IL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer

Inclusion Criteria

• •Patients must have biopsy-confirmed Merkel cell carcinoma
• •Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable intratumoral injection and electroporation; the injectable lesion must not be in close proximity to another tissue (e.g. nerve, bone) that could put patient safety at risk
• •Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2
• •Life expectancy of greater than three months
• •Absolute neutrophil count \> 1,000/uL
• •Platelet count \> 50,000/uL
• •Creatinine =\< 2.0 x upper limit of normal (ULN)
• •Bilirubin =\< 2.0 x ULN
• •Prothrombin time (PT) and partial thromboplastin time (PTT) =\< 1.5 x ULN
• •Patients must be willing, at the time of the entry to the study, to undergo the pre-treatment fine needle aspiration (FNA) plus biopsy (if indicated) AND the post-treatment FNA plus biopsy (or surgery) of at least one injected lesion (FNA is essential to determine the primary endpoint of the study); NOTE: The pre-treatment biopsy will be obtained from a superficial not-to-be-injected lesion; the post-treatment biopsy of an injected lesion will be obviated if definitive surgical resection is planned
• •The effects of this treatment approach on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• •Patients must have the ability to understand and the willingness to sign a written informed consent document
• •Both men and women, and members of all races and ethnic groups are eligible for this trial