

1997

Completed Phase 2

~260

0 / 7Eligibility criteria met