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
- Conditions
- LymphomaNon-melanomatous Skin CancerPrecancerous Condition
- Interventions
- Registration Number
- NCT00103246
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy silicon phthalocyanine 4 Topical silicon phthalocyanine 4 (Pc 4) followed by photodynamic therapy.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose 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 at 24 hours and 2 weeks after the start of study treatment Treatment efficacy as measured by physical exam and punch biopsy at 24 hours and 2 weeks after the start of study treatment Systemic photosensitivity as measured by minimum erythema dose (MED) testing at 2, 24, and 48 hours after completion of photodynamic therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States