A Pilot Study of Pivanex 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.