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

Phase 2

Completed

• Conditions: Melanoma; Metastases

• Registration Number: NCT00099970
• Lead Sponsor: PDL BioPharma, Inc.

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 for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2004-12-21
• Study First Submitted QC: 2004-12-21
• Study First Posted: 2004-12-22
• Study Completion: 2006-03
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-02
• Last Update Posted: 2008-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a confirmed tumor response at any time during the study.

Secondary Outcome Measures

Name	Time	Method
Time to disease progression
Immunogenicity
Duration of tumor response
Pharmacokinetics (PK)

Trial Locations

Locations (7)

Cancer Institute Medical Group, Inc.; 🇺🇸 Santa Monica, California, United States

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, 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

University of Alabama at Birmingham-Comprehensive Cancer Ctr.; 🇺🇸 Birmingham, Alabama, United States