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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
NCT02728388 |
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Date of registration:
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25/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II
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Scientific title:
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Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02728388 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Donald G Basel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical College of Wisconsin |
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Name:
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Donald G Basel, MD |
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Address:
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Telephone:
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414-266-4921 |
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Email:
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dbasel@mcw.edu |
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Affiliation:
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Name:
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Donald G Basel, MD |
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Address:
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Telephone:
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414-266-4921 |
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Email:
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dbasel@mcw.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion 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.
Exclusion Criteria:
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.
Age minimum:
14 Years
Age maximum:
30 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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NEUROFIBROMATOSIS 1
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Intervention(s)
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Drug: aminolevulinic acid
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Primary Outcome(s)
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Time to disease progression
[Time Frame: 3 years]
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Secondary Outcome(s)
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Tumor growth rate
[Time Frame: 3 years]
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Secondary ID(s)
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PRO00026795
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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