Status:
COMPLETED
Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy
Lead Sponsor:
PDL BioPharma, Inc.
Conditions:
Melanoma
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00099970
Start Date
December 1 2004
End Date
March 1 2006
Last Update
August 5 2008
Active Locations (7)
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1
University of Alabama at Birmingham-Comprehensive Cancer Ctr.
Birmingham, Alabama, United States, 35294-3300
2
Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
UCLA School of Medicine
Los Angeles, California, United States, 90095
4
Cancer Institute Medical Group, Inc.
Santa Monica, California, United States, 90404