RECRUITING

Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

Conditions

NEUROFIBROMATOSIS 1 NF1 Neurofibroma Neurofibromatosis Type 1

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1). The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

Official Title

Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II

Quick Facts

Study Start:2016-08

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02728388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient is 14 years or older. 2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section). 3. Tumor Location: cutaneous, trunk, or limbs only. 4. Tumor Type: superficial dermal neurofibromas ≤4mm deep. 5. Patient has provided written informed consent. 6. Patient is willing to and can comply with study follow-up requirements. 7. Absence of any other malignancy.	1. Life expectancy less than 3 years. 2. Pregnancy. 3. Cutaneous photosensitivity to the wavelengths used to active PDT. 4. A diagnosis of porphyria. 5. Allergy to aminolevulinic acid or any of the topical solution vehicle components. 6. Previous chemotherapy within 6 weeks of proposed PDT. 7. Other concurrent tumor therapy.

Inclusion Criteria

Exclusion Criteria

1. Patient is 14 years or older.
2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section).
3. Tumor Location: cutaneous, trunk, or limbs only.
4. Tumor Type: superficial dermal neurofibromas ≤4mm deep.
5. Patient has provided written informed consent.
6. Patient is willing to and can comply with study follow-up requirements.
7. Absence of any other malignancy.

1. Life expectancy less than 3 years.
2. Pregnancy.
3. Cutaneous photosensitivity to the wavelengths used to active PDT.
4. A diagnosis of porphyria.
5. Allergy to aminolevulinic acid or any of the topical solution vehicle components.
6. Previous chemotherapy within 6 weeks of proposed PDT.
7. Other concurrent tumor therapy.

Contacts and Locations

Study Contact

Donald G Basel, MD

CONTACT

414-266-4921

dbasel@mcw.edu

Paula Engelking, BS, CRC

CONTACT

414-266-3289

pengelki@mcw.edu

Principal Investigator

Donald G Basel, MD

STUDY_DIRECTOR

Medical College of Wisconsin

Study Locations (Sites)

Donald G Basel

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Donald Basel

Donald G Basel, MD, STUDY_DIRECTOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08

Study Completion Date2025-12

Study Record Updates

Study Start Date2016-08

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

NF1
Neurofibroma
Neurofibromatosis Type 1

Additional Relevant MeSH Terms

NEUROFIBROMATOSIS 1