A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer

Inclusion criteria

• Patients > 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated.
• ECOG performance status < 3.
• Patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
• Patients must not have received radiation therapy to the target site within 60 days of enrolling on this study.
• Skin of target site and control site must be grade 0 or 1 by Common Terminology
• Patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver CLIPT (10 x 10 cm, or 3 x 3).
• If located on an extremity, the target lesion must not cover more than 50% of the diameter of the extremity at the level at which it is located.
• Absolute neutrophil count > 1000.
• Adequate coagulation status as indicated by platelet count > 50,000, PT and PTT < 1.5 time the upper limit of normal.
• Patients must sign informed consent.

Exclusion criteria

• Male patients not considered for this study.
• Patients must have a target lesion in a location other than the hands, feet, genitals, or face. Lesions in those locations will be excluded.
• Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded.
• Pregnant and nursing patients will be excluded. Women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment.
• Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, St. John's wort and amiodarone) will be excluded.
• Patients with severe hepatic dysfunction (total bilirubin, AST, or ALT > five times upper limit of normal) will be excluded.