Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin

• Status: Terminated
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for skin cancer and cancer that is metastatic to the skin.

PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Silicon; Silicon phthalocyanine

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)