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

Completed · Phase 2

Conditions studied: Melanoma, Metastases

In brief

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.

Key facts

Study ID

NCT00099970

Run by

PDL BioPharma, Inc.

People needed

40

Starts

2004-12-01

Expected to finish

2006-03-01

Last updated by the study team

2008-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham-Comprehensive Cancer Ctr. — Birmingham, Alabama, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• UCLA School of Medicine — Los Angeles, California, United States
• Cancer Institute Medical Group, Inc. — Santa Monica, California, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Palmetto Hematology Oncology, P.C. — Spartanburg, South Carolina, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.