• Toxicity as assessed by physical exam and laboratory data weekly for 4 weeks and in week 6 [ Designated as safety issue: Yes ]
  
• Disease response as measured by skin assessment and photography weekly for 4 weeks and in week 6 [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the maximum tolerated dose (MTD) of silicon phthalocyanine 4 (Pc 4) when administered with a fixed dose of light in patients with advanced cutaneous malignancies.
• Determine the MTD of the light when administered with a fixed dose of study drug in these patients.
• Determine the pharmacokinetics of Pc 4 in these patients.
• Determine the clinical antitumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of Pc 4 and a fixed dose of light until the maximum tolerated dose (MTD) of Pc 4 is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD for Pc 4 is determined, additional patients are treated with a fixed dose of Pc 4 (2 dose levels below the MTD) and escalating doses of light until the MTD is determined. The MTD of light is defined as above.

Patients are followed at 6 weeks (or 8 weeks if treated lesion on lower extremity has not healed) and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study annually.

DISEASE CHARACTERISTICS:

• Histologically confirmed tumor for which no potential curative therapy exists (e.g., surgery, radiotherapy, or systemic chemotherapy)

  • The following tumor types are eligible:

    • Cutaneous nodular metastatic breast carcinoma lesion with loco-regional cutaneous, soft tissue, or chest wall involvement

      • No chest wall recurrence without prior radiotherapy
      • Other metastatic sites allowed provided patient is concurrently receiving hormonal therapy or trastuzumab (Herceptin) of at least 4 weeks duration
    • Cutaneous or superficial subcutaneous nodular metastatic head and neck lesion
    • Cutaneous nodular Kaposi's sarcoma lesion

    • Stage IA-IIB or IVA cutaneous T-cell lymphoma (CTCL)

      • CTCL patches, plaques, or tumors with a surface area of up to 25 cm^2 if other areas of involved skin are blocked from therapy
    • Squamous cell or basal cell carcinoma of the skin that is not eligible for standard therapy (e.g., cryosurgery, radiotherapy, electrodesiccation and curettage, or excision)
    • Cutaneous and subcutaneous metastasis from any solid tumor (e.g., thoracic, gastrointestinal, or genitourinary cancers or sarcomas)

• Bidimensionally measurable disease

  • No more than 2 lesions may be treated
• No single area greater than 36 cm^2 may be treated (maximum of 25 cm^2 tumor mass with a 1 cm margin)
• Tumor treatable by surface (non-contact) light illumination
• Skin type I-III
• No tumors of the eyelids

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Hemoglobin at least 9 g/dL
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• AST/ALT no greater than 2 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2 times ULN
• No history of hepatic cirrhosis
• No hepatic disease requiring therapy

Renal:

• Creatinine no greater than 2.0 mg/dL OR
• Creatinine clearance at least 50 mL/min
• No renal disease requiring therapy

Cardiovascular:

• No myocardial infarction within the past 6 months
• No significant congestive heart failure requiring therapy
• No peripheral vascular disease

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Antinuclear antibody negative
• No sepsis
• No prior allergic or hypersensitivity reaction to paclitaxel vehicle
• No known photosensitivity diseases such as porphyria, systemic lupus erythematosus, xeroderma pigmentosum, or polymorphous light eruption
• No symptomatic collagen vascular disease
• Insulin-dependent or adult-onset diabetes mellitus allowed provided there are no lower extremity lesions

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics
• At least 4 weeks since prior immunotherapy
• No concurrent immunotherapy

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior systemic chemotherapy
• No concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics
• No concurrent corticosteroids

Radiotherapy:

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy
• More than 4 weeks since prior ultraviolet B light therapy or psoralen-ultraviolet light therapy to non-study lesions/areas
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 5 days since prior warfarin
• At least 4 weeks since prior investigational drugs
• At least 4 weeks since prior local therapy to study lesions
• At least 6 months since prior photodynamic therapy
• No concurrent aspirin, aspirin-containing medications, or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin, or cyclo-oxygenase [COX]-1 and COX-2 inhibitors)
• No other concurrent photosensitizing medications such as tetracyclines, psoralens, nalidixic acid, griseofulvin, sulfa drugs, hydrochlorothiazide, furosemide, phenothiazines, or amiodarone
• No concurrent therapeutic dosages of warfarin (non-therapeutic dosages allowed)