Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/1/2019 |
| Start Date: | November 2011 |
| End Date: | November 2019 |
Photodynamic Therapy for Benign Dermal Neurofibromas Using Levulan Kerastick For Topical Solution, Plus Illumination With Red Light
GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic
therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin.
SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and
efficacy of PDT using 5-aminolevulinic acid (ALA) and 630 nm light in the treatment of benign
dermal neurofibromas.
Specifically, the primary goal of the current study is to determine the maximum tolerable
light doses that can be administered to subjects undergoing topical photoillumination
photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical
Solution.
therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin.
SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and
efficacy of PDT using 5-aminolevulinic acid (ALA) and 630 nm light in the treatment of benign
dermal neurofibromas.
Specifically, the primary goal of the current study is to determine the maximum tolerable
light doses that can be administered to subjects undergoing topical photoillumination
photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical
Solution.
STUDY DESIGN This protocol is a Phase I light dose escalation pilot study to determine the
safety and, secondarily, the efficacy of PDT using Levulan and 630 nm light in the treatment
of benign dermal neurofibromas. This protocol represents the first two parts of a planned
three part study including both pediatric and adult subjects. Part 1 will consist of studying
the penetration and uptake of the PS in neurofibromas that are scheduled for excision. These
tumors will be excised for therapeutic reasons unrelated to this study, and so this study
will place no further burden on the subject other than a 3-24 hr incubation of the Levulan on
the tumor prior to excision. The primary hypothesis to be tested is whether Levulan will
accumulate, and be converted to PpIX, by the tumor tissue more than by the surrounding normal
tissue. Secondary hypotheses are that tumors incubated with Levulan will show greater
fluorescence than untreated tumors and tumors incubated with vehicle only (placebo
application).
As the Institutional Review Boards involved generally desire pilot data on adult populations
first, we will with then proceed with the adult clinical trial portion of this protocol as
part 2. Part 2 will use the optimum incubation time, if one has been identified in part 1,
and add a dose escalation study of the amount of red light used to activate the Levulan. Part
3, with pediatric subjects, will commence at a future date, pending review of the initial
adult study results.
safety and, secondarily, the efficacy of PDT using Levulan and 630 nm light in the treatment
of benign dermal neurofibromas. This protocol represents the first two parts of a planned
three part study including both pediatric and adult subjects. Part 1 will consist of studying
the penetration and uptake of the PS in neurofibromas that are scheduled for excision. These
tumors will be excised for therapeutic reasons unrelated to this study, and so this study
will place no further burden on the subject other than a 3-24 hr incubation of the Levulan on
the tumor prior to excision. The primary hypothesis to be tested is whether Levulan will
accumulate, and be converted to PpIX, by the tumor tissue more than by the surrounding normal
tissue. Secondary hypotheses are that tumors incubated with Levulan will show greater
fluorescence than untreated tumors and tumors incubated with vehicle only (placebo
application).
As the Institutional Review Boards involved generally desire pilot data on adult populations
first, we will with then proceed with the adult clinical trial portion of this protocol as
part 2. Part 2 will use the optimum incubation time, if one has been identified in part 1,
and add a dose escalation study of the amount of red light used to activate the Levulan. Part
3, with pediatric subjects, will commence at a future date, pending review of the initial
adult study results.
Inclusion Criteria:
Subjects with NF1 will be selected for photodynamic therapy on the following criteria.
1. Age: 18 years or older.
2. NF1 will be diagnosed by American Academy of Neurology guidelines.
3. Location of tumor: cutaneous, trunk or limbs only.
4. Tumor type: superficial dermal neurofibromas, less than or equal to 4 mm deep.
5. Growth confirmation: direct measurement for the dermal neurofibromas, ruler and
photo-volumetric method.
6. Informed consent of subject.
7. Absence of any other malignancy.
8. Only failures to meet criteria 1-6 due to the primary disease will be disqualifying
Exclusion Criteria:
Subjects will be excluded from participation in the study on the basis of the following:
1. Life expectancy less than 1 year.
2. Pregnancy.
3. Inability to consent.
4. Cutaneous photosensitivity to the wavelengths used to activate PDT.
5. A diagnosis of porphyria.
6. Allergy to aminolevulinic acid or any of the Topical Solution Vehicle components.
7. Previous chemotherapy within 6 weeks of proposed PDT.
8. Other concurrent tumor therapy. -
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