RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using silicon phthalocyanine 4 may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using silicon phthalocyanine 4 in treating participants with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.
OBJECTIVES: * Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in participants with actinic keratosis, Bowen's disease, squamous cell or basal cell skin cancer, or stage IA, IB, IIA, or IIB mycosis fungoides. * Determine the safety and toxicity of this therapy with emphasis on whether it induces photosensitivity in non-treated sites in these participants . * Determine the antitumor mechanism of this therapy, by monitoring tissue changes via clinical, histological, immunohistochemical, and other biochemical markers, in these participants. * Determine, preliminarily, the dose of this therapy that results in highest clearing rates in these participants. OUTLINE: This is a dose-escalation study. Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present). Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. Three additional participants are treated at the MTD. After completion of study therapy, participants are followed for up to 2 weeks. PROJECTED ACCRUAL: A total of 16-45 participants will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present).Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Maximum tolerated dose
Time frame: Treatment repeats weekly for up to 3 weeks. Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.
Local toxicity as measured by physical exam and punch biopsy
Time frame: at 24 hours and 2 weeks after the start of study treatment
Treatment efficacy as measured by physical exam and punch biopsy
Time frame: at 24 hours and 2 weeks after the start of study treatment
Systemic photosensitivity as measured by minimum erythema dose (MED) testing
Time frame: at 2, 24, and 48 hours after completion of photodynamic therapy
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