A Phase Ib, Open-Label, Multicenter Trial of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate the Tolerability, Safety, and Pharmacokinetics in Subjects With Newly-Diagnosed or Recurrent Unresectable Stage III or Stage IV 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