Taxoprexin Treatment for Advanced Skin Melanoma

This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents including Interleukin-2 and vaccines. Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.

Inclusion criteria

• Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
• Patients must have at least one measurable lesion.
• Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed.
• At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
• At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and prior adjuvant chemotherapy.
• Patients must have Eastern Cooperative Oncology Group performance status of 0-2.
• Patients must be > 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients.
• Patients must have adequate liver and renal function.
• Patients must have adequate bone marrow function.
• Life expectancy of at least 3 months
• Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

Exclusion criteria

• Patients who have received prior therapy with any taxane.
• Patients whose primary site was the choroid (eye).
• Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
• Patients with symptomatic brain metastasis (es).
• Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
• Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
• Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
• Patients with unstable or serious concurrent medical conditions are excluded.
• Patients with a known hypersensitivity to Cremophor.