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 medical, psychiatric, or social problem that might interfere with the performance, completion, and/or interpretation of the trial
• Patients who have had any surgery within two weeks prior to enrollment in this study, or who have not recovered from the side effects of this or any other therapy
• Patients unwilling to comply with the protocol or who in the judgment of the Principal Investigator are unable to abide by the rules of the protocol
• Subjects who have received a potent CYP3A4 inhibitor or inducer orally or parenterally within approximately 14 days prior to enrollment
• Subjects who have received amiodarone within 30 days of study drug administration
• History of hypersensitivity reaction to more than three (3) drugs or to mannitol
• Patients who have received any investigational study agent within 30 days of Day 1 of Cycle 1