CP-461 in the Treatment of Patients With Advanced Melanoma

Inclusion Criteria

• •Histologically confirmed malignant melanoma that is advanced or metastatic.
• •Patients may have received up to 2 prior systemic chemotherapy regimens (including dacarbazine, and alternative dosing schedule of temozolomide). The last chemotherapy must have been at least 4 weeks prior to study drug administration.
• •Prior radiation therapy will be allowed. Radiotherapy must have been completed at least 4 weeks prior to study drug administration.
• •Patients may have received prior surgery. At least 4 weeks must have elapsed and patients must have recovered from all side effects associated with surgery.
• •Patients with measurable disease. At least one bidimensionally measurable lesion with clearly defined margins documented by: medical photograph for skin and oral lesions, plain X-ray with at least one diameter 0.5 cm or greater, CT, MRI, or palpation with both diameters 2 cm or greater. A radiated bony lesion may not be considered an evaluable lesion, unless there is evidence of disease progression at that site prior to administration of study drug.
• •Clinical parameters: Life expectancy \> 2 months, Age \>18 years, ECOG performance status 0-2
• •Patients should have adequate organ function related to the following: White count \> 3000/ul, Platelet count \> 70,000/ul, Hemoglobin \> 8 g/l, Bilirubin WNL, AST and ALT \< 2.5 x ULN, and Creatinine \< 1.5 x ULN or 24 hour creatinine clearance \> 60 ml/min
• •There should be no acute infection requiring systemic antibiotics.
• •Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.