Lymphoma Clinical Trial
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
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.
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