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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PDL BioPharma, Inc.
• Treatments: Antibodies, Monoclonal; Dacarbazine; Volociximab

Criteria

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.