A Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Malignant Melanoma

Inclusion Criteria:

- Histologically or cytologically confirmed melanoma, previously treated with
chemotherapy or IL-2

- Recurrent or progressive disease after treatment.

- Measurable disease.

- Males and females, age ≥ 18 years.

- Adequate renal function with creatinine ≥ 1.5 mg/dl.

- Adequate liver function with alkaline phosphatase <= 2.5 X upper limit of normal,
SGOT and SGPT <= 1.5 X upper limit of normal and total bilirubin <= 1.5 X upper limit
of normal.

- Adequate bone marrow function: platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, and
absolute neutrophil count (ANC)≥ 1,500 cells/mm3.

- Able to give informed consent.

- Must have discontinued previous surgery, radiation therapy or cancer chemotherapy at
least four weeks prior to randomization (six weeks if a prior nitrosourea or
mitomycin C), with recovery from treatment-associated toxicity. Localized palliative
radiation therapy to non-target lesions is permitted within the four weeks prior to
randomization.

- A predicted life expectancy of at least 6 months.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

- Receipt of more than three (3) systemic treatment regimens for malignant melanoma
(including IL-2).

- A second malignancy within the last 5 years other than curatively treated
carcinoma-in-situ or non-melanoma skin cancer.

- Pregnant or lactating females. Females of childbearing potential must have a negative
pregnancy test and all male and female patients of reproductive potential must agree
to use adequate birth control.

- Known HIV-positive patients.

- Acute medical problems, such as ischemic heart or lung disease or uncontrolled
systemic infection.

- Patients with any underlying medical conditions or circumstance, which would
contraindicate therapy with study treatment, affect compliance or impair evaluation
of study endpoints.

- Patients receiving investigational agents within 4 weeks of randomization.

- Known allergy to reagents in the study.

- Symptomatic or untreated brain metastases – Patients with brain metastases are
eligible if they are clinically and neurologically stable for ≥ 4 weeks since therapy
(radiation therapy, radiosurgery/gamma knife, surgical resection) as determined by
the investigator and either off corticosteroids or on a stable dose of
corticosteroids.