A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma

Inclusion Criteria: * Biopsy proven malignant melanoma with metastasis that is unresectable Stage III or Stage IV. Subjects with recurrent melanoma that is unresectable are also eligible * Measurable indicator metastases * Age 18 years or older * ECOG status 0-2 * An interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea * Hematocrit \> 29%, ANC \> 1500 cells/ul, platelets \> 100,000 cells/ul * Serum creatinine within the laboratory's upper limit of normal * Serum AST and ALT ≤ 1.5 x the laboratory's upper limit of normal * Subject signed informed consent prior to subject entry Exclusion Criteria: * Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen. * Subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment. * Subjects previously treated with DTIC or TMZ * Symptomatic central nervous metastases * Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study. * Confirmed diagnosis of hepatitis or HIV infection * Any m…