Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides
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 patients with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.
Non-melanomatous Skin Cancer
Drug: silicon phthalocyanine 4
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions|
- Maximum tolerated dose [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
- Local toxicity as measured by physical exam and punch biopsy [ Time Frame: at 24 hours and 2 weeks after the start of study treatment ] [ Designated as safety issue: Yes ]
- Treatment efficacy as measured by physical exam and punch biopsy [ Time Frame: at 24 hours and 2 weeks after the start of study treatment ] [ Designated as safety issue: No ]
- Systemic photosensitivity as measured by minimum erythema dose (MED) testing [ Time Frame: at 2, 24, and 48 hours after completion of photodynamic therapy ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||August 2010|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Drug: silicon phthalocyanine 4
- 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 patients.
- 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 the MTD.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103246
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Kevin Cooper, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Principal Investigator:||Elma Baron, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|