PV-10 Chemoablation of Recurrent Breast Carcinoma

Exclusion Criteria

• •Radiation therapy to study lesions within 4 weeks
• •Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin)
• •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, or who are lactating
• •Known or suspected brain metastases or spinal cord compression.