Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions
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:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Fitzpatrick skin type I-IV
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patient must use effective contraception
No diabetes mellitus
No known hypersensitivity to ethanol or propylene glycol
No significant history of photosensitivity, including diagnosis of any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 2 weeks since prior topical, local, or systemic anticancer therapy
More than 2 weeks since prior anticancer phototherapy
More than 2 weeks since prior photosensitizing medications, including any of the following:
No other concurrent photosensitizing medications
No concurrent therapeutic dose of warfarin that may cause excessive bleeding during skin biopsy