Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
Breast Cancer, Head and Neck Cancer, Lymphoma
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, recurrent skin cancer, classic Kaposi sarcoma, immunosuppressive treatment related Kaposi sarcoma, AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, skin metastases, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome, male breast cancer
Eligibility 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)
Sites / Locations
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center