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: Lymphoma; Non-melanomatous Skin Cancer; Precancerous Condition

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.

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.

Eligibility criteria:
disease characteristics: * histologically confirmed diagnosis of 1 of the following: * actinic keratosis * bowen's disease * squamous cell skin cancer * basal cell skin cancer * clinical stage ia, ib, iia, or iib mycosis fungoides * fitzpatrick skin type i-iv patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified 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: * porphyria * lupus erythematosus * xeroderma pigmentosum * severe polymorphous light eruption * solar urticaria prior concurrent therapy: biologic therapy * not specified chemotherapy * no concurrent chemotherapy endocrine therapy * not specified radiotherapy * more than 2 weeks since prior anticancer radiotherapy * no concurrent radiotherapy surgery * lesions must be healed after prior biopsy 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: * tetracyclines * quinolones * psoralens * hydrochlorothiazide * furosemide * trimethoprim-sulfamethoxazole * griseofulvin * nalidixic acid * amiodarone * phenothiazines * high-dose nonsteroidal anti-inflammatory drugs * no other concurrent photosensitizing medications * no concurrent therapeutic dose of warfarin that may cause excessive bleeding during skin biopsy

Keywords: skin cancer squamous cell carcinoma of the skin basal cell carcinoma of the skin recurrent skin cancer recurrent mycosis fungoides/sezary syndrome stage i mycosis fungoides/sezary syndrome stage ii mycosis fungoides/sezary syndrome actinic keratosis recurrent cutaneous t-cell non-hodgkin lymphoma stage i cutaneous t-cell non-hodgkin lymphoma stage ii cutaneous t-cell non-hodgkin lymphoma