Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies

Inclusion Criteria

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)