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

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.

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