Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy

Inclusion criteria

• Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa).
• Measurable disease according to Response Criteria for Solid Tumors (RECIST).
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
• Estimated survival is greater or equal to 4 months.
• Negative pregnancy test (women of childbearing potential only).
• Pretreatment laboratory levels that meet specific criteria.
• Signed informed consent, including permission to use protected health information.

Exclusion criteria

• Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies.
• Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens.
• Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
• Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
• Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200.
• Documented central nervous system (CNS) tumor or CNS metastasis.
• History of thromboembolic events and bleeding disorders within the past year.
• Medical conditions that may be exacerbated by bleeding.