A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and in Transit Malignant Melanoma

Inclusion Criteria:

1. Pathologically documented melanoma, AJCC stage IIIB, IIIC or IV M1a with cutaneous
melanoma lesions accessible to electroporation. Patients with Stage IIIB or IIIC
disease may have cutaneous in-transit disease or cutaneous satellitosis and patients
with Stage IV M1a disease may have either of these with distant cutaneous metastatic
sites.

2. Age ≥ 18 years old

3. ECOG performance status 0-2

4. Patients may have had prior chemotherapy or immunotherapy (with vaccines or
Interferon or IL-2) with progression or persistent disease. All chemotherapy or
immunotherapy must be stopped 4 weeks prior to electroporation. Patients may have
had radiation therapy, but must have progressive disease after radiation therapy if
the lesions to be electroporated are within the radiation field. In addition, it must
be at least 2 weeks since administration of radiation therapy and all signs of
toxicity must have abated.

5. Must have a minimum of two eligible tumors and may have up to four eligible tumors
treated with electroporation.

6. Creatinine < 2 x upper limit of normal, and serum bilirubin within institutional
normal limits obtained within 4 weeks prior to registration.

7. Absolute neutrophil count (ANC) > 1000/mm and platelet count > 100,000 /mm within 4
weeks prior to registration.

8. Able to give informed consent and able to follow guidelines given in the study

Exclusion Criteria:

1. Prior therapy with IL-12 or prior gene therapy

2. Concurrent immunotherapy, chemotherapy, or radiation therapy

3. Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess,
etc.) at time of study entry.

4. Pregnant and breast feeding women are excluded from the study because effects on the
fetus are unknown and there may be a risk of increased fetal wastage.

5. Women of childbearing age must have a negative pregnancy test and be willing to use a
highly effective method of contraception. Men who are sexually active must also be
willing to use an accepted and effective method of contraception.

6. Patients with electronic pacemakers or defibrillators are excluded from this study as
the effect of electroporation on these devices is unknown.

7. Life expectancy of less than 6 months