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