Phase I/II Trial of the Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma

Inclusion Criteria:

- Patients who have non-resectable Stage IIIB or stage IV metastatic melanoma that have
progressed despite prior therapies.

- Life expectancy of at least 12 weeks.

- ECOG performance status of 0, 1 and 2.

- ≥18 years of age.

- Patients who have not received any other chemotherapeutic, biological or
investigational agent within 28 days of study drug administration.

- First line and active brain metastases (metastatic lesions to the brain that have
been adequately treated with surgery and/or appropriate radiation therapy and that
have documented stability for >4 weeks or >2 weeks if treated with stereotactic
radiosurgery, remain eligible)

Exclusion Criteria:

- Any evidence of renal dysfunction (proteinuria, estimated creatinine clearance from
serum creatinine test of <60 ml/min).

- Impaired hepatic function (liver enzymes greater than twice the upper limit of normal
or bilirubin > 2.0 except in patients with Gilbert's syndrome).

- Prior treatment with alkylating agents (including TMZ and DTIC).

- Active brain metastases (metastatic lesions to the brain that have been adequately
treated with surgery and/or appropriate radiation therapy and that have documented
stability for >4 weeks remain eligible).

- Active infections or serious general medical conditions.

- Female patients of child-bearing age who are not on adequate contraception, or are
pregnant or breast-feeding.