Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions
- Determine the maximum tolerated dose of photodynamic therapy using topically delivered
silicon phthalocyanine 4 in patients 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 patients.
- Determine the antitumor mechanism of this therapy, by monitoring tissue changes via
clinical, histological, immunohistochemical, and other biochemical markers, in these
- Determine, preliminarily, the dose of this therapy that results in highest clearing
rates in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive topical silicon phthalocyanine 4 (Pc 4). One hour later, patients 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 patients 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 patients experiences dose-limiting toxicity. Three additional patients are treated at
After completion of study therapy, patients are followed for up to 2 weeks.
PROJECTED ACCRUAL: A total of 16-45 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Treatment repeats weekly for up to 3 weeks. Cohorts of 3 patients receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.
Kevin Cooper, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|