Intralesional PV-10 Chemoablation of Metastatic Melanoma

Inclusion Criteria: Histologically or cytologically confirmed metastatic melanoma, American Joint Committee on Cancer (AJCC) Stage III (regional lymph node metastasis, in-transit metastasis or satellite metastasis) or Stage IV (distant metastasis) Measurable disease in at least two lesions, each lesion ≤ 6 cm in diameter Performance status: ECOG 0-2 Life expectancy: at least 6 months Hematopoietic: White blood cell count (WBC) at least 3000/mm3 Absolute neutrophil count (ANC) at least 1.5 (1,500/mm3) Platelet count at least 100,000/mm3 Renal function: Creatinine ≤ 2.0 mg/dL Hepatic function: Bilirubin ≤ 2.0 mg/dL AST/ALT ≤ 3 times the upper limit of normal (ULN) Cardiovascular function: No major cardiovascular disease Thyroid function: T3 (serum triiodothyronine), T4 (serum thyroxine) and THS (serum thyrotropin) within normal limits Immunological function: Adequate immune system function in the opinion of the investigator Exclusion Criteria: Radiation therapy within 4 weeks or to any study lesion within 12 weeks Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin) or regional chemotherapy (limb infusion or perfusion) within 12 weeks Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks Investigational agents within 4 weeks (or 5 half-lives) Anti-tumor vaccine therapy within 12 weeks Concurrent illness: Severe diabetes or extremity complications due to diabetes Significant concurrent disease or illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the investigator, compromise subject safety or compliance or interfere with interpretation of study results Thyroid autoregulatory dysfunction, including thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, prior radioiodine- or surgically-treated Graves' hyperthyroidism, or cystic fibrosis Pregnancy or fertile female subjects who are not using effective contraception Concurrent medications: Subjects taking medications with a significant risk of photosensitization, such as thiazides, within one week (or 5 half-lives) of study treatment.